Senior Director, GCP & GPV Quality

Generate Biomedicines•Somerville, MA

16d•Hybrid

About The Position

About Generate:Biomedicines Generate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development. We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us! Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees. The Role: The Senior Director, GCP & GPV will lead clinical quality and pharmacovigilance strategy across development-stage programs. This role ensures global Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPV) compliance, provides guidance on clinical trial operations and safety reporting, and fosters a culture of quality, compliance, and patient safety. The Senior Director drives proactive risk identification and mitigation across the clinical development and pharmacovigilance lifecycle, ensuring inspection readiness and effective regulatory engagement. This leader will partner cross-functionally to embed quality and safety considerations in clinical planning and will oversee a small, high-performing team of quality and pharmacovigilance professionals. Here's how you will contribute:

Requirements

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.

Nice To Haves

Prior experience with regulatory submissions.
Proven ability to influence cross-functional stakeholders in an outsourced model.

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.