Vice President, Head of Quality

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 millionin 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 Generates 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 readinessincluding GLP GCP GVP and GMP. Proven leadership in late-stage clinical development including oversight of pivotal trials and regulatory readiness will be essential.

Heres how you will contribute:

• Establish global quality strategies to ensure compliance and efficient product approvals.
• Partner cross-functionally to align Quality strategy and execution across the full development lifecyclefrom early discovery IND-enabling studies and clinical development through pivotal trial readiness and commercializationensuring 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.

The Ideal Candidate will have:

• 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.

Location: Somerville MA (Hybrid-onsite minimum 2-3 days per week)

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 Companys 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.