Senior Manager, Clinical Business Systems
Structure Therapeutics · South San Francisco, CA · 3 wk ago
On-siteOTHR$166k–$209k/yrFull-time
We need to output HTML fragment with sections: About Us? Actually "About Us" is a section heading? The instruction: use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should include headings for sections that have content. The posting includes "About Us" (first paragraph). That could be considered "About the role"? Actually "About Us" is company description. Could map to "About the role"? But they said e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we can use those headings if content exists. We have:
- About Us (company description) -> maybe "About the role"? But they said do NOT repeat the job title as a heading. The job title is Senior Manager, Clinical Business Systems. Not needed.
We have Position Summary (could be "About the role").
We have Job Responsibilities (list). We have Qualifications (list). We have Travel (maybe schedule? Not exactly). We have Location (maybe schedule? Not). We have Pay (base pay range). We have Benefits (list). We have maybe "Schedule" (hybrid schedule). So we can include sections: About the role (Position Summary), Responsibilities, Qualifications, Benefits, Pay, Schedule (hybrid). Also maybe "Location"? Not in list; but we could incorporate location into About the role or Schedule? Probably better to include location as part of About the role or maybe as a separate section not in list but we should only use those headings. The instruction: use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should include headings for sections that have content. The posting includes "About Us" (first paragraph). That could be considered "About the role"? Actually "About Us" is company description. Could map to "About the role"? But they said e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we can use those headings if content exists. We have:
- About Us (company description) -> maybe "About the role"? But they said do NOT repeat the job title as a heading. The job title is Senior Manager, Clinical Business Systems. Not needed.
We have Position Summary (could be "About the role").
We have Job Responsibilities (list). We have Qualifications (list). We have Travel (maybe schedule? Not exactly). We have Location (maybe schedule? Not). We have Pay (base pay range). We have Benefits (list). We have maybe "Schedule" (hybrid schedule). So we can include sections: About the role (Position Summary), Responsibilities, Qualifications, Benefits, Pay, Schedule (hybrid). Also maybe "Location"? Not in list; but we could incorporate location into About the role or Schedule? Probably better to include location as part of About the role or maybe as a separate section not in list but we should only use those headings. The instruction: use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It says e.g., meaning those are examples; we could also use other headings if needed? It says use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Likely they expect us to use those headings when applicable. We can also add other headings if needed but better to stick to those.
We have location info: could be part of "Schedule" (hybrid schedule) or maybe we can include in About the role. We'll include location details in About the role paragraph.
We have Travel: "Remote employees will need to be present for monthly connection weeks, company meetings and/or industry conferences." That's travel expectation; could be part of Schedule? Might be separate but we can include in Schedule section.
We have Pay: base pay range $166,000-$209,000.
We have Benefits: medical, dental, vision insurance, 401k match, unlimited PTO, paid holidays including winter shutdown.
We have Responsibilities: list of duties.
We have Qualifications: list.
We have maybe "Skills": not explicitly but qualifications include skills; we could combine.
We'll produce sections:
About the role
with paragraph containing Position Summary + About Us description + Location.
Responsibilities
with - items.
Qualifications
with - items.
Benefits
with - items.
Pay
with paragraph containing base pay range.
Schedule
with paragraph containing hybrid schedule expectation and travel.
We must not include boilerplate like EEO, fraud alert, notice to recruiters, etc.
We must preserve all substantive information; do not invent or summarize away detail. Must not omit details like specific systems, etc.
Let's extract details.
About Us paragraph: "Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions. Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company completed an initial public offering (IPO) in February 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location."
Position Summary: "The Senior Manager, Clinical Business Systems is responsible for the administration, support, governance, continuous improvement, and compliance of Structure Therapeutics' GxP-regulated applications. Reporting to the Associate Director, GxP Operations, this role is the primary operational owner and business partner for validated platforms supporting Clinical, Quality, Regulatory, and Technical Operations, including Veeva Vault QMS, QualityDocs, LMS, CTMS, and eTMF; Box; DocuSign; and other regulated systems. The role combines hands-on administration with process optimization, vendor management, and cross-functional collaboration to keep platforms scalable, inspection-ready, and aligned with evolving business needs."
Location: "Structure Therapeutics has a strong preference for candidates based in the San Francisco Bay Area who are able to work a hybrid schedule from the company’s office. The role is expected to require regular in-office presence to support close collaboration with cross-functional teams, executive leadership, and external partners. Candidates outside the Bay Area may be considered in exceptional cases, but the ability to work effectively on a hybrid basis in the San Francisco office is strongly preferred."
