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:

Disclosure Statement:

Flex Designation:

Flex 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]