Quality Control Lead – Stability & Regulatory Compliance

Jobtailor; Boston (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

Jobtailor, based in Boston, seeks an experienced Quality Control Leader to drive clinical and commercial drug substance and drug product QC activities in line with ICH and cGMP. You will oversee stability programs, master specifications, and release testing across API and drug products.

This role requires collaboration with QA, external labs, CMOs, and cross-location teams, leading investigations (OOS/OOT), CAPAs, and audits. Travel up to 20% and onsite presence at Boston office 2 days/week.

Qualifications

• Undergraduate degree in life sciences.
• 8+ years of relevant management experience in the pharmaceutical industry.
• Experience with small molecules and/or biologics.
• Experience working with external testing laboratories.
• Ability to work independently and influence in a fast-paced environment.
• Strong quality mindset.
• Travel up to 20% domestically and internationally.
• Willingness to work onsite at the Boston office at least 2 days per week.

Responsibilities

• Lead Quality Control activities supporting clinical and commercial drug substance and drug product programs per ICH and cGMP.
• Manage master specifications for starting materials, reference standards, API, and drug products.
• Lead stability activities, including trending, evaluation, shelf-life extensions, and risk evaluation.
• Lead OOS and OOT investigations and draft reports with internal teams and external labs.
• Review and manage analytical and non-analytical results for release and stability.
• Coordinate audits of external laboratories and CMOs; conduct remote/onsite audits as needed.
• Collaborate with QA on release documents (COA/Certificate of Testing) and with Drug Product/API groups on trial material deliverables.
• Support transfer of new drug candidates to CMC development; oversee tech transfers and sample movement.
• Ensure deviations, change controls, and CAPAs are properly managed.

Skills

Quality Control Leadership

Stability Program Management

OOS/OOT Investigations

Regulatory Knowledge (ICH, cGMP)

External Lab Collaboration

Team Leadership

CAPA Management

Written & Verbal Communication

Education

Undergraduate degree in life sciences

Tools

Quality Management Systems

Method Validations

Master Specifications

Job description

Jobtailor, based in Boston, seeks an experienced Quality Control Leader to drive clinical and commercial drug substance and drug product QC activities in line with ICH and cGMP. You will oversee stability programs, master specifications, and release testing across API and drug products.

This role requires collaboration with QA, external labs, CMOs, and cross-location teams, leading investigations (OOS/OOT), CAPAs, and audits. Travel up to 20% and onsite presence at Boston office 2 days/week.