Travel: "Remote employees will need to be present for monthly connection weeks, company meetings and/or industry conferences."
Now Responsibilities list: Let's extract bullet points from the "Job Responsibilities" section.
The text under Job Responsibilities includes multiple paragraphs each starting with a bold heading? Actually they are headings like "GxP Application Administration & Support", "IT GxP Compliance & Operational Oversight", "Vendor Oversight", "Cross-Functional Partnership". Under each there are sentences.
We need to preserve all substantive information; we can turn each sentence into a list item, or we can keep paragraphs under headings? The instruction: Use - for any list of duties/requirements/benefits. So we should convert duties into list items. We can group under headings? Not required; just list items.
Let's extract each duty:
From "GxP Application Administration & Support":
- Serve as the hands-on primary administrator for GxP applications including Veeva Vault QMS, RIM, LMS, CTMS, and eTMF; Box for Life Sciences; DocuSign Part 11; and other validated systems as applicable.
- Serve as product owner for assigned GxP applications, driving platform lifecycle management, continuous improvement, and adoption.
- Manage day-to-day system administration activities including user provisioning, role assignments, configuration updates, and system maintenance activities.
- Act as the primary point of contact for GxP application support requests and IT GxP-related service tickets, ensuring timely resolution and escalation when necessary.
- Coordinate system releases, upgrades, and configuration changes in partnership with vendors and internal stakeholders while ensuring compliance with change control procedures.
- Support system validation and maintain required documentation to ensure applications remain in a validated state.
- Partner with business stakeholders to prioritize enhancement requests, recommend process improvements, and maintain application roadmaps aligned with business priorities.
- Develop and maintain system documentation, knowledge articles, and administrator procedures.
- Support end-user training, adoption, and change management for new capabilities and releases.
- Perform audit trail reviews and user access reviews.
From "IT GxP Compliance & Operational Oversight":
- Ensure validated systems remain inspection-ready through effective governance, risk-based Computer Software Assurance (CSA), and lifecycle management.
- Support regulatory inspections by providing system documentation, validation artifacts, audit evidence, and subject matter expertise.
- Conduct routine user access reviews and audit trail reviews and system compliance monitoring activities in accordance with approved procedures.
- Partner with Quality Assurance and Regulatory Affairs to ensure alignment of IT practices with GxP requirements, including data integrity (ALCOA+ principles), electronic records, and electronic signatures.
- Assist in the investigation, documentation, and remediation of GxP system deviations, incidents, and CAPAs.
- Initiate required Change Controls and monitor progress.
- Conduct gap analyses for new and existing (legacy) systems and develop remediation plans to address compliance findings and support the company’s Inspection Readiness Program.
- Support internal audits and manage CAPAs related to IT GxP findings, driving root cause analysis and timely remediation.
From "Vendor Oversight":
- Manage day-to-day relationships with managed service providers (MSPs) and GxP application vendors.
- Monitor vendor performance against service level agreements (SLAs) and operational metrics.
- Conduct periodic operational reviews with vendors to assess service quality, enhancement planning, and continuous improvement opportunities.
- Participate in vendor qualification and periodic assessment activities in collaboration with Quality and Procurement teams.
- Coordinate vendor support activities, issue resolution, and escalation management.
From "Cross-Functional Partnership":
- Partner closely with Clinical Operations, Quality Assurance, Regulatory Affairs, Pharmacovigilance, Biometrics, and Technical Operations to optimize business processes through technology.
- Act as a trusted advisor to business stakeholders by recommending scalable, compliant system solutions that improve operational efficiency and user experience.
- Collaborate with Enterprise Applications, IT Infrastructure, Cybersecurity, Quality, and Data teams to support compliant integrations and enterprise technology initiatives.
- Participate in new system implementations, upgrades, and digital transformation initiatives across the clinical technology landscape.
Now Qualifications list: extract each bullet.
From Qualifications paragraph:
- Bachelor's degree in Computer Science, Computer Engineering, Information Technology, Life Sciences, or a related field recommended.
- 8+ years of experience supporting GxP-regulated systems within the pharmaceutical, biotechnology, or medical device industries.
- Hands-on experience administering GxP platforms such as Veeva Vault, Box for Life Sciences, DocuSign, SAS, and other regulated SaaS applications.
