Vice President, Quality Assurance
LabConnect · Johnson City, TN · 1 mo ago
RemoteRemoteQuality AssuranceFull-time
We need to output HTML fragment with sections: h3 headings for sections present with real content. Must not repeat job title. Must not include Job ID etc. Remove boilerplate like EEO, legal, application instructions, etc. Must preserve substantive info.
We need to identify sections: Overview (maybe not needed as heading? Could be "About the role"? The posting includes Overview and Summary. We can treat "Overview" as maybe "About the role"? But instruction: use h3 for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we need to map content to these headings if present. The posting includes Overview, Summary, Responsibilities, Education and Qualifications, Required Skills, etc. Also includes "Some of the Perks our LabConnectors Love:" which is Benefits. Also includes location note: "This position is ideally suited for candidates within commuting distance to Johnson City, TN or in the Eastern US time zone." That could be Schedule? Not exactly schedule. Could be location; but we only create Schedule if posting actually states schedule. It doesn't mention schedule/hours. So we omit Schedule. Pay: not mentioned. Benefits: we have perks list. So we create Benefits section.
Qualifications: Education and Qualifications section.
Skills: Required Skills section.
Responsibilities: we have a Responsibilities list.
Also maybe "About the role": could combine Overview and Summary. We'll create About the role section with overview+summary.
We must not include headings with filler. Ensure we only include sections with real content.
We need to use
- for any list of duties/requirements/benefits. So for Responsibilities list, we need to convert the bullet points into
- . The responsibilities are listed as sentences after "Responsibilities:" each starting with a verb. We'll extract each line.
Similarly for Required Skills list: many bullet-like sentences. We'll convert to list.
For Benefits: list of perks.
We need to preserve all substantive information; do not invent or summarize away detail. So we must include all details from those sections.
We must remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. So we need to cut out the EEO statement, GDPR notice, contact email/phone, etc. Also remove the "Join our team..." paragraph? That's somewhat promotional but maybe considered boilerplate? It's not EEO but it's a call to action; might be considered application encouragement. The instruction says remove application instructions. The "Join our team..." is not exactly instruction but could be considered promotional; but we might keep it as part of overview? Safer to remove it as it's not substantive job description. Also remove "Some of the Perks our LabConnectors Love:" heading? We'll keep benefits but we can keep the list.
We also need to remove duplicated lines.
Let's extract content.
Original text:
Overview LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world. We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.
Summary: The Vice President, Quality Assurance is responsible for building and leading an effective team globally and ensuring data privacy, quality oversight and regulatory compliance. He/she is accountable for the quality oversight of all GxP activities and performance of the QMS. They lead and collaborate with other functions to achieve organizational quality standards and GxP compliance, set quality goals and standards for LC, and oversee the Quality Assurance and Quality Control function. This is a pivotal role that drives quality initiatives, cross collaboration, and continuous improvement to promote quality culture and excellence. This position is ideally suited for candidates within commuting distance to Johnson City, TN or in the Eastern US time zone.
General responsibilities include but are not limited to:
Responsibilities:
Leads and directs Operations, Quality and other functions on quality matters, escalations and regulatory requirements.
Partners with all functions for managing, informing and driving a culture of quality in the entire organization.
Serves as Data Privacy Officer for the organization.
Provides oversight of quality assurance and quality control activities.
Including identifying and reporting on key Quality metrics to measure performance and drive excellence/RFT culture.
Supports an audit program consisting of vendor, client and internal audits; provides oversight of the vendor qualification and monitoring including appropriate CAPA and issue resolution.
Leads a global quality team to ensure adequate resourcing, expertise and processes that govern LC operations and comply with application regulations and client agreements.
Creates annual strategic Quality Plan.
Provides regulatory and compliance risk review of contractual negotiations.
Ensures clarity on Quality agreements with Clients.
Serves as quality and regulatory advisor to partners and clients where applicable.
Represents LC Quality at various forums.
