GMP Operational Quality Senior Manager (Quality Engineering/Validation)

Vertex Inc.•Boston, MA

10d•Onsite

About The Position

The Senior Manager, Quality Assurance Technical Services will execute and provide quality support and oversight for Quality Engineering and Validation programs at Vertex Cell and Genetic Therapies sites. This role is responsible for executing QA activities for validation of equipment and systems, facility and equipment change controls, CAPAs, validation-related deviations, and all validation lifecycle documentation. Furthermore the role will support the calibration and Maintenance program QA oversight activities. Acting as a trusted advisor, the Senior Manager will collaborate with site operation business partners to ensure compliance, address quality issues, and drive continuous improvement. This is a 5 days on site role located in the Seaport, Boston.

Requirements

Batchelor'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.
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.

Nice To Haves

QA Operational experience for Autologous Cell Therapy Operations.
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.

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.