Vice President, Head of Quality

Generate Biomedicines•Somerville, MA

19d•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: Generate is seeking a highly experienced and innovative VP, Head of Quality to join our growing team. They will be responsible for building, leading, and inspiring a Quality organization that promotes a best-in-class Quality culture to enable the robust execution of global clinical trials. This is a new organization within Generate Biomedicines, so the leader will be accountable for building and shaping the Quality organization aligned with the growth of the company and productivity of the portfolio. This is an influential role that is well poised to grow as a leader more broadly supporting the breadth of Generate’s platform and pipeline. This person will work closely with our machine-learning and data scientists to revolutionize drug development by leveraging progressive tools, data, and innovative business processes. This role will report directly to the Chief Legal Officer with full end-to-end Quality responsibilities spanning early discovery through pivotal late-stage development, clinical trials, and commercial readiness—including GLP, GCP, GVP, and GMP. Proven leadership in late-stage clinical development, including oversight of pivotal trials and regulatory readiness, will be essential.

Requirements

BS or advanced degree (preferred) in biology, chemistry, or engineering disciplines with a minimum of 20 years of experience in the biotechnology industry, including 10+ years of progressive Quality leadership experience supporting biologics and small molecule programs across early discovery, clinical development, and late-stage/pivotal trial readiness through commercialization.
Multidiscipline expertise in GCP and CMC QA with familiarity in Non-Clinical requirements.
Experience establishing Quality systems in a phase-appropriate manner.
Excellent working knowledge and implementation experience of FDA and EMA regulations and guidelines in GLP, GCP, and GxP environments.
Experience with cGMP requirements for clinical and commercial products and firsthand experience hosting regulatory inspections.
Successful track record contributing to IND, BLA, and MAA submissions for novel products.
Experience leading GxP Quality programs for the development and approval of drug-device combination products
Proven capability to lead and inspire within and beyond Quality organizations.
Exceptional communication skills at all levels, including Board and external partners.
Proven experience building high-performing quality teams, with strength in recruiting, mentoring, and performance management.
A self-reflective leader who exemplifies continuous improvement and openness to feedback.
Ability to influence and lead within a matrixed organization with transparency.
Comfort navigating ambiguity, rapid growth, and organizational change.

Responsibilities

Establish global quality strategies to ensure compliance and efficient product approvals.
Partner cross-functionally to align Quality strategy and execution across the full development lifecycle—from early discovery, IND-enabling studies, and clinical development through pivotal trial readiness and commercialization—ensuring cGMP, GCP, GVP, and GLP compliance.
Direct and oversee quality planning and execution for late-stage, registration-enabling programs to ensure robust outcomes and regulatory submission readiness.
Develop short- and long-term plans to achieve both quality and business objectives.
Ensure that the quality policy and objectives are understood, implemented, and maintained at all levels of the organization.
Assure that the appropriate suite of Standard Operating Procedures are in place and optimally maintained to support critical drug development activities and vendor relationships with external CROs and CMOs.
Ensure quality systems and processes are appropriate for the development, manufacture, testing, release, and distribution of product, consistent with global quality strategy and regulatory requirements.
Lead GxP Quality programs for the development and approval of drug-device combination products
Ensure a robust and risk-based audit program is successfully realized throughout our vendor network.
Negotiate, develop, and manage quality agreements with CMOs, CROs, partners, and suppliers.
Develop key quality system metrics and process indicators to proactively identify and address quality systems or product issues.
Lead Quality Management Review and ensure no significant interruptions to the business due to quality or compliance issues.
Champion continuous improvement in all aspects of total quality management through a well-trained workforce and streamlined processes.
Interface directly with FDA, EMA, and other regulatory authorities on matters related to compliance and quality, especially in support of late-stage trials and pre-approval activities.
Build and develop a high-performing Quality organization and lead staff development in connection with strategic goals and operational systems.
Develop resource strategies and allocate budget, staff, tools, and support for efficient operations.
Lead and guide partner companies and external suppliers through collaborative, goal-oriented engagements enabling compliant success and execution.