- Deep working knowledge of global regulatory requirements for computerized systems including 21 CFR Part 11, EU Annex 11, GAMP 5, ICH guidelines, data integrity (ALCOA+), and FDA’s CSA guidance.
- Experience supporting computer system validation (CSV) and/or Computer Software Assurance (CSA) activities for regulated systems.
- Experience managing IT service tickets, vendor relationships, and managed service providers.
- Strong documentation, organizational, and problem-solving skills.
- Excellent communication and stakeholder management skills with the ability to work effectively across Quality, Clinical, Regulatory, and IT organizations.
- Experience leading cross-functional technology initiatives and translating business requirements into scalable system solutions.
- Demonstrated ability to influence stakeholders across Clinical, Quality, Regulatory, and IT organizations.
- Ability to operate independently in a fast-paced environment while managing multiple priorities.
- Veeva Vault Administrator certification preferred.
- Experience with Veeva QMS, Veeva RIM, eTMF, CTMS, or similar enterprise GxP platforms.
- Experience with clinical technologies such as CTMS, eTMF, RBQM, Study Start-Up, RTSM/IRT, or related platforms.
- Experience with Clinical, Quality, and Regulatory business processes in a biotechnology or pharmaceutical environment.
- Experience supporting regulatory inspections and internal audits.
- Knowledge of Agile, Product Ownership, or ITIL service management practices.
- Experience working within a clinical-stage biotechnology company.
Now Benefits list: from text: "medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown."
We can list each:
- Medical insurance
- Dental insurance
- Vision insurance
- 401k match
- Unlimited PTO
- Paid holidays including winter shutdown
Also mention "annual performance incentive bonus, new hire equity, and ongoing performance-based equity." That's compensation but could be part of Benefits? It's compensation but we can include in Benefits as well. The instruction: Benefits section only if posting actually states them. It does state benefits offerings including
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Likely they expect us to use those headings when applicable. We can also add other headings if needed but better to stick to those.
We have location info: could be part of "Schedule" (hybrid schedule) or maybe we can include in About the role. We'll include location details in About the role paragraph.
We have Travel: "Remote employees will need to be present for monthly connection weeks, company meetings and/or industry conferences." That's travel expectation; could be part of Schedule? Might be separate but we can include in Schedule section.
We have Pay: base pay range $166,000-$209,000.
We have Benefits: medical, dental, vision insurance, 401k match, unlimited PTO, paid holidays including winter shutdown.
We have Responsibilities: list of duties.
We have Qualifications: list.
We have maybe "Skills": not explicitly but qualifications include skills; we could combine.
We'll produce sections:
About the role
with paragraph containing Position Summary + About Us description + Location.
Responsibilities
with - items.
Qualifications
with - items.
Benefits
with - items.
Pay
with paragraph containing base pay range.
Schedule
with paragraph containing hybrid schedule expectation and travel.
We must not include boilerplate like EEO, fraud alert, notice to recruiters, etc.
We must preserve all substantive information; do not invent or summarize away detail. Must not omit details like specific systems, etc.
Let's extract details.
About Us paragraph: "Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions. Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company completed an initial public offering (IPO) in February 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location."
Position Summary: "The Senior Manager, Clinical Business Systems is responsible for the administration, support, governance, continuous improvement, and compliance of Structure Therapeutics' GxP-regulated applications. Reporting to the Associate Director, GxP Operations, this role is the primary operational owner and business partner for validated platforms supporting Clinical, Quality, Regulatory, and Technical Operations, including Veeva Vault QMS, QualityDocs, LMS, CTMS, and eTMF; Box; DocuSign; and other regulated systems. The role combines hands-on administration with process optimization, vendor management, and cross-functional collaboration to keep platforms scalable, inspection-ready, and aligned with evolving business needs."
Location: "Structure Therapeutics has a strong preference for candidates based in the San Francisco Bay Area who are able to work a hybrid schedule from the company’s office. The role is expected to require regular in-office presence to support close collaboration with cross-functional teams, executive leadership, and external partners. Candidates outside the Bay Area may be considered in exceptional cases, but the ability to work effectively on a hybrid basis in the San Francisco office is strongly preferred."
Travel: "Remote employees will need to be present for monthly connection weeks, company meetings and/or industry conferences."
Now Responsibilities list: Let's extract bullet points from the "Job Responsibilities" section.
