Senior Director, Clinical Quality Assurance

The Senior Director, Clinical Quality Assurance will lead the clinical quality strategy related to company sponsored clinical trial activities. The candidate will ensure quality and compliance support of the Clinical team in compliance with Good Clinical Practices (GCP) and FDA/EMA/ICH regulations. The Senior Director will drive proactive risk identification and mitigation across clinical development and pharmacovigilance lifecycle, ensuring inspection readiness. Routine activities include compliance oversight activities, reviewing GCP documents and attending cross functional team meetings.NOTE: This is a hybrid role with 3 days a week in office in Boston, MA.ResponsibilitiesProvide senior-level leadership regarding GCP quality strategy, compliance, and operations for leadership and cross-functional teams to ensure that clinical trials are conducted by Clinical Research Organizations (CROs) in compliance with GCP regulations and internal requirementCollaborate with cross-functional teams to identify potential internal or external risks to GCP compliance and develop mitigation strategies, conforming to regulatory requirements (FDA, ICH (R3), EMA) and industry standardsProvide QA review of the clinical protocols, amendments, Informed Consent Forms, Clinical Study Reports, Investigator Brochures, and other relevant documentsDevelop, implement, and maintain phase-appropriate Quality Management Systems for clinical and pharmacovigilance activities including SOPs, training, document control and vendor oversight.Serve as the primary Quality Contact for internal teams and CROs/vendors, contract laboratories, on clinical quality and safety matters.Drive inspection readiness and support regulatory inspections and submissions (IND, CTA, NDA, MAA)Investigate deviations, non-compliances, and quality issues related to GCP and develop CAPAs to prevent recurrence and improve processes.Identify, track, and manage CAPAs arising from audits, inspections, deviations, and non-conformances; ensure timely completion, effectiveness verification, and documentation of all CAPAs in alignment with regulatory requirements.Conduct Trial Master File auditsDeliver and assign GCP training content for internal PepGen employees. Maintain GCP training files and monitor compliance with trainingEstablish and maintain internal procedures in compliance with FDA, ICH, EU, and other country-specific regulationsDrive continuous improvement initiatives to enhance the efficiency, effectiveness, and quality of GCP-related processes and procedures.Participate in Health Authority inspectionsRequirementsBachelor’s degree in life sciences, pharmacy, nursing or a related fieldExperience leading and/or conducting audits, audit certification preferredSubject matter expertise in GCP guidelines, ICH-GCP, FDA regulations, and other relevant regulatory requirementsExperience conducting GCP audits, inspections, and vendor qualifications / assessmentsExperience supporting both early and late state development programsExperience in Ph3 readiness Excellent interpersonal and communication skills (written and verbal), team player, and flexibility without compromising qualityDetail-oriented mindset with a proactive approach to problem-solving and decision making Ability to work independentlyA minimum of 15 years’ experience in CRO or GCP roles and no less than 8 years in a sponsor quality roleCompensationThe estimate full-time salary range for this role is between $235,000 to $295,000. The final compensation package offered to a successful candidate will reflect a number of factors including but not limited to prior experience, relevant skills, education, qualifications and certifications, business needs, internal equity, and market data.PepGen provides eligible employees a comprehensive and competitive total compensation package including but not limited to a discretionary annual bonus, equity, health insurance (including medical, dental, and vision), life and disability insurance, paid time off with paid holidays, paid parental leave, a 401(k) plan, cell phone reimbursement, student loan repayment or 529 contributions, and a lifestyle spending account.