Senior Director, IT Compliance & Governance (Contract)
BioSpace · United States · 1 mo ago
RemoteRemoteInformation Technology$122–$136/hrContract
We need to output HTML fragment with sections: headings for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content.
We need to parse the posting.
First part: "Attention recruitment agencies: ..." is boilerplate, remove.
Then: "4DMT is a leading late-stage biotechnology company..." This is about the company, maybe "About the role"? Actually "General Summary" describes the role. So we can have an
for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content.
We need to parse the posting.
First part: "Attention recruitment agencies: ..." is boilerplate, remove.
Then: "4DMT is a leading late-stage biotechnology company..." This is about the company, maybe "About the role"? Actually "General Summary" describes the role. So we can have an About the role
with paragraph summarizing.
Then "Reporting to the Sr. VP, IT & Facilities, the IT Compliance & Governance Consultant is a senior IT leader with two mission-critical objectives: ..." This is part of role description.
We need to preserve all substantive info, not invent.
We need sections: Responsibilities (list), Qualifications (list), Skills (list), Pay (hourly compensation range), maybe Benefits? Not mentioned. Schedule? Not mentioned. So only include sections with content: About the role, Responsibilities, Qualifications, Skills, Pay.
We must not repeat job title as heading. Job title is "IT Compliance & Governance Consultant". Not to be used as heading.
We need to use - for any list of duties/requirements/benefits. For Responsibilities, Qualifications, Skills we should list items.
We need to extract responsibilities bullet points from the text.
Responsibilities section in posting: after "Responsibilities" heading, there are bullet-like sentences separated by semicolons? Let's extract:
"IT Compliance: Ensure 4DMT IT meets GxP, SOX & privacy requirements through an auditable control environment & strong evidence management; lead the IT GxP compliance assessment & remediation plan for the upcoming FDA inspection. Oversee execution of auditable IT activities—system validation, periodic review, backup/restore testing, change control, SOX ITGC reviews & access/inventory management—by internal teams, managed services, consultants & 3rd party service providers to ensure consistent, on-time, right-first-time execution. Serve as a collaborative partner to QA CSV/CSA, Finance Compliance (SOX) & Legal Compliance (Privacy/Transparency) to align & improve governance & compliance policies/SOPs, & execute audit/inspection preparedness activities (e.g., risk-based storyboarding, control/procedure improvements, evidence readiness drills). Act as escalation point & examiner-facing interface for IT portions of audits & health authority inspections; explain IT controls & CSV/CSA practices; coordinate IT evidence, storyboards & responses; & manage observations/CAPAs through remediation closure."
Then "IT Council Project Portfolio Own & mature technology portfolio management practices that translate strategy into a clear, funded, executable roadmap with transparent status reporting for leadership decisions; oversee critical implementation programs & drive cross-functional alignment, escalation, dependency management, & delivery discipline. Run portfolio intake, prioritization, categorization, risk/value assessment, dependency mapping, benefits tracking & portfolio reporting, with special focus on BLA, Inspection & Commercial Launch programs."
Then "IT Governance Coordinate annual planning & IT Council/steering cadences, IT procurement coordination, & budget development/forecasting & BvA spend tracking. Define, implement, & enforce IT governance across verticals through policies, SOPs, & fit-for-purpose processes, establishing ways of working (e.g., project/program governance, IT cadences, KPI/OKR framework) that improve performance & maturity. Maintain dotted-line/matrixed governance for IT project managers, IT compliance, IT procurement & system validation staff to drive consistent execution, standard work, & audit/inspection readiness across systems & programs."
We can break each sentence into list items.
Qualifications: after "Qualifications Experience:" there is a list of bullet-like statements separated by line breaks? Let's extract:
"Experience: 15+ years of IT GxP (e.g. Part 11) compliance responsibility required
12+ years directly managing or auditing IT operational processes
10+ years developing, implementing & maintaining SDLC in alignment with principles of GAMP 5
8+ years of experience in a senior IT leadership position w/demonstrated ability to lead compliance & project teams within the Biotech or Pharma industry.
Direct involvement as IT, compliance, or validation lead for at least one FDA or comparable health authority inspection, including examiner-facing preparation & response
Recent roles demonstrating expertise managing transparent IT project portfolios that enable effective steering committee oversight & portfolio health monitoring
Annual external audits of SOX IT General Control design & effectiveness, Segregation of Duties, & SSAE-18 SOC report reviews a plus
Multiple lab, scientific &/or financial software implementations (SDLC/Change Mgmt) as IT lead or compliance/validation lead.
Direct involvement as IT lead or compliance/validation lead in one or more Data Integrity or Computer System Assurance programs
Experience leading complex, cross-functional technology portfolios or commercial launch programs with dozens of concurrent projects, including roadmap governance, dependency tracking, executive reporting, vendor coordination, & delivery escalation
Education Bachelor’s Degree in a Life Science or Computer Science. Certifications related to GxP, SOX & Privacy regulations, IT operations & project management strongly preferred."
We need to treat each line as list item.
