Senior QC Strategy Lead - Small Molecules (Hybrid)

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

Benefits offered by this job

Hybrid work model

On-site option

Annual bonus

Equity awards

Paid time off

Job summary

Vertex Pharmaceuticals LLC seeks an Associate Director, QC Technical Services – Small Molecule, to lead a team responsible for GMP release and stability testing at external laboratories supporting commercial programs. You will drive compliance, performance metrics, and cross-functional collaboration to ensure uninterrupted supply.

The role requires a strong analytical chemistry background, hands-on leadership, and the ability to manage complex projects in a fast-moving biopharma environment.

Qualifications

• Requires Master’s degree with 8+ years, or Bachelor’s with 10+ years in pharmaceutical/biopharmaceutical industry with increasing management responsibility.
• Expertise in QC principles, industry standards, and cGMP compliance for small molecule testing.
• Experience in audits/inspections with health authorities.
• Ability to work independently and lead in a virtual environment with external partners.
• Excellent written and verbal communication skills.

Responsibilities

• Provide strategic and operational oversight for GMP release and stability testing at external labs.
• Oversee contract testing labs to ensure timelines, quality, and quality agreements.
• Ensure compliant execution of QC processes per SOPs and regulatory guidance.
• Oversee data review of OOS/OOE/OOT and adverse trends with proper escalation.
• Lead KPI monitoring, CTL performance, and quality event management including CAPAs.
• Collaborate with MS&T, AS&T, Supply Management, Regulatory, PM, and QA for program support.
• Provide QC input to regulatory submissions and readiness for audits/inspections.
• Develop and strengthen internal quality systems for the technical services function.

Skills

Analytical chemistry

cGMP testing

Leadership

Project management

Quality assurance

Regulatory knowledge

Vendor/external labs mgmt

Cross-functional collaboration

Communication

Education

Master's degree in pharmaceutical/biotech

Bachelor's degree in pharmaceutical/biotech

Tools

LC/GC chromatography

Dissolution

Karl Fischer

FTIR

XRPD

Job description

Vertex Pharmaceuticals LLC seeks an Associate Director, QC Technical Services – Small Molecule, to lead a team responsible for GMP release and stability testing at external laboratories supporting commercial programs. You will drive compliance, performance metrics, and cross-functional collaboration to ensure uninterrupted supply.

The role requires a strong analytical chemistry background, hands-on leadership, and the ability to manage complex projects in a fast-moving biopharma environment.