Director/Sr. Director, Quality Assurance (GCP/GMP)

Frontier Medicines Corporation; Boston (MA); On-site; USD 200,000 - 275,000; Full time

Benefits offered by this job

Health Care Plan (Medical, Dental &amp

Retirement Plan (401k, IRA)

Life Insurance (Basic, Voluntary &

Paid Time Off (Vacation, Sick &

Family Leave (Maternity, Paternity)

Short Term & Long Term Disability

Training & Development

Free Food & Snacks

Wellness Resources

Stock Option Plan

Job summary

Frontier Medicines Corporation is seeking a Director/Sr. Director, Quality Assurance to lead and scale our QMS as our small molecule pipeline advances from Phase 1/2 toward global registration.

You will own GCP compliance across global clinical trials, provide phase-appropriate GMP oversight for API and drug product programs, and build an inspection readiness roadmap with CMC and external partners. Ideal candidates bring dual GCP/GMP expertise and a hands-on yet strategic mindset for a lean,

Qualifications

• Bachelor’s degree in Chemistry, Pharmacy, Biochemistry or related field.
• 8+ years of QA experience in pharma/biotech, with 3+ years in leadership in a clinical-stage setting.
• Direct QA management for small molecule drug development, including CMC/GMP oversight.
• Strong knowledge of ICH GCP guidelines and phase-appropriate GMP regulations.
• Familiarity with US FDA and EU/EMA/PMDA/NMPA regulatory frameworks is advantageous.
• Experience implementing or managing modern eQMS systems (Veeva/TrackWise/KMS).
• Proven ability to thrive in a lean, fast-paced biotech environment with hybrid hands-on/leadership style.
• Excellent communication and stakeholder management; legally authorized to work in the United States.

Responsibilities

• Establish, maintain, and oversee the global GCP compliance strategy for Phase 1–2 trials and upcoming registrational studies.
• Lead qualification, selection, and auditing of CROs, trial sites, labs, and vendors across US, EU, and Asia.
• Design and execute annual risk-based GCP audit plans including site, vendor, and internal process audits.
• Review and approve critical clinical documents such as protocols, ICFs, and CSRs.
• Provide QA oversight of CMOs handling small molecule API synthesis, solid-state formulation, packaging, and labeling.
• Oversee disposition of clinical trial material batches to ensure compliance with global standards.
• Negotiate and maintain Quality Agreements with CMOs and material suppliers.
• Collaborate with CMC to investigate deviations and CAPAs as processes scale toward registration.
• Maintain and improve the eQMS to scale from early clinical phases to commercial readiness.
• Lead investigations into quality issues and root-cause analyses; ensure timely CAPAs.
• Prepare corporate inspection readiness roadmap for FDA, EMA, and other agencies; act as QA host during inspections.

Skills

QA leadership

GCP/GMP expertise

Small molecule

Regulatory knowledge (FDA/EU/EMA/PMDA/

eQMS (Veeva/TrackWise)

Root cause analysis & CAPA

Stakeholder management

US work authorization

Education

Bachelor’s degree in Chemistry/Pharmacy/Biochemistry

Tools

Veeva Vault Quality

ZenQMS

TrackWise

Job description

What’s in it for you?

Frontier Medicines is seeking a Director/Sr. Director, Quality Assurance to lead and scale our Quality Management System (QMS) as our small molecule pipeline advances from Phase 1/2 toward global registration over the next 2–3 years. This role will hold ultimate accountability for Good Clinical Practice (GCP) compliance across our global clinical trials while providing phase‑appropriate Good Manufacturing Practice (GMP) oversight for our drug substance (API) and drug product programs.

Working in close partnership with Clinical Operations, CMC, and external partners, the Director will build the inspection readiness roadmap that bridges early‑stage trials and commercial marketing authorization. The ideal candidate brings dual GCP/GMP expertise, deep small molecule experience, and a hands‑on yet strategic mindset suited to a lean, fast‑moving biotech environment.

What will you be doing?

• Establish, maintain, and oversee the global GCP compliance strategy for Phase 1–2 clinical trials, and prepare quality systems for upcoming registrational studies


• Lead the qualification, selection, and routine auditing of CROs, clinical trial sites, central labs, and bioanalytical vendors across the US, EU, and Asia


• Design and execute the annual risk‑based GCP audit plan, including investigator site, vendor, and internal process audits


• Review and approve critical clinical documents, including protocols, Investigator Brochures, Informed Consent Forms, and Clinical Study Reports


• Provide QA oversight of external CMOs handling small molecule API synthesis, solid‑state formulation, packaging, and labeling


• Oversee review and phase‑appropriate disposition of clinical trial material batches to ensure production meets global regulatory standards


• Negotiate, author, and maintain Quality Agreements with CMOs and critical raw material suppliers


• Partner with CMC to investigate manufacturing deviations, OOS results, and stability data anomalies as processes scale toward registration


• Maintain and continuously improve the eQMS so it scales from early clinical phases to commercial readiness


• Lead investigations into quality issues, deviations, and serious breaches, ensuring robust root‑cause analysis and timely execution of CAPAs


• Author and execute a corporate inspection readiness roadmap for FDA (BIMO), EMA, and Asian regulatory agency inspections, and serve as primary QA host or back‑room lead during inspections

Traits we believe make a strong candidate:

• Bachelor’s degree or higher in Chemistry, Pharmacy, Biochemistry, or a related scientific discipline


• 8+ years of QA experience in the pharmaceutical or biotech industry, including at least 3 years in a leadership or senior management role in a clinical‑stage setting


• Direct experience managing QA for small molecule drug development, including CMC/GMP oversight of chemical synthesis, solid‑state formulation, and stability testing


• Robust expertise in global ICH GCP guidelines alongside strong working knowledge of phase‑appropriate GMP regulations


• Strong familiarity with US FDA frameworks; experience with EU/EMA and Asian regulatory frameworks (e.g., PMDA, NMPA) is highly beneficial


• Experience implementing or managing a modern eQMS (e.g., Veeva Vault Quality, ZenQMS, TrackWise)


• Proven success in a lean, fast‑paced biotech environment that calls for a hybrid hands‑on and high‑level approach


• Strong communication and stakeholder management skills


• Legally authorized to work in the United States

• Health Care Plan (Medical, Dental & Vision)


• Retirement Plan (401k, IRA)


• Life Insurance (Basic, Voluntary & AD&D)


• Paid Time Off (Vacation, Sick & Public Holidays)


• Family Leave (Maternity, Paternity)


• Short Term & Long Term Disability


• Training & Development


• Free Food & Snacks


• Wellness Resources


• Stock Option Plan

At Frontier, we strive to build a diverse and equitable workplace. The salary range for this role is $200,000 - $275,000. Compensation for the role will depend on a number of factors, including candidates' qualifications, skills, competencies and experience. Frontier offers a competitive total rewards package which includes healthcare coverage, 401k and a broad range of other benefits.

This compensation and benefits information is based on Frontier's knowledge as of the date of publication, and may be modified in the future.