Skills: after "Skills Strong knowledge of the IT implications of cGMP, GCP & ICH guidelines, Part 11/Annex 11, Computer System Assurance, Data Integrity guidelines for US, Canada & EU markets, SOX, & privacy/transparency regulations Strong skills designing, enabling & auditing compliant IT operational processes, including SDLC, Change, Access, Inventory, Data Protection/Backup, & Service Continuity Management Strong skills using & administering GRC, QMS & LMS tools required Skills with Smartsheet, SharePoint, Box & Veeva Vault a plus. Collaborative Communication Skills: Ability to work with a diverse group of personalities & individuals at all levels Excellent document authoring, review & writing skills Strong verbal communication skills Ability to work independently, multitask, and maintain strong attention to detail & accuracy Proven ability to set schedules & meet deadlines"
We need to split into list items.
Pay: "Hourly compensation range: $122.00 - 136.00/hr Please note, the hourly compensation range offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience."
We need to include Pay section with that info.
We must not include Benefits or Schedule sections.
We need to output only HTML fragment, no /, no markdown fences.
Let's craft.
Structure:
About the role
... paragraph summarizing role ...
Responsibilities
- ...
...
Qualifications
- ...
...
Skills
- ...
...
Pay
Hourly compensation range: $122.00 - $136.00/hr. The final compensation depends on geographical location, relevant work experience, skills, and years of experience.
We need to preserve all substantive info, not invent. Ensure we don't add extra info not present. For Pay we can keep as given.
Now we need to write the About the role paragraph: combine the general summary and reporting line.
From posting: "General Summary Reporting to the Sr. VP, IT & Facilities, the IT Compliance & Governance Consultant is a senior IT leader with two mission-critical objectives: as IT’s examiner-facing leader, ensure FDA inspection success by leading IT GxP compliance assessments, remediation plans, evidence readiness, & inspection response; and drive successful delivery of the IT Council-governed technology portfolio, which includes dozens of critical BLA, Inspection & Commercial Launch-readiness projects. The role covers three core areas: IT compliance, primarily GxP & SOX; the IT Council project portfolio, including prioritization, status reporting, dependency management, & escalation, with special focus on BLA, Inspection & Commercial launch programs; and IT governance, including IT Council coordination, IT procurement, budget planning/forecasting, policies, SOPs, & cross-functional ways of working."
We can put that as paragraph.
Now responsibilities list items: we need to break into sensible items.
Let's extract each distinct responsibility:
From IT Compliance paragraph:
- Ensure 4DMT IT meets GxP, SOX & privacy requirements through an auditable control environment & strong evidence management.
- Lead the IT GxP compliance assessment & remediation plan for the upcoming FDA inspection.
- Oversee execution of auditable IT activities—system validation, periodic review, backup/restore testing, change control, SOX ITGC reviews & access/inventory management—by internal teams, managed services, consultants & 3rd party service providers to ensure consistent, on-time, right-first-time execution.
- Serve as a collaborative partner to QA CSV/CSA, Finance Compliance (SOX) & Legal Compliance (Privacy/Transparency) to align & improve governance & compliance policies/SOPs, & execute audit/inspection preparedness activities (e.g., risk-based storyboarding, control/procedure improvements, evidence readiness drills).
- Act as escalation point & examiner-facing interface for IT portions of audits & health authority inspections; explain IT controls & CSV/CSA practices; coordinate IT evidence, storyboards & responses; & manage observations/CAPAs through remediation closure.
From IT Council Project Portfolio:
- Own & mature technology portfolio management practices that translate strategy into a clear, funded, executable roadmap with transparent status reporting for leadership decisions.
- Oversee critical implementation programs & drive cross-functional alignment, escalation, dependency management, & delivery discipline.
- Run portfolio intake, prioritization, categorization, risk/value assessment, dependency mapping, benefits tracking & portfolio reporting, with special focus on BLA, Inspection & Commercial Launch programs.
From IT Governance:
- Coordinate annual planning & IT Council/steering cadences, IT procurement coordination, & budget development/forecasting & BvA spend tracking.
- Define, implement, & enforce IT governance across verticals through policies, SOPs, & fit-for-purpose processes, establishing ways of working (e.g., project/program governance, IT cadences, KPI/OKR framework) that improve performance & maturity.
- Maintain dotted-line/matrixed governance for IT project managers, IT compliance, IT procurement & system validation staff to drive consistent execution, standard work, & audit/inspection readiness across systems & programs.
Now Qualifications list items: each line.
Let's list:
- 15+ years of IT GxP (e.g. Part 11) compliance responsibility required
- 12+ years directly managing or auditing IT operational processes
- 10+ years developing, implementing & maintaining SDLC in alignment with principles of GAMP 5
- 8+ years of experience in a senior IT leadership position with demonstrated ability to lead compliance & project teams within the Biotech or Pharma industry.
- Direct involvement as IT, compliance, or validation lead for at least one FDA or comparable health authority inspection, including examiner-facing preparation & response
- Recent roles demonstrating expertise managing transparent IT project portfolios that enable effective steering committee oversight & portfolio health monitoring
- Annual external audits of SOX IT General Control design & effectiveness, Segregation of Duties, & SSAE-18 SOC report reviews a plus
- Multiple lab, scientific &/or financial software implementations (SDLC/Change Mgmt) as IT lead or compliance/validation lead.