Participates in and provides quality guidance for strategic projects and plans.
Ensures a training program that provides LC personnel engaged in GxP activities are adequately trained, including annual retraining.
Accountable for the Quality Management System and all applicable quality processes and procedures.
Maintains a working knowledge of regulatory and industry requirements and best practices and implements as appropriate.
Performs other related duties and tasks as necessary or as assigned.
Education and Qualifications:
Bachelor's degree from four-year college or university with 12-15 years related experience and/or training; or equivalent combination of education and experience.
10+ years of progressive experience in building and leading global teams in regulated environments (biotech, Central labs and /or Pharma companies) with a specific focus on Quality.
Proven experience managing FDA inspections, client audits and quality oversight across drug development, approval and post market (GxPs).
Strongly Preferred:
Experience in clinical trials, clinical laboratory, FDA 21CRF11/GCP, GxP.
Certifications and thorough understanding of applicable global regulations.
Veeva vault experience highly desired.
Required Skills
Proven leadership/supervisory ability and experience.
Ability to strategize and solve problems and have strong leadership skills.
Strong analytical skills and proven ability to work effectively with the CQO as a strategic partner.
Ability to travel as needed/requested.
Global work experience with teams and clients across cultures and time zones.
Ability to adhere to established timelines, processes and procedures.
Excellent attention to detail.
Strong planning and problem-solving skills.
Self-motivation and ability to work well independently, as well as using a collaborative team approach.
Excels at adapting to changing environments and requirements.
Ability to make quick and well-thought-out decisions.
Excellent organization and time management skills, communication, multitasking, interpersonal and listening skills.
Business acumen to drive a quality culture while meeting and advancing business short term and long-term goals.
Proficient in Microsoft Word, Excel, and database software.
Language Ability: Ability to read, write and comprehend internal and external correspondence, meeting agendas and meeting notes.
Mathematical Ability: Ability to apply simple mathematical skills and abstract thinking in a logical and organized manner.
Reasoning Ability: Ability to solve practical problems, investigate issues, draw correct and logical conclusions; the ability to understand instructions, mathematical and diagrammatic representations of data in both an abstract and concrete manner.
Computer Skills: To perform this job successfully, an individual must have advanced working knowledge of Microsoft Office applications and proficiency in finance software and technology.
Supervisory Responsibilities: Management and Specialist levels
Work Environment: The noise level in the work environment is usually moderate.
Physical Demands: While performing the duties of this job, the employee is regularly required to sit. The employee is frequently required to talk or hear. The employee is occasionally required to stand; walk and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus.
This job description should not be construed to imply that these requirements are the exclusive standards of the position. Incumbents will follow any other instructions and perform other related duties as may be required by their supervisor.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.
Some of the Perks our LabConnectors Love:
Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility)
Health Benefits beginning on date of hire
PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community
Short and Long-Term Disability, Life Insurance, and AD&D
We celebrate our differences, which enriches our culture! In addition to great perks and challenging work assignments, we invest in our people with career growth opportunities, globally.
We believe in a friendly and collaborative environment with open lines of communication.
While living out our values of People First, Quality Focused, Customer Centered, Technology Driven, and Accountability Always.
We are proud to be an Equal Employment Opportunity Employer and value the diversity of our workforce. We do not discriminate on the basis of race, gender, age, disability, religion, sexual orientation, or any other protected characteristic. To learn more about equal employment opportunity, please view the posters here: https://www.dol.gov/agencies/whd/posters
LabConnect also prioritizes the privacy and security of your personal data. All candidate information is handled in accordance with General Data Protection Regulation (GDPR). To learn more, please review our Privacy Notice on our website, by navigating to https://www.labconnect.com/
If you need assistance to complete your job application, search for a job opening, or submit an online application at LabConnect, please email talent@labconnect.com or call +1 (423) 722-3155.
