Vertex · 4 hours ago
GMP Operational Quality Manager (QA on the Floor)
Boston, MA
Full-time
Onsite
Mid, Senior Level
$118K/yr - $178K/yr
4+ years expVertex Pharmaceuticals Inc is a global biotechnology company that invests in scientific innovation. They are seeking a GMP Operational Quality Manager who will lead quality assurance activities on the floor, ensuring compliance with cGMPs while coordinating various quality projects and initiatives.
Computer Software
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
Author SOP's to support commercial quality functions
Assist with regulatory agency inspections
Identify and facilitate continuous improvement efforts
Train employees and provide insights and education on processes and procedures
Perform activities associated with product disposition (e.g., batch document review, source data review etc.)
Gown into cleanrooms and controlled environments
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
Inclusive market-leading 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
Vendor intelligence that combs through your supplier, manufacturer, logistics data to detect where you're leaving money on the table.
2-10 employees
H1B Sponsorship
Vertex 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
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Trends of Total Sponsorships
2025 (27)
2024 (18)
2023 (7)
2022 (13)
2021 (5)
2020 (7)
Funding
Current Stage
Early StageCompany data provided by crunchbase