Associate Director, QC: Small Molecule Testing & Compliance

Vertex Pharmaceuticals Inc (US)

Boston (MA)

Hybrid

USD 159,000 - 238,000

Full time

5 days ago
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Benefits offered by this job

Medical, dental and vision benefits
Generous paid time off
Educational assistance programs
Commuting subsidy
Matching charitable donations
401(k)

Job summary

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.

Responsibilities

  • 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.

Skills

cGMP testing
External labs mgmt
Quality systems
Regulatory support
Project management
Leadership
Stakeholder communication
Travel up to 20%

Education

Master's degree
Bachelor's degree

Job description

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

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