Vertex Pharmaceuticals · 13 hours ago
GMP Operational Quality Manager (QA Ops for QC)
Boston, MA
Full-time
Onsite
Mid Level
$118K/yr - $178K/yr
4+ years expVertex Pharmaceuticals is a global biotechnology company that invests in scientific innovation. The GMP Operational Quality Manager is responsible for overseeing quality assurance and compliance activities, collaborating with various teams to ensure adherence to cGMP standards while supporting the testing and release of cell therapy products.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Collaborate with internal and external business partners to resolve quality issues to ensure compliant solutions
Lead root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified
Perform change control assessments and closure approvals
Establish and revise Quality Agreements between CMOs/Suppliers and Vertex, as needed
Collect data and report on metrics
Represent Vertex Quality on cross functional working teams, applying strong communication and collaboration skills
Lead continuous improvement projects
Authors and reviews data, SOPs, COAs, analytical methods, protocols, and reports
Assist with regulatory agency inspections
Identify and facilitate continuous improvement efforts
Support the lead point of contact for QA activities occurring at multiple contract manufacturing and test organizations, including release & stability testing, method equipment/software validation, and adherence to project timelines
Support QA operations for a gene edited hemoglobinopathy cell therapy product and helps troubleshoot technical aspects of analytical methods related to the release of biologics and cell therapy products
Ensures all external laboratory records adhere to cGMP/GDP expectations
Supports compliance related teams working towards the goal of continuous improvement
Assists with OOS/OOT investigations/deviations and to identify corrective actions to prevent reoccurrence
Qualification
Required
Good understanding of both the conceptual and practical application of cGMPs in a pharmaceutical setting
Proven experience leading a variety of straightforward projects/teams within stated objectives and timelines
Ability to communicate effectively with cross functional team members, exchanging complex information and influencing/guiding others to understand a stated viewpoint
Ability manage own workload to achieve goals and seek opportunities to share information and help others understand technical processes
Formal project management experience
Strong communication skills (written and verbal) with the ability to communicate to a variety of audiences
Able to integrates activities with other groups, departments and project teams as needed
Demonstrated ability to evaluate quality matters and solve problems leveraging technical experience and advanced judgement to select appropriate solutions
Excellent team player and collaborator
Highly proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA
Experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva)
Bachelor's degree in scientific or allied health field (or equivalent degree)
Typically requires 4+ years of experience, or the equivalent combination of education and experience
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
2026-01-23
Benzinga.com
2026-01-23
2026-01-22
Company data provided by crunchbase