Associate Director, QC Tech Services – Small Molecules

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

Job summary

Vertex Pharmaceuticals is seeking an Associate Director, QC Technical Services - Small Molecule. This role leads the external QC testing services for GMP release and stability, driving compliance and continuous improvement across contract labs.

You will oversee performance metrics, data reviews, and QA processes, ensuring uninterrupted commercial supply and robust regulatory support. This hybrid role requires strategic leadership and strong collaboration across MS&T, Regulatory, and Quality

Qualifications

• Requires Master’s degree with 8+ years in pharmaceutical/biopharmaceutical industry and 6+ years in increasing management responsibility.
• Expertise in QC principles, concepts, industry practices, and standards.
• Experience with method development, validation, and transfer of analytical methods for small molecules.

Responsibilities

• Provide strategic and operational oversight for GMP release and stability testing at external labs.
• Oversee contract testing laboratories and ensure timelines, quality standards and quality agreements.
• Ensure compliant execution of QC processes per SOPs, policies, and guidance.
• Oversee external data review for OOS, OOE, OOT and adverse trends.
• Lead KPI monitoring and CTL performance management for reliable testing operations.
• Manage quality events including deviations, CAPAs, and change controls.
• Collaborate with MS&T, AS&T, Supply Management, Regulatory Affairs, and QA.

Skills

GMP release testing

QC leadership

Regulatory compliance

Analytical chemistry

Cross-functional collaboration

Project management

Quality systems

Documentation

External labs oversight

Travel up to 20%

Education

Master's degree + 8+ years

Bachelor's + 10+ years with 6+ years mgmt

QC principles & industry practices

Regulatory knowledge (ICH CFR FDA)

Audits/inspections with health authorities

Job description

Vertex Pharmaceuticals is seeking an Associate Director, QC Technical Services - Small Molecule. This role leads the external QC testing services for GMP release and stability, driving compliance and continuous improvement across contract labs.

You will oversee performance metrics, data reviews, and QA processes, ensuring uninterrupted commercial supply and robust regulatory support. This hybrid role requires strategic leadership and strong collaboration across MS&T, Regulatory, and Quality