Analytical Quality Assurance, Associate Director

Vertex Pharmaceuticals Incorporated; Boston (MA); On-site; USD 140,880 - 234,800; Full time

Benefits offered by this job

Annual bonus

Equity awards

Job summary

Vertex Pharmaceuticals Incorporated is seeking an Associate Director of QA for QC to oversee quality activities across analytical development, validation, and transfer for Cell & Gene programs. The role emphasizes QA leadership, regulatory compliance, and collaboration with internal labs and external contract testing laboratories.

Responsibilities include leading OOS/OOT investigations, CAPA programs, and adherence to GMP/GxP standards while integrating digital tools (MES/LIMS/eQMS) for data

Qualifications

• In-depth global regulatory agency and technical knowledge and experience across GXP QA and QC activities in cell therapies.
• Broad understanding of regulatory environments including quality systems, compliance and GMP regulations.
• Experience with platforms such as MES, LIMS, eQMS, data visualization tools, and advanced analytics is preferred.

Responsibilities

• Analytical Lifecycle Management: QA SME for QC domain; drive quality culture; lead QA reviews of analytical development, qualification and validation; oversee transfer activities and stability programs.
• Compliance & Investigations: RCA and CAPA for OOS/OOT; QA review of deviation investigations and change control.
• Contractor Oversight: QA oversight for internal QC labs and external contract testing labs; draft Quality Agreements.
• Digital & AI: understand digital quality systems; use MES/LIMS/eQMS and analytics to improve quality oversight and decision-making.
• Quality Management Systems: use eQMS for change controls and deviations; support audits; assist in SOPs and continuous improvement.

Skills

GXP QA

QC oversight

Regulatory compliance

Data analytics

LEAN / Six Sigma

Communication skills

Problem solving

Education

Master's degree in science

Ph.D. preferred

Tools

MES

LIMS

eQMS

Data visualization tools

Job description

Overview

The Associate Director (AD) Quality Assurance (QA for QC) is an advanced technical resource responsible for quality oversight of Quality Control and analytical development activities for Cell & Gene programs. Activities include release analytical testing, stability testing, and QA support for deviations and out of specification investigations. The role provides QA oversight of technical analytical method validations and analytical transfer activities internally and with CDMOs through the program life cycle management.

Responsibilities

• Analytical Lifecycle Management: Serve as a Quality Assurance Subject Matter Expert for the QC domain and drive a culture of quality to assure compliance with FDA, EMA, and internal SOPs. Lead QA reviews and approvals 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 and assist in responses to regulatory questions.
• Compliance & Investigations: Ensure proper root cause analysis (RCA) and Corrective and Preventive Actions (CAPA) for Out of Specification (OOS) and Out of Trend (OOT) results. Perform or lead QA review and approval of QC-associated documentation including deviation investigations, OOS, OOT, and change control.
• Contractor Oversight: Execute QA operational oversight for internal QC laboratories and external contract testing laboratories. Draft and enforce 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. Use platforms such as MES, LIMS, eQMS, data visualization tools, and advanced analytics to perform quality oversight.
• Quality Management Systems (QMS): Utilize eQMS platforms for change controls and deviation tracking. Act as SME during audits and inspections by regulatory agencies. Support or lead QA risk management activities, including mitigation plans and execution. Support development of Vertex quality systems and processes; draft/revise SOPs, policies, and work instructions. Identify, facilitate, and lead continuous improvement efforts. Ensure development of quality metrics at contract organizations to 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 environments 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 in/running internal analytical labs and collaborating with external test labs.
• Experience in analytical method development.
• Ability to lead improvement projects with Root Cause Analysis, data analytics, and operational excellence approaches such as LEAN, DMAIC, Six Sigma.
• Excellent communication skills with a proven track record of influencing and 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).
• 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 - $234,800

Disclosure Statement

The range provided is a base salary estimate for the position at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary will be based on skills, competencies, experience, and other factors permitted by law. At Vertex, total rewards include benefits designed to support career, financial, family, and wellbeing goals, including medical, dental, and vision benefits, paid time off, educational assistance programs, commuting subsidy, matching charitable donations, and 401(k) plans.

Flex Designation

On-Site Designated

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 may be changed at any time per Vertex policy.

#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 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 by 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. Applicants requiring an accommodation for the hiring process may contact the recruiter or Talent Acquisition at [e-mail].