We need to strip out EEO, GDPR, contact info, etc. Also remove the "We celebrate our differences..." paragraph? That's cultural statement; maybe keep as part of benefits? It's not a perk per se but could be considered culture. Might be okay to keep but it's not a list item. However instruction: Use
- for any list of duties/requirements/benefits, and
for prose. So we can keep prose paragraphs in
. The cultural statements could be prose. But we should remove the EEO line and GDPR line and contact info. Also remove the "We are proud to be an Equal Employment Opportunity Employer..." line and the link. Also remove "LabConnect also prioritizes the privacy..." line and link. Also remove the contact email/phone line. Also remove the "We celebrate our differences..."? It's not EEO but it's a value statement; could be kept as prose. However it's somewhat generic; but not prohibited. I'd keep it as prose maybe under Benefits? But we already have Benefits list; we could add a
after list describing culture. However instruction: Prefer a few substantive sections over many thin ones. So maybe we incorporate that into Benefits section as prose after list. But we need to ensure we don't include filler like "We believe in a friendly and collaborative environment..." That's also generic but could be kept. Nevertheless, we need to produce HTML fragment. Let's craft sections:
About the role
Overview text + Summary text (excluding location? location maybe part of schedule but we don't have schedule section; we could include location in About the role as prose). We'll include the overview paragraph and summary paragraph (including the location sentence). Ensure we keep all info. Overview paragraph: "LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world. We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team
- for any list of duties/requirements/benefits, and
- . The responsibilities are listed as sentences after "Responsibilities:" each starting with a verb. We'll extract each line.
Similarly for Required Skills list: many bullet-like sentences. We'll convert to list.
For Benefits: list of perks.
We need to preserve all substantive information; do not invent or summarize away detail. So we must include all details from those sections.
We must remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. So we need to cut out the EEO statement, GDPR notice, contact email/phone, etc. Also remove the "Join our team..." paragraph? That's somewhat promotional but maybe considered boilerplate? It's not EEO but it's a call to action; might be considered application encouragement. The instruction says remove application instructions. The "Join our team..." is not exactly instruction but could be considered promotional; but we might keep it as part of overview? Safer to remove it as it's not substantive job description. Also remove "Some of the Perks our LabConnectors Love:" heading? We'll keep benefits but we can keep the list.
We also need to remove duplicated lines.
Let's extract content.
Original text:
Overview LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world. We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.
Summary: The Vice President, Quality Assurance is responsible for building and leading an effective team globally and ensuring data privacy, quality oversight and regulatory compliance. He/she is accountable for the quality oversight of all GxP activities and performance of the QMS. They lead and collaborate with other functions to achieve organizational quality standards and GxP compliance, set quality goals and standards for LC, and oversee the Quality Assurance and Quality Control function. This is a pivotal role that drives quality initiatives, cross collaboration, and continuous improvement to promote quality culture and excellence. This position is ideally suited for candidates within commuting distance to Johnson City, TN or in the Eastern US time zone.
General responsibilities include but are not limited to:
Responsibilities:
Leads and directs Operations, Quality and other functions on quality matters, escalations and regulatory requirements.
Partners with all functions for managing, informing and driving a culture of quality in the entire organization.
Serves as Data Privacy Officer for the organization.
Provides oversight of quality assurance and quality control activities.
Including identifying and reporting on key Quality metrics to measure performance and drive excellence/RFT culture.
Supports an audit program consisting of vendor, client and internal audits; provides oversight of the vendor qualification and monitoring including appropriate CAPA and issue resolution.
Leads a global quality team to ensure adequate resourcing, expertise and processes that govern LC operations and comply with application regulations and client agreements.
Creates annual strategic Quality Plan.
Provides regulatory and compliance risk review of contractual negotiations.
Ensures clarity on Quality agreements with Clients.
Serves as quality and regulatory advisor to partners and clients where applicable.
Represents LC Quality at various forums.
Participates in and provides quality guidance for strategic projects and plans.
Ensures a training program that provides LC personnel engaged in GxP activities are adequately trained, including annual retraining.
