Analytical Quality Assurance, Associate Director

Vertex Pharmaceuticals Inc (US); Boston (MA); On-site; USD 156,600 - 234,800; Full time

Benefits offered by this job

Medical, dental, vision coverage

Generous PTO and shutdowns

Educational assistance

Commuting subsidy

401(k) with company match

Job summary

Vertex Pharmaceuticals Inc. is seeking an Associate Director of Quality Assurance to oversee QA across QC and analytical development for Cell & Gene programs.

The role drives QA oversight from method validation to transfer, stability testing, and regulatory submissions to ensure compliance with FDA/EMA and internal SOPs. The AD QA will act as SME for QC activities, lead CAPA, deviation, and change control processes, and leverage MES, LIMS, and eQMS to boost efficiency.

Qualifications

• Master’s degree in a scientific or allied health field; Ph.D. preferred.
• 8+ years of regulated pharmaceutical experience or equivalent mix of education and experience.
• In-depth knowledge of GxP QA and QC activities in cell therapies and GMP regulations.
• Experience with MES, LIMS, and eQMS systems and data analytics.
• Experience running internal analytical labs and collaborating with external test labs.
• Proficiency in analytical method development.
• Strong Root Cause Analysis, data analytics, and Lean Six Sigma frameworks.
• Excellent communication and problem-solving skills.

Responsibilities

• Act as QA SME for QC, leading QA review of development, qualification, and validation activities.
• Ensure stability programs comply with protocols and regulations.
• Review regulatory submission sections and assist in regulatory responses.
• Conduct RCA and manage CAPA for OOS/OOT results.
• Lead QA review of deviation investigations, OOS, OOT, and change controls.
• Provide QA oversight for internal and contract testing labs.
• Draft and enforce Quality Agreements with contract labs and Vertex.
• Leverage MES, LIMS, eQMS, and data analytics to improve quality oversight.
• Serve as SME during audits and inspections; support QA risk management.
• Support development of Vertex quality systems and SOPs.

Skills

Quality Assurance

GxP QA

Analytical method development

Data analytics

Regulatory submissions

Lean Six Sigma

Root Cause Analysis

Education

Master’s degree in science

Ph.D. preferred

Tools

MES

LIMS

eQMS

Data visualization

Job description

Job Summary

The Associate Director (AD) Quality Assurance (QA) is a senior technical resource responsible for overseeing quality assurance and compliance across all Quality Control and analytical development activities within Vertex’s Cell & Gene programs. The role drives QA oversight from analytical method validation to analytical transfer, stability testing, and regulatory submissions, ensuring adherence to FDA, EMA, and internal SOPs.

Key Responsibilities

• Act as the QA Subject Matter Expert for QC, leading QA review and approval of analytical development, qualification, and validation activities.
• Ensure stability programs are performed according to protocols and regulatory requirements.
• Review regulatory submission sections and assist in responses to regulatory questions.
• Conduct root cause analysis (RCA) and manage corrective & preventive actions (CAPA) for OOS/OOT results.
• Lead QA review of deviation investigations, OOS, OOT, and change control documentation.
• Provide QA operational oversight for internal QC laboratories and external contract testing laboratories.
• Draft and enforce Quality Agreements with contract test labs and Vertex.
• Leverage digital quality systems (MES, LIMS, eQMS), data analytics, and AI-enabled solutions to improve quality oversight and operational efficiency.
• Serve as SME during audits and inspections, support QA risk management, and lead continuous improvement initiatives.
• Support development of Vertex quality systems and processes, drafting/revising SOPs, policies, and work instructions.
• Establish quality metrics for contract organizations to support excellence in quality systems.

Qualifications

• Master’s degree in a scientific or allied health field (or equivalent) – Ph.D. preferred.
• 8+ years of regulated pharmaceutical experience, or equivalent mix of education and experience.
• In-depth knowledge of GxP QA and QC activities in cell therapies and GMP regulations.
• Experience with MES, LIMS, eQMS, data visualization, and advanced analytics.
• Experience running internal analytical labs and working with external test labs.
• Proficiency in analytical method development.
• Strong understanding of Root Cause Analysis, data analytics, and operational excellence frameworks (Lean, DMAIC, Six Sigma).
• Excellent communication, influencing, and problem‑solving skills.

Other Requirements

• Up to 15% travel.
• On‑site designated flex scheduling – five days per week on site with ad‑hoc flexibility.

Pay Range

$156,600 – $234,800. Eligible for annual bonus, equity awards, and potential overtime pay in accordance with federal and state laws.

Benefits

• Medical, dental, and vision coverage.
• Generous paid time off, including annual company shutdowns.
• Educational assistance and student loan repayment programs.
• Commuting subsidy and charitable donation matching.
• 401(k) plan with company match.

Equal Employment Opportunity Statement

Vertex is a global biotechnology company that is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants. Vertex will make reasonable accommodations for qualified individuals with disabilities in accordance with applicable law.