QC Technical Services Director - External Labs & Compliance

Vertex Pharmaceuticals LLC; Boston (MA); Hybrid; USD 159,000 - 238,000; Full time

Job summary

Vertex Pharmaceuticals Incorporated seeks an Associate Director, QC Technical Services - Small Molecule to lead the external testing strategy for GMP release and stability. You will build and maintain partnerships with contract laboratories, ensure compliance with quality agreements, and provide strategic oversight to support uninterrupted commercial supply to patients.

You will lead KPI monitoring, oversee data review of OOS/OOE/OOT events, and collaborate across MS&T, Regulatory Affairs,

Qualifications

• Requires MSc and 8+ years in pharma/biopharma with 6 years of management responsibility
• Expertise in QC principles, concepts, industry practices, and standards
• Experience in method development, validation, and transfer for small molecules (LC/GC, dissolution, Karl Fischer, FTIR, XRPD)
• Audit/inspection interaction with health authorities
• Strong written and verbal communication and cross-functional leadership

Responsibilities

• Provide strategic and operational oversight for GMP release and stability testing at external laboratories.
• Oversee contract testing laboratories ensuring alignment with timelines and quality agreements.
• Ensure compliant execution of QC processes per SOPs and regulations.
• Oversee external data review for OOS/OOE/OOT and adverse trends.
• Lead KPI monitoring and CTL performance management.
• Prepare for audits/inspections at CMOs and contract labs.

Skills

Analytical leadership

Team leadership

Quality & compliance

Problem solving

Analytical chemistry

Project management

Communication skills

Leadership & collaboration

Education

Master degree

Bachelor degree

Tools

LC/GC

Dissolution

Karl Fischer

FTIR

XRPD

Job description

Vertex Pharmaceuticals Incorporated seeks an Associate Director, QC Technical Services - Small Molecule to lead the external testing strategy for GMP release and stability. You will build and maintain partnerships with contract laboratories, ensure compliance with quality agreements, and provide strategic oversight to support uninterrupted commercial supply to patients.

You will lead KPI monitoring, oversee data review of OOS/OOE/OOT events, and collaborate across MS&T, Regulatory Affairs,