Strategic QA Lead, Analytical Development & QC

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

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