Head of QC External Testing & Stability (Small Molecules)

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

Job summary

Vertex Inc. seeks an Associate Director, QC Technical Services - Small Molecule to lead a GMP release and stability testing program across external laboratories supporting commercial products.

You will drive strategic oversight, ensure quality, and maintain performance metrics to support uninterrupted patient supply. You will report to the Senior Director of QC Operations and Stability and collaborate with cross-functional teams to improve QC systems and testing efficiency in a global, hybrid

Qualifications

• Master degree and 8+ years, or Bachelor’s and 10+ years in pharma/biopharma with 6+ years in management.
• Expertise in QC principles, concepts, industry practices, and standards.
• Experience in method development, validation, and transfer for small molecule analyses (LC/GC, dissolution, Karl Fischer, FTIR, XRPD).

Responsibilities

• Provide strategic and operational oversight for GMP release and stability testing at external labs.
• Oversee contract testing labs ensuring timelines, quality standards and QA agreements.
• Ensure compliant QC processes per SOPs and regulatory guidance.
• Oversee data review for OOS/OOE/OTT and trends; escalate as needed.
• Lead KPI monitoring and CTL performance for reliable testing.
• Manage quality events: change controls, deviations, CAPAs and timely escalation.
• Collaborate with MS&T, AS&T, Supply Management, Regulatory, PM, QA.
• Provide QC input to regulatory submissions.
• Prepare for audits/inspections at CMOs and labs.
• Build strong internal and external stakeholder relationships.

Skills

Biotech/pharma experience

Analytical leadership

Quality & compliance

Problem solving

Analytical chemistry

Project management

Communication skills

Leadership

Travel 20%

Education

Master's degree in relevant field

Bachelor's degree + 10+ years

QC principles & standards

Job description

Vertex Inc. seeks an Associate Director, QC Technical Services - Small Molecule to lead a GMP release and stability testing program across external laboratories supporting commercial products.

You will drive strategic oversight, ensure quality, and maintain performance metrics to support uninterrupted patient supply. You will report to the Senior Director of QC Operations and Stability and collaborate with cross-functional teams to improve QC systems and testing efficiency in a global, hybrid