- Direct involvement as IT lead or compliance/validation lead in one or more Data Integrity or Computer System Assurance programs
- Experience leading complex, cross-functional technology portfolios or commercial launch programs with dozens of concurrent projects, including roadmap governance, dependency tracking, executive reporting, vendor coordination, & delivery escalation
- Education: Bachelor’s Degree in a Life Science or Computer Science.
- Certifications
About the role
... paragraph summarizing role ...
Responsibilities
- ... ...
Qualifications
- ... ...
Skills
- ... ...
Pay
Hourly compensation range: $122.00 - $136.00/hr. The final compensation depends on geographical location, relevant work experience, skills, and years of experience.
We need to preserve all substantive info, not invent. Ensure we don't add extra info not present. For Pay we can keep as given. Now we need to write the About the role paragraph: combine the general summary and reporting line. From posting: "General Summary Reporting to the Sr. VP, IT & Facilities, the IT Compliance & Governance Consultant is a senior IT leader with two mission-critical objectives: as IT’s examiner-facing leader, ensure FDA inspection success by leading IT GxP compliance assessments, remediation plans, evidence readiness, & inspection response; and drive successful delivery of the IT Council-governed technology portfolio, which includes dozens of critical BLA, Inspection & Commercial Launch-readiness projects. The role covers three core areas: IT compliance, primarily GxP & SOX; the IT Council project portfolio, including prioritization, status reporting, dependency management, & escalation, with special focus on BLA, Inspection & Commercial launch programs; and IT governance, including IT Council coordination, IT procurement, budget planning/forecasting, policies, SOPs, & cross-functional ways of working." We can put that as paragraph. Now responsibilities list items: we need to break into sensible items. Let's extract each distinct responsibility: From IT Compliance paragraph: - Ensure 4DMT IT meets GxP, SOX & privacy requirements through an auditable control environment & strong evidence management. - Lead the IT GxP compliance assessment & remediation plan for the upcoming FDA inspection. - Oversee execution of auditable IT activities—system validation, periodic review, backup/restore testing, change control, SOX ITGC reviews & access/inventory management—by internal teams, managed services, consultants & 3rd party service providers to ensure consistent, on-time, right-first-time execution. - Serve as a collaborative partner to QA CSV/CSA, Finance Compliance (SOX) & Legal Compliance (Privacy/Transparency) to align & improve governance & compliance policies/SOPs, & execute audit/inspection preparedness activities (e.g., risk-based storyboarding, control/procedure improvements, evidence readiness drills). - Act as escalation point & examiner-facing interface for IT portions of audits & health authority inspections; explain IT controls & CSV/CSA practices; coordinate IT evidence, storyboards & responses; & manage observations/CAPAs through remediation closure. From IT Council Project Portfolio: - Own & mature technology portfolio management practices that translate strategy into a clear, funded, executable roadmap with transparent status reporting for leadership decisions. - Oversee critical implementation programs & drive cross-functional alignment, escalation, dependency management, & delivery discipline. - Run portfolio intake, prioritization, categorization, risk/value assessment, dependency mapping, benefits tracking & portfolio reporting, with special focus on BLA, Inspection & Commercial Launch programs. From IT Governance: - Coordinate annual planning & IT Council/steering cadences, IT procurement coordination, & budget development/forecasting & BvA spend tracking. - Define, implement, & enforce IT governance across verticals through policies, SOPs, & fit-for-purpose processes, establishing ways of working (e.g., project/program governance, IT cadences, KPI/OKR framework) that improve performance & maturity. - Maintain dotted-line/matrixed governance for IT project managers, IT compliance, IT procurement & system validation staff to drive consistent execution, standard work, & audit/inspection readiness across systems & programs. Now Qualifications list items: each line. Let's list: - 15+ years of IT GxP (e.g. Part 11) compliance responsibility required - 12+ years directly managing or auditing IT operational processes - 10+ years developing, implementing & maintaining SDLC in alignment with principles of GAMP 5 - 8+ years of experience in a senior IT leadership position with demonstrated ability to lead compliance & project teams within the Biotech or Pharma industry. - Direct involvement as IT, compliance, or validation lead for at least one FDA or comparable health authority inspection, including examiner-facing preparation & response - Recent roles demonstrating expertise managing transparent IT project portfolios that enable effective steering committee oversight & portfolio health monitoring - Annual external audits of SOX IT General Control design & effectiveness, Segregation of Duties, & SSAE-18 SOC report reviews a plus - Multiple lab, scientific &/or financial software implementations (SDLC/Change Mgmt) as IT lead or compliance/validation lead. - Direct involvement as IT lead or compliance/validation lead in one or more Data Integrity or Computer System Assurance programs - Experience leading complex, cross-functional technology portfolios or commercial launch programs with dozens of concurrent projects, including roadmap governance, dependency tracking, executive reporting, vendor coordination, & delivery escalation - Education: Bachelor’s Degree in a Life Science or Computer Science. - Certifications