Senior Director, Clinical Quality Assurance
NOTE: This is a hybrid role with 3 days a week in office in Boston, MA.
Responsibilities
- Provide 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 requirement
- Collaborate 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 standards
- Provide QA review of the clinical protocols, amendments, Informed Consent Forms, Clinical Study Reports, Investigator Brochures, and other relevant documents
- Develop, 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 audits
- Deliver and assign GCP training content for internal PepGen employees. Maintain GCP training files and monitor compliance with training
- Establish and maintain internal procedures in compliance with FDA, ICH, EU, and other country-specific regulations
- Drive continuous improvement initiatives to enhance the efficiency, effectiveness, and quality of GCP-related processes and procedures.
- Participate in Health Authority inspections
- Bachelor’s degree in life sciences, pharmacy, nursing or a related field
- Experience leading and/or conducting audits, audit certification preferred
- Subject matter expertise in GCP guidelines, ICH-GCP, FDA regulations, and other relevant regulatory requirements
- Experience conducting GCP audits, inspections, and vendor qualifications / assessments
- Experience supporting both early and late state development programs
- Experience in Ph3 readiness Excellent interpersonal and communication skills (written and verbal), team player, and flexibility without compromising quality
- Detail-oriented mindset with a proactive approach to problem-solving and decision making Ability to work independently
- A minimum of 15 years’ experience in CRO or GCP roles and no less than 8 years in a sponsor quality role
Compensation
The 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.
About PepGen
PepGen is a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen’s Enhanced Delivery Oligonucleotide (EDO) platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates designed to target the root cause of serious diseases.
For more information, please visit PepGen.com. Follow PepGen on LinkedIn and X.
EEO Statement
PepGen is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.
Recruitment & Staffing Agencies
PepGen does not accept unsolicited agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited. Thank you.
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