The text under Job Responsibilities includes multiple paragraphs each starting with a bold heading? Actually they are headings like "GxP Application Administration & Support", "IT GxP Compliance & Operational Oversight", "Vendor Oversight", "Cross-Functional Partnership". Under each there are sentences.
We need to preserve all substantive information; we can turn each sentence into a list item, or we can keep paragraphs under headings? The instruction: Use - for any list of duties/requirements/benefits. So we should convert duties into list items. We can group under headings? Not required; just list items.
Let's extract each duty:
From "GxP Application Administration & Support":
- Serve as the hands-on primary administrator for GxP applications including Veeva Vault QMS, RIM, LMS, CTMS, and eTMF; Box for Life Sciences; DocuSign Part 11; and other validated systems as applicable.
- Serve as product owner for assigned GxP applications, driving platform lifecycle management, continuous improvement, and adoption.
- Manage day-to-day system administration activities including user provisioning, role assignments, configuration updates, and system maintenance activities.
- Act as the primary point of contact for GxP application support requests and IT GxP-related service tickets, ensuring timely resolution and escalation when necessary.
- Coordinate system releases, upgrades, and configuration changes in partnership with vendors and internal stakeholders while ensuring compliance with change control procedures.
- Support system validation and maintain required documentation to ensure applications remain in a validated state.
- Partner with business stakeholders to prioritize enhancement requests, recommend process improvements, and maintain application roadmaps aligned with business priorities.
- Develop and maintain system documentation, knowledge articles, and administrator procedures.
- Support end-user training, adoption, and change management for new capabilities and releases.
- Perform audit trail reviews and user access reviews.
From "IT GxP Compliance & Operational Oversight":
- Ensure validated systems remain inspection-ready through effective governance, risk-based Computer Software Assurance (CSA), and lifecycle management.
- Support regulatory inspections by providing system documentation, validation artifacts, audit evidence, and subject matter expertise.
- Conduct routine user access reviews and audit trail reviews and system compliance monitoring activities in accordance with approved procedures.
- Partner with Quality Assurance and Regulatory Affairs to ensure alignment of IT practices with GxP requirements, including data integrity (ALCOA+ principles), electronic records, and electronic signatures.
- Assist in the investigation, documentation, and remediation of GxP system deviations, incidents, and CAPAs.
- Initiate required Change Controls and monitor progress.
- Conduct gap analyses for new and existing (legacy) systems and develop remediation plans to address compliance findings and support the company’s Inspection Readiness Program.
- Support internal audits and manage CAPAs related to IT GxP findings, driving root cause analysis and timely remediation.
From "Vendor Oversight":
- Manage day-to-day relationships with managed service providers (MSPs) and GxP application vendors.
- Monitor vendor performance against service level agreements (SLAs) and operational metrics.
- Conduct periodic operational reviews with vendors to assess service quality, enhancement planning, and continuous improvement opportunities.
- Participate in vendor qualification and periodic assessment activities in collaboration with Quality and Procurement teams.
- Coordinate vendor support activities, issue resolution, and escalation management.
From "Cross-Functional Partnership":
- Partner closely with Clinical Operations, Quality Assurance, Regulatory Affairs, Pharmacovigilance, Biometrics, and Technical Operations to optimize business processes through technology.
- Act as a trusted advisor to business stakeholders by recommending scalable, compliant system solutions that improve operational efficiency and user experience.
- Collaborate with Enterprise Applications, IT Infrastructure, Cybersecurity, Quality, and Data teams to support compliant integrations and enterprise technology initiatives.
- Participate in new system implementations, upgrades, and digital transformation initiatives across the clinical technology landscape.
Now Qualifications list: extract each bullet.
From Qualifications paragraph:
- Bachelor's degree in Computer Science, Computer Engineering, Information Technology, Life Sciences, or a related field recommended.
- 8+ years of experience supporting GxP-regulated systems within the pharmaceutical, biotechnology, or medical device industries.
- Hands-on experience administering GxP platforms such as Veeva Vault, Box for Life Sciences, DocuSign, SAS, and other regulated SaaS applications.
- Deep working knowledge of global regulatory requirements for computerized systems including 21 CFR Part 11, EU Annex 11, GAMP 5, ICH guidelines, data integrity (ALCOA+), and FDA’s CSA guidance.
- Experience supporting computer system validation (CSV) and/or Computer Software Assurance (CSA) activities for regulated systems.
- Experience managing IT service tickets, vendor relationships, and managed service providers.
- Strong documentation, organizational, and problem-solving skills.
