Senior Director, GMP Quality

Generate Biomedicines•Somerville, MA

5h•$210,000 - $290,000

About The Position

The Senior Director, GMP Quality will build/support and maintain fit-for-purpose quality systems, provide independent quality oversight of contract development and manufacturing organizations (CDMOs), contract testing laboratories, and other strategic partners, and ensure the company’s products and processes meet applicable regulatory, GxP, and company requirements. This is a hands-on individual contributor leadership role that will partner closely with Technical Operations, Regulatory Affairs, Clinical Development, Supply Chain, external vendors, and internal company stakeholders to support programs from development through commercialization. This role will report to the Vice President, Head of Quality.

Requirements

Bachelors degree in a relevant scientific discipline and 15+ years of biopharmaceutical industry experience
Extensive GxP quality leadership experience supporting biologics development, including GMP and GLP operations.
Strong understanding of quality systems, including deviations, investigations, CAPAs, change controls, OOS/OOT management, data integrity, and inspection readiness.
Experience providing quality oversight across preclinical, CMC, clinical manufacturing, quality control, supply chain, and product lifecycle activities.
Strong knowledge of biologic products regulations, process validation, method validation, stability, comparability, specifications, and control strategies.
Proven ability to establish phase-appropriate Quality strategies and scalable systems for early- and late-stage development programs.
Significant quality oversight experience working with CDMOs, CROs, contract testing laboratories, suppliers, and other external partners.
Experience leading audits, quality agreements, partner performance management, investigations, remediation, and risk mitigation.
Demonstrated success supporting regulatory submissions, health authority interactions, inspections, and responses to regulatory findings.
Experience partnering with Technical Operations, Preclinical, Regulatory, Clinical, Manufacturing, and Supply Chain teams.
Proven ability to build, mentor, develop and lead high performing Quality Teams
Excellent communication and influencing skills, with the ability to explain complex scientific, regulatory, and quality matters to executive leadership and external stakeholders.
A strategic, proactive, and hands-on leader who anticipates risk, makes sound decisions, and holds teams and partners accountable.
Commitment to patient safety, product quality, data integrity, compliance, and continuous improvement.

Nice To Haves

Involvement in pre-approval inspections, regulatory inspections, and commercialization readiness for biologics.
Exposure to highly outsourced or virtual biotechnology operating model.
Involved in implementing new quality technologies, electronic systems, automation, or data-driven quality tools
Global experience with health authorities, suppliers, and development or manufacturing partners.
Strategic Quality and GMP leadership for combination drug product development

Responsibilities

Establish and maintain a scalable, risk-based GxP Quality framework covering analytical testing, manufacturing, technology transfer, validation, product lifecycle management, and regulatory commitments.
Provide independent, phase-appropriate Quality oversight of CMC and analytical strategies, including control strategies, CQAs, CPPs, specifications, method development and validation, comparability, stability, reference standards, and lifecycle management.
Serve as an enterprise Quality leader and strategic advisor to Technical Operations, Regulatory Affairs, Supply Chain, executive leadership, and cross-functional teams on product quality, supply continuity, regulatory readiness, and business objectives.
Build a culture of quality, accountability, scientific rigor, collaboration, and proactive risk management across Generate and its external partners.
Lead Generate’s CMC Quality relationships with CDMOs, contract testing laboratories, and other technical partners, including qualification, quality agreements, governance, performance management, audits, and issue escalation.
Provide Quality oversight of outsourced development, manufacturing, testing, packaging, and storage activities, ensuring compliant and timely execution of clinical supply, GMP release, stability, validation, and lifecycle management activities.
Provide Quality leadership across technology transfer, scale-up, process characterization, manufacturing changes, comparability, continued process verification, and other product and process lifecycle activities.
Review and approve key GMP and regulatory documentation, and provide quality leadership for manufacturing campaigns, batch review and release, deviations, investigations, OOS/OOT results, CAPAs, change controls, product disposition, and other significant quality events.
Drive product quality risk management, audit and inspection readiness, data integrity, computerized systems compliance, and alignment with global regulatory expectations, cGMP requirements, quality agreements, and Generate standards.
Support global regulatory submissions and health authority interactions by developing and reviewing CMC/QC Quality content, assessing data and control strategies, and supporting responses to regulatory questions.
Establish and monitor Quality performance indicators, identify evolving regulations and industry pr