R&D Quality Director: GLP, Biomarkers & IVD Oversight

Vertex Pharmaceuticals Incorporated; Boston (MA); Hybrid; USD 215,000 - 322,000; Full time

Benefits offered by this job

Annual bonus

Stock equity

Comprehensive benefits

Paid time off

Commuting subsidy

Student loan repayment

Job summary

Vertex Pharmaceuticals Incorporated seeks a senior leader to own end-to-end quality assurance strategy for proactive, risk-informed oversight of R&D, GLP, Biomarker, and IVD activities. You will guide data integrity, regulatory alignment, and vendor governance while mentoring the QA team.

The role demands high-level collaboration with Research, Biomarker Development, and Diagnostics, ensuring compliance and readiness for inspections in a hybrid work model from Boston.

Qualifications

• Strong knowledge of quality systems and regulatory expectations for R&D, GLP, and IVD activities.
• Proven track record leading quality oversight across research, preclinical, and clinical programs.
• Experience ensuring data integrity and regulatory compliance through risk-based strategies.

Responsibilities

• Provide strategic leadership for QA strategy across Vertex research and development.
• Oversee adherence to GLP, GxP, and other regulatory requirements for studies and vendor activities.
• Lead quality issue identification, remediation, and governance across R&D workflows.
• Communicate quality health metrics to senior leadership and relevant forums.
• Chair governance meetings and support inspection readiness activities.
• Mentor and develop QA staff to align with regulatory expectations.

Skills

Quality leadership

Regulatory compliance

GxP knowledge

Cross-functional leadership

R&D quality

Education

M.S. (or equivalent degree)

B.S. in a scientific or allied health field

Job description

Vertex Pharmaceuticals Incorporated seeks a senior leader to own end-to-end quality assurance strategy for proactive, risk-informed oversight of R&D, GLP, Biomarker, and IVD activities. You will guide data integrity, regulatory alignment, and vendor governance while mentoring the QA team.

The role demands high-level collaboration with Research, Biomarker Development, and Diagnostics, ensuring compliance and readiness for inspections in a hybrid work model from Boston.