Accountable for the Quality Management System and all applicable quality processes and procedures.
Maintains a working knowledge of regulatory and industry requirements and best practices and implements as appropriate.
Performs other related duties and tasks as necessary or as assigned.
Education and Qualifications:
Bachelor's degree from four-year college or university with 12-15 years related experience and/or training; or equivalent combination of education and experience.
10+ years of progressive experience in building and leading global teams in regulated environments (biotech, Central labs and /or Pharma companies) with a specific focus on Quality.
Proven experience managing FDA inspections, client audits and quality oversight across drug development, approval and post market (GxPs).
Strongly Preferred:
Experience in clinical trials, clinical laboratory, FDA 21CRF11/GCP, GxP.
Certifications and thorough understanding of applicable global regulations.
Veeva vault experience highly desired.
Required Skills
Proven leadership/supervisory ability and experience.
Ability to strategize and solve problems and have strong leadership skills.
Strong analytical skills and proven ability to work effectively with the CQO as a strategic partner.
Ability to travel as needed/requested.
Global work experience with teams and clients across cultures and time zones.
Ability to adhere to established timelines, processes and procedures.
Excellent attention to detail.
Strong planning and problem-solving skills.
Self-motivation and ability to work well independently, as well as using a collaborative team approach.
Excels at adapting to changing environments and requirements.
Ability to make quick and well-thought-out decisions.
Excellent organization and time management skills, communication, multitasking, interpersonal and listening skills.
Business acumen to drive a quality culture while meeting and advancing business short term and long-term goals.
Proficient in Microsoft Word, Excel, and database software.
Language Ability: Ability to read, write and comprehend internal and external correspondence, meeting agendas and meeting notes.
Mathematical Ability: Ability to apply simple mathematical skills and abstract thinking in a logical and organized manner.
Reasoning Ability: Ability to solve practical problems, investigate issues, draw correct and logical conclusions; the ability to understand instructions, mathematical and diagrammatic representations of data in both an abstract and concrete manner.
Computer Skills: To perform this job successfully, an individual must have advanced working knowledge of Microsoft Office applications and proficiency in finance software and technology.
Supervisory Responsibilities: Management and Specialist levels
Work Environment: The noise level in the work environment is usually moderate.
Physical Demands: While performing the duties of this job, the employee is regularly required to sit. The employee is frequently required to talk or hear. The employee is occasionally required to stand; walk and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus.
This job description should not be construed to imply that these requirements are the exclusive standards of the position. Incumbents will follow any other instructions and perform other related duties as may be required by their supervisor.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.
Some of the Perks our LabConnectors Love:
Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility)
Health Benefits beginning on date of hire
PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community
Short and Long-Term Disability, Life Insurance, and AD&D
We celebrate our differences, which enriches our culture! In addition to great perks and challenging work assignments, we invest in our people with career growth opportunities, globally.
We believe in a friendly and collaborative environment with open lines of communication.
While living out our values of People First, Quality Focused, Customer Centered, Technology Driven, and Accountability Always.
We are proud to be an Equal Employment Opportunity Employer and value the diversity of our workforce. We do not discriminate on the basis of race, gender, age, disability, religion, sexual orientation, or any other protected characteristic. To learn more about equal employment opportunity, please view the posters here: https://www.dol.gov/agencies/whd/posters
LabConnect also prioritizes the privacy and security of your personal data. All candidate information is handled in accordance with General Data Protection Regulation (GDPR). To learn more, please review our Privacy Notice on our website, by navigating to https://www.labconnect.com/
If you need assistance to complete your job application, search for a job opening, or submit an online application at LabConnect, please email talent@labconnect.com or call +1 (423) 722-3155.
We need to strip out EEO, GDPR, contact info, etc. Also remove the "We celebrate our differences..." paragraph? That's cultural statement; maybe keep as part of benefits? It's not a perk per se but could be considered culture. Might be okay to keep but it's not a list item. However instruction: Use