Director, GMP Quality

Director, Gmp Quality

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

We are seeking a Director of GMP Quality to lead and operationalize quality assurance activities for early development and clinical manufacturing programs. This is a hands-on leadership role responsible for ensuring compliance with GxP requirementsprimarily GMP and GLPas well as quality oversight of external partners supporting preclinical, CMC and Supply Chain activities.

The Director will work closely with colleagues in Technical Operations, CMC, Preclinical, and Regulatory to ensure that quality standards are met across all development-stage programs. This role will report to the Senior Director of GxP Quality.

Here's How You Will Contribute

• Lead GMP Quality oversight for clinical drug substance and drug product manufacturing and testing at external CDMOs and labs.
• Lead GMP Quality oversight for supply chain partners including packaging, labeling and distribution to clinical sites for global, late-stage trials.
• Responsible for clinical batch release including liaising with QP certification and importation requirements where applicable.
• Leads Material Review Board (MRB) discussions when required.
• Provide quality support for GLP and preclinical studies, including document review and quality guidance for nonclinical development teams.
• Author, review, and maintain phase-appropriate SOPs, quality agreements, and controlled documents.
• Responsible for Quality System oversight including QEs, CAPA, and Change Control.
• Manage vendor qualification and auditing processes, and support investigations, deviations, and CAPAs.
• Support batch record review, CMC documentation, and release of GMP drug substance, drug product and finished goods.
• Assist in preparation for regulatory submissions (e.g., INDs) by ensuring data and processes are GxP-compliant.
• Maintain quality metrics and dashboards to monitor performance and identify risk trends.
• Partner with cross-functional teams to embed quality into early-stage development workflows and support preclinical quality where necessary.
• Partner with CMC and external consultants to build a device-specific QMS in support of drug-device combination product development.
• Provide inspection readiness support and participate in regulatory inspections when applicable.

The Ideal Candidate Will Have

• BS or equivalent in life sciences or related field; advanced degree preferred.
• 10+ years of biotech/pharma experience with a strong background in GMP quality, and exposure to GLP or preclinical quality oversight.
• Proven experience in early-stage quality operations, ideally in a small or growing company environment.
• Hands-on experience working with CDMOs and external testing labs.
• Strong understanding of FDA and EMA regulations and expectations for early-stage development and late-stage planning.
• Familiarity with regulatory requirements for combination products (e.g., 21 CFR Part 4, ISO 13485, EU MDR) is a plus.
• Extensive experience with Quality Assurance systems and processes.
• Excellent attention to detail, organizational skills, and the ability to work cross-functionally.
• Strong written and verbal communication skills.
• Comfortable working independently and collaboratively in a dynamic, fast-paced environment.

Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status.

Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.