Vertex · 22 hours ago
GMP Operational Quality Senior Manager
Boston, MA
Full-time
Onsite
Senior Level, Lead/Staff
$136K/yr - $205K/yr
8+ years expVertex is a global biotechnology company that invests in scientific innovation. They are seeking a Senior Manager, GMP Quality Operations who will be responsible for maintaining compliance in quality assurance and overseeing batch records for production. The role involves collaboration with internal and external stakeholders to ensure product safety and operational excellence.
Computer Software
Responsibilities
Author SOP's to support commercial quality functions
Assist with regulatory agency inspections
Ensuring that Master Batch Records are managed to maintain compliance over the life cycle
Identify and facilitate continuous improvement efforts
Managing the issuance of BPRs, ensuring only authorized, current versions are printed for production
Maintaining logs for the issuance, return, and reconciliation of batch records to prevent misuse and ensure accountability
Ensure audit readiness: Maintaining organized, accessible documentation for regulatory inspections
Establishment of quality oversight for internal quality and external CDMO operations for the batch disposition process, across development, launch and commercial manufacturing
Manage the day-to-day timely release of finished product to ensure compliance with Regulatory and Vertex cGMP requirements
Assure disposition activities across CGT Therapy related products manufacturing are compliant and consistent
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, respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions
Identify and communicate risks and assist with risk mitigation plans as necessary
Represent Quality to lead/participate in complex projects and partner with key stakeholders for alignment in strategic and operational planning
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
Lead and mentor other team members, support development of organizational capabilities and talent building
Manage the department resources with regards to budget and personnel
Build strategic relationships with internal and external partners – CDMOs within the Quality organization to ensure Quality issues are raised and addressed, as necessary
Qualification
Required
Bachelor's degree or Masters degree relevant comparable background
8+ 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
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
Represents job field similar to this job
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