Generate:Biomedicines · 5 days ago
Vice President, Head of Quality
Somerville, MA
Full-time
Hybrid
Director/Executive
$262K/yr - $375K/yr
20+ years expGenerate:Biomedicines is a pioneering therapeutics company at the intersection of machine learning, biological engineering, and medicine. They are seeking a VP, Head of Quality to build and lead a Quality organization that ensures compliance and supports global clinical trials, while collaborating with machine-learning and data scientists to innovate drug development processes.
Artificial Intelligence (AI)BiotechnologyHealth CareMedicalProduct Research
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
Qualification
Required
BS or advanced degree in biology, chemistry, or engineering disciplines
Minimum of 20 years of experience in the biotechnology industry
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
Benefits
Annual bonus
Equity compensation
Competitive benefits package
Company
Generate:Biomedicines
Pioneering generative biology to create breakthrough therapeutics.
201-500 employees
H1B Sponsorship
Generate:Biomedicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (12)
2023 (9)
2022 (3)
2021 (2)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
$693MKey Investors
Samsung Life Science FundAlumni VenturesFlagship Pioneering
2024-12-18Series Unknown
2023-09-14Series C· $273M
2021-11-18Series B· $370M
Leadership Team
Gevorg Grigoryan
Founding CTO
Recent News
FierceBiotech
2025-10-28
Company data provided by crunchbase