Job Description
General Summary:
The Associate Director (AD) Quality Assurance (QA for QC) is an advanced technical resource in the principles and application of quality assurance and compliance. This role is responsible for the quality oversight of Quality Control and analytical development activities of Cell & Gene programs. Activities in scope of this role include release analytical testing, stability testing, and QA support for deviations and out of specification investigations. The role will have QA oversight of technical analytical method validations and analytical transfer activities internally /CDMOs through the program life cycle management.
Key Duties and Responsibilities:
Analytical Lifecycle Management:
- Serve as a Quality Assurance Subject Matter Expert for in QC domain and drive culture of quality to assure compliance with FDA, EMA, and internal SOPs.
- Lead QA review and approval of analytical development, qualification and validation as well as analytical technical transfer activities
- Ensure stability program is conducted in compliance with established protocols and applicable regulations.
- Review relevant sections of regulatory submissions; Assist in responses to regulatory questions.
Compliance & Investigations
- Ensuring proper root cause analysis (RCA) and Corrective and Preventive Actions (CAPA) for Out of Specification (OOS) and Out of Trend (OOT) results
- Perform/lead QA review and approval of QC associated documentation including deviation investigations, OOS, OOT and change control.
CTO & CMO Management:
- Execute QA operational oversight for internal QC laboratories and external contract testing laboratories.
- Drafts and enforces Quality Agreements between Contract Test Labs and Vertex.
Digital & Artificial Intelligence
- Demonstrated understanding of digital quality systems, data management, automation, and emerging AI technologies within regulated GxP environments.
- Experience leveraging data analytics, digital tools, and AI-enabled solutions to improve quality oversight, operational efficiency, and decision-making.
- Responsible for using platforms such as MES, LIMS, eQMS, data visualization tools, and advanced analytics to perform Quality oversight.
Quality Management Systems (QMS): Utilizing eQMS platforms for change controls and deviation tracking
- Acting as the subject matter expert (SME) during audits and inspections regulatory agencies
- Support/lead QA risk management activities, including mitigation plans and associated execution.
- Support development of Vertex quality systems and processes, draft/revise SOPs, policies and work instructions.
- Identify, facilitate, and/or lead continuous improvement efforts
- Ensure development of quality metrics at the contract organizations that support excellence in quality systems
Knowledge and Skills:
- In-depth global regulatory agency and technical knowledge and experience across GXP QA and QC activities in cell therapies
- Broad understanding of regulatory environment including quality systems, compliance and GMP regulations.
- Experience with platforms such as MES, LIMS, eQMS, data visualization tools, and advanced analytics is preferred.
- Prior experience working /running internal analytical lab and working with external Test labs.
- Experience in analytical method development
- Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.
- Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.
- Critical Thinking and Problem Solving skills
Education and Experience:
- Master's degree in a scientific or allied health field (or equivalent degree)
- Ph.D. preferred
- 8+ years of experience, or the equivalent combination of education and experience in a regulated pharmaceutical environment.
Other Requirements:
- Up to 15% travel
Pay Range:
$156,600 - $234,800Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
On-Site DesignatedFlex Eligibility Status:
In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Onsite
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]
Skills Required
- Master's degree in a scientific or allied health field (or equivalent)
- Ph.D.
- 8+ years experience in a regulated pharmaceutical environment (or equivalent combination of education and experience)
- In-depth GxP QA and QC experience in cell therapies
- Broad understanding of regulatory environment including quality systems, compliance, and GMP regulations
- Demonstrated understanding of digital quality systems, data management, automation, and emerging AI technologies within regulated GxP environments
- Experience with platforms such as MES, LIMS, eQMS, data visualization tools, and advanced analytics
- Prior experience running internal analytical laboratories and working with external contract testing laboratories/CMOs
- Experience in analytical method development, qualification, and validation and analytical transfer activities
- Experience leading root cause analysis (RCA), corrective and preventive actions (CAPA), OOS/OOT investigations, change control, and deviation management
- Experience drafting and enforcing Quality Agreements with contract test labs and providing QA oversight of vendors/CMOs
- Experience supporting/leading audits and inspections as QA subject matter expert
- Operational excellence experience (e.g., Lean, DMAIC, Six Sigma) and data analytics to drive improvement projects
- Excellent communication, influencing skills, and ability to promote a culture of quality
Vertex Pharmaceuticals Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Vertex Pharmaceuticals and has not been reviewed or approved by Vertex Pharmaceuticals.
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Parental & Family Support — Policies provide 12 weeks of 100% paid bonding leave for all U.S. parents with additional fully paid time for birth parents. Family-forming supports include adoption and surrogacy assistance, fertility options like IVF and egg cryopreservation, breast‑milk shipping, subsidized childcare, backup care, and a DCFSA match.
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Leave & Time Off Breadth — Time off includes roughly four weeks of vacation, 13 holidays, sick time, and two companywide shutdowns (summer and year‑end). Some roles also include flexible or unlimited time off and paid volunteer time.
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Retirement Support — Programs include a 401(k) plan with employer contributions and an employee stock purchase plan. Filings describe employer contributions occurring in company stock, supporting long‑term ownership.
Vertex Pharmaceuticals Insights
What We Do
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston’s Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 3,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development. Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards.
