Vertex Pharmaceuticals · 15 hours ago
Director, GMP Operational Quality
Boston, MA
Full-time
Onsite
Director/Executive
$185K/yr - $277K/yr
10+ years expVertex Pharmaceuticals is a global biotechnology company that invests in scientific innovation. The Director, Quality Assurance GMP Operations will oversee GMP QA operations, ensuring compliance and continuous improvement across batch disposition processes for drug products globally.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Establishment of quality oversight for internal quality and external CTO/CDMO operations for the batch disposition process, across development, launch and commercial manufacturing globally
Proactively drives continuous improvements in processes, identifies and mitigates compliance gaps and drive culture of quality across all operational activities
Manage the day-to-day timely release of finished product to ensure compliance with Regulatory and Vertex cGMP requirements
Represent Quality and serve as a trusted partner for the disposition activities of drug product
Lead and mentor other team members, support development of organizational capabilities and talent building
Assure disposition activities across CDMOs are compliant and consistent
Ensure adequate training to the Department personnel
Manage the department resources with regards to budget and personnel
Build strategic relationships with internal and external partners – CDMOs and CTOs within the Quality organization to ensure Quality issues are raised and addressed, as necessary
Create and foster a culture of collaboration, development, and engagement for advancing quality outcomes and operational excellence
Develop, establish, and implement Batch disposition operational Quality and Compliance metrics
Act as the batch disposition subject matter expert (SME) in support of regulatory inspections and audits
Establish/participate and lead GxP Cell & Gene Therapy Management Reviews to gain insights regarding efficiency and operational performance across the GXP operations, including identification of opportunities for improvement and associated actions
Work closely with the cross- functional partners to prepare for and support Health Authority inspections, respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions
Represent C&G Quality to lead/participate in complex projects and partner with key stakeholders for alignment in strategic and operational planning and delivery of business & financial priorities and goals
May be required to support manufacturing on site activities
Qualification
Required
Bachelor's degree or Master's degree or equivalent
10+ years of experience and 5+ years in a management/supervisory role, or the equivalent combination of education and experience in a regulated pharmaceutical environment
In-depth global health regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics (EU GMPs, FDA 21CFR Part 1271, GxPs)
Broad and current knowledge of batch disposition industry trends and best practices in Cell/Gene therapies
Broad technical knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing
Demonstrated strategic planning and execution skills required for operational effectiveness and compliance. Proven ability with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma
Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence
Ability to apply risk management principles to decision making and operational priorities
Critical Thinking and Problem Solving skills
Ability to closely collaborate and build relationships with internal and external stakeholders
Preferred
Preferred QA Operational experience for Autologous Cell Therapy Operations
Benefits
Medical, dental and vision benefits
Generous paid time off (including a week-long company shutdown in the Summer and the Winter)
Educational assistance programs including student loan repayment
A generous commuting subsidy
Matching charitable donations
401(k)
Company
Vertex Pharmaceuticals
Vertex Pharmaceuticals is focused on the discovery and development of small molecule drugs for the treatment of serious diseases.
5001-10000 employees
H1B Sponsorship
Vertex Pharmaceuticals 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 (188)
2024 (150)
2023 (111)
2022 (164)
2021 (112)
2020 (80)
Funding
Current Stage
Public CompanyTotal Funding
$657.31MKey Investors
Janssen Belgium
2024-07-10Post Ipo Secondary· $1.11M
2022-05-17Post Ipo Equity· $50M
2009-12-03Post Ipo Equity· $443M
Leadership Team
Reshma Kewalramani
CEO and President
Nina Devlin
Senior Vice President, Chief Communications Officer
Recent News
Pharma Letter
2026-02-04
2026-02-03
Company data provided by crunchbase