Associate Director, QC: Small Molecule Testing & Compliance

Vertex Pharmaceuticals Inc (US); Boston (MA); Hybride; USD 159 000 - 238 000; Plein temps

Avantages offerts par ce poste

Medical, dental and vision benefits

Generous paid time off

Educational assistance programs

Commuting subsidy

Matching charitable donations

401(k)

Résumé du poste

Vertex Pharmaceuticals Inc. seeks an Associate Director, QC Technical Services – Small Molecule to lead the external testing strategy and operational oversight for GMP release and stability testing.

You will manage relationships with contract labs and ensure compliant QC processes, while driving continuous improvement and regulatory support. The role requires proven leadership, strong QA background, and ability to coordinate with MS&T, Regulatory, and Quality Assurance to support uninterrupted

Qualifications

• Experience in biotech/pharma with analytical leadership in a cGMP environment.
• Proven ability to build and grow high-performance teams.
• Strong quality and compliance background with QC strategy development.
• Ability to develop contingency plans for adverse scenarios.

Responsabilités

• Provide oversight for GMP release and stability testing at external labs.
• Oversee contract testing labs ensuring timelines, quality, and quality agreements.
• Maintain compliant QC processes according to SOPs and guidance.
• Oversee external data review for OOS/OOE/OOT and trends.
• Lead KPI monitoring and CTL performance management.
• Manage quality events, CAPAs, deviations, and change controls.
• Collaborate cross-functionally with MS&T, AS&T, Regulatory, and QA.

Connaissances

cGMP testing

External labs mgmt

Quality systems

Regulatory support

Project management

Leadership

Stakeholder communication

Travel up to 20%

Formation

Master's degree

Bachelor's degree

Description du poste

Vertex Pharmaceuticals Inc. seeks an Associate Director, QC Technical Services – Small Molecule to lead the external testing strategy and operational oversight for GMP release and stability testing.

You will manage relationships with contract labs and ensure compliant QC processes, while driving continuous improvement and regulatory support. The role requires proven leadership, strong QA background, and ability to coordinate with MS&T, Regulatory, and Quality Assurance to support uninterrupted