- Excellent communication and stakeholder management skills with the ability to work effectively across Quality, Clinical, Regulatory, and IT organizations.
- Experience leading cross-functional technology initiatives and translating business requirements into scalable system solutions.
- Demonstrated ability to influence stakeholders across Clinical, Quality, Regulatory, and IT organizations.
- Ability to operate independently in a fast-paced environment while managing multiple priorities.
- Veeva Vault Administrator certification preferred.
- Experience with Veeva QMS, Veeva RIM, eTMF, CTMS, or similar enterprise GxP platforms.
- Experience with clinical technologies such as CTMS, eTMF, RBQM, Study Start-Up, RTSM/IRT, or related platforms.
- Experience with Clinical, Quality, and Regulatory business processes in a biotechnology or pharmaceutical environment.
- Experience supporting regulatory inspections and internal audits.
- Knowledge of Agile, Product Ownership, or ITIL service management practices.
- Experience working within a clinical-stage biotechnology company.
Now Benefits list: from text: "medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown."
We can list each:
- Medical insurance
- Dental insurance
- Vision insurance
- 401k match
- Unlimited PTO
- Paid holidays including winter shutdown
Also mention "annual performance incentive bonus, new hire equity, and ongoing performance-based equity." That's compensation but could be part of Benefits? It's compensation but we can include in Benefits as well. The instruction: Benefits section only if posting actually states them. It does state benefits offerings including
Qualifications
with- items.
Benefits
with- items.
Pay
with paragraph containing base pay range.Schedule
with paragraph containing hybrid schedule expectation and travel. We must not include boilerplate like EEO, fraud alert, notice to recruiters, etc. We must preserve all substantive information; do not invent or summarize away detail. Must not omit details like specific systems, etc. Let's extract details. About Us paragraph: "Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions. Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company completed an initial public offering (IPO) in February 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location." Position Summary: "The Senior Manager, Clinical Business Systems is responsible for the administration, support, governance, continuous improvement, and compliance of Structure Therapeutics' GxP-regulated applications. Reporting to the Associate Director, GxP Operations, this role is the primary operational owner and business partner for validated platforms supporting Clinical, Quality, Regulatory, and Technical Operations, including Veeva Vault QMS, QualityDocs, LMS, CTMS, and eTMF; Box; DocuSign; and other regulated systems. The role combines hands-on administration with process optimization, vendor management, and cross-functional collaboration to keep platforms scalable, inspection-ready, and aligned with evolving business needs." Location: "Structure Therapeutics has a strong preference for candidates based in the San Francisco Bay Area who are able to work a hybrid schedule from the company’s office. The role is expected to require regular in-office presence to support close collaboration with cross-functional teams, executive leadership, and external partners. Candidates outside the Bay Area may be considered in exceptional cases, but the ability to work effectively on a hybrid basis in the San Francisco office is strongly preferred." Travel: "Remote employees will need to be present for monthly connection weeks, company meetings and/or industry conferences." Now Responsibilities list: Let's extract bullet points from the "Job Responsibilities" section. The text under Job Responsibilities includes multiple paragraphs each starting with a bold heading? Actually they are headings like "GxP Application Administration & Support", "IT GxP Compliance & Operational Oversight", "Vendor Oversight", "Cross-Functional Partnership". Under each there are sentences. We need to preserve all substantive information; we can turn each sentence into a list item, or we can keep paragraphs under headings? The instruction: Use- for any list of duties/requirements/benefits. So we should convert duties into list items. We can group under headings? Not required; just list items. Let's extract each duty: From "GxP Application Administration & Support": - Serve as the hands-on primary administrator for GxP applications including Veeva Vault QMS, RIM, LMS, CTMS, and eTMF; Box for Life Sciences; DocuSign Part 11; and other validated systems as applicable. - Serve as product owner for assigned GxP applications, driving platform lifecycle management, continuous improvement, and adoption. - Manage day-to-day system administration activities including user provisioning, role assignments, configuration updates, and system maintenance activities. - Act as the primary point of contact for GxP application support requests and IT GxP-related service tickets, ensuring timely resolution and escalation when necessary. - Coordinate system releases, upgrades, and configuration changes in partnership with vendors and internal stakeholders while ensuring compliance with change control procedures. - Support system validation and maintain required documentation to ensure applications remain in a validated state. - Partner with business