Generate:Biomedicines · 2 days ago
Senior Director, GCP & GPV Quality
Somerville, MA
Full-time
Hybrid
Director/Executive
$210K/yr - $315K/yr
10+ years expGenerate:Biomedicines is a pioneering therapeutics company focused on Generative Biology™ to create breakthrough medicines. The Senior Director, GCP & GPV will lead clinical quality and pharmacovigilance strategy, ensuring compliance and fostering a culture of quality, while overseeing a team of professionals.
Artificial Intelligence (AI)BiotechnologyHealth CareMedicalProduct Research
Hiring Manager
Kimberly Demetriou
Responsibilities
Lead GCP and GPV quality strategy and execution across clinical programs, ensuring compliance with FDA, EMA, and other global regulations
Maintain a phase-appropriate Quality Management System (QMS) for clinical and pharmacovigilance activities, including SOPs, training, document control, and vendor oversight
Oversee clinical quality and pharmacovigilance activities: site/vendor audits, deviation management, CAPAs, and safety reporting compliance
Serve as the primary contact for internal teams and CROs/vendors on clinical quality and safety matters
Support EU clinical compliance and collaborate with the Qualified Person (QP) on European clinical supply certification and release
Drive inspection readiness and support regulatory inspections and submissions (IND, CTA, BLA, MAA)
Develop and monitor key quality and safety metrics to identify risks, ensure patient safety, and support continuous improvement
Lead, mentor, and develop a small team of GCP/GPV professionals
Partner with Regulatory Affairs to align quality and safety with regulatory strategy
Set high standards for performance and accountability, ensuring clarity of expectations and outcomes
Recruit, develop, and retain diverse, high-performing team members
Foster transparent, courageous communication and cross-functional collaboration
Encourage adaptability and calculated risk-taking, modeling resilience through change
Qualification
Required
BS or advanced degree in biology, chemistry, life sciences, or related field
10+ years in biotech/pharma, with 6+ years in clinical quality and pharmacovigilance leadership
Strong knowledge of GCP, GPV, and global regulatory expectations, including EU regulations
Experience supporting both early- and late-stage development programs
Demonstrated success with inspection readiness and direct interactions with health authorities
Strong communication, collaboration, and leadership skills in a fast-paced, high-growth environment
Preferred
Prior experience with regulatory submissions
Proven ability to influence cross-functional stakeholders in an outsourced model
Benefits
Annual bonus
Equity compensation
Competitive benefits package
Company
Generate:Biomedicines
Pioneering generative biology to create breakthrough therapeutics.
201-500 employees
H1B Sponsorship
Generate:Biomedicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (12)
2023 (9)
2022 (3)
2021 (2)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
$693MKey Investors
Samsung Life Science FundAlumni VenturesFlagship Pioneering
2024-12-18Series Unknown
2023-09-14Series C· $273M
2021-11-18Series B· $370M
Leadership Team
Gevorg Grigoryan
Founding CTO
Recent News
FierceBiotech
2025-10-28
Company data provided by crunchbase