Vertex · 9 hours ago
GMP Operational Quality Senior Manager (Quality Engineering/Validation)
Boston, MA
Full-time
Onsite
Senior Level, Lead/Staff
$136K/yr - $205K/yr
8+ years expVertex Pharmaceuticals Inc is a global biotechnology company that invests in scientific innovation. They are seeking a Senior Manager, Quality Assurance Technical Services to provide quality support and oversight for Quality Engineering and Validation programs at their Cell and Genetic Therapies sites.
Computer Software
Responsibilities
Provide quality oversight and ensure compliance with standards across internal Vertex CGT manufacturing sites
Execute the validation QA activities for drafting, review, approval and execution of validation documents
Support return-to-service cleaning, testing, and GMP release of facilities/equipment for change controls
Execute calibration and Maintenance program QA activities
Review and analyze program effectiveness, identifying gaps and opportunities for improvement
Lead quality event investigations, root cause analysis, and corrective actions
Support return-to-service cleaning, testing, and GMP release of facilities/equipment for change controls
Partner with cross-functional teams to ensure timely completion of periodic trend reports and implementation of corrective actions
Monitor and track performance metrics, presenting them at Quality forums, site leadership and management review forums
Execute on calibration and maintenance program QA oversight activities
Collaborate with project teams to ensure alignment and timely resolution of issues
Participate and provide compliance oversight for quality systems, including change controls, deviation investigations, CAPA, and effectiveness checks
Conduct risk identification, gap analysis, and implement robust corrective actions
Lead or participate in process optimization workstreams and continuous improvement initiatives
Participate in inspection readiness activities and support regulatory site inspections including act as quality SME for facility control programs and post inspection activity execution
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
Qualification
Required
Bachelor's degree or Masters degree or relevant comparable background
8+ years of experience, 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 knowledge and current experience of equipment, facilities and utility validation industry trends and best practices in a cGMP 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
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