stakeholders to prioritize enhancement requests, recommend process improvements, and maintain application roadmaps aligned with business priorities. - Develop and maintain system documentation, knowledge articles, and administrator procedures. - Support end-user training, adoption, and change management for new capabilities and releases. - Perform audit trail reviews and user access reviews. From "IT GxP Compliance & Operational Oversight": - Ensure validated systems remain inspection-ready through effective governance, risk-based Computer Software Assurance (CSA), and lifecycle management. - Support regulatory inspections by providing system documentation, validation artifacts, audit evidence, and subject matter expertise. - Conduct routine user access reviews and audit trail reviews and system compliance monitoring activities in accordance with approved procedures. - Partner with Quality Assurance and Regulatory Affairs to ensure alignment of IT practices with GxP requirements, including data integrity (ALCOA+ principles), electronic records, and electronic signatures. - Assist in the investigation, documentation, and remediation of GxP system deviations, incidents, and CAPAs. - Initiate required Change Controls and monitor progress. - Conduct gap analyses for new and existing (legacy) systems and develop remediation plans to address compliance findings and support the company’s Inspection Readiness Program. - Support internal audits and manage CAPAs related to IT GxP findings, driving root cause analysis and timely remediation. From "Vendor Oversight": - Manage day-to-day relationships with managed service providers (MSPs) and GxP application vendors. - Monitor vendor performance against service level agreements (SLAs) and operational metrics. - Conduct periodic operational reviews with vendors to assess service quality, enhancement planning, and continuous improvement opportunities. - Participate in vendor qualification and periodic assessment activities in collaboration with Quality and Procurement teams. - Coordinate vendor support activities, issue resolution, and escalation management. From "Cross-Functional Partnership": - Partner closely with Clinical Operations, Quality Assurance, Regulatory Affairs, Pharmacovigilance, Biometrics, and Technical Operations to optimize business processes through technology. - Act as a trusted advisor to business stakeholders by recommending scalable, compliant system solutions that improve operational efficiency and user experience. - Collaborate with Enterprise Applications, IT Infrastructure, Cybersecurity, Quality, and Data teams to support compliant integrations and enterprise technology initiatives. - Participate in new system implementations, upgrades, and digital transformation initiatives across the clinical technology landscape. Now Qualifications list: extract each bullet. From Qualifications paragraph: - Bachelor's degree in Computer Science, Computer Engineering, Information Technology, Life Sciences, or a related field recommended. - 8+ years of experience supporting GxP-regulated systems within the pharmaceutical, biotechnology, or medical device industries. - Hands-on experience administering GxP platforms such as Veeva Vault, Box for Life Sciences, DocuSign, SAS, and other regulated SaaS applications. - Deep working knowledge of global regulatory requirements for computerized systems including 21 CFR Part 11, EU Annex 11, GAMP 5, ICH guidelines, data integrity (ALCOA+), and FDA’s CSA guidance. - Experience supporting computer system validation (CSV) and/or Computer Software Assurance (CSA) activities for regulated systems. - Experience managing IT service tickets, vendor relationships, and managed service providers. - Strong documentation, organizational, and problem-solving skills. - Excellent communication and stakeholder management skills with the ability to work effectively across Quality, Clinical, Regulatory, and IT organizations. - Experience leading cross-functional technology initiatives and translating business requirements into scalable system solutions. - Demonstrated ability to influence stakeholders across Clinical, Quality, Regulatory, and IT organizations. - Ability to operate independently in a fast-paced environment while managing multiple priorities. - Veeva Vault Administrator certification preferred. - Experience with Veeva QMS, Veeva RIM, eTMF, CTMS, or similar enterprise GxP platforms. - Experience with clinical technologies such as CTMS, eTMF, RBQM, Study Start-Up, RTSM/IRT, or related platforms. - Experience with Clinical, Quality, and Regulatory business processes in a biotechnology or pharmaceutical environment. - Experience supporting regulatory inspections and internal audits. - Knowledge of Agile, Product Ownership, or ITIL service management practices. - Experience working within a clinical-stage biotechnology company. Now Benefits list: from text: "medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown." We can list each: - Medical insurance - Dental insurance - Vision insurance - 401k match - Unlimited PTO - Paid holidays including winter shutdown Also mention "annual performance incentive bonus, new hire equity, and ongoing performance-based equity." That's compensation but could be part of Benefits? It's compensation but we can include in Benefits as well. The instruction: Benefits section only if posting actually states them. It does state benefits offerings including
- items.