Director QA, GMP External Operations Cell and Genetic Therapies - VCGT

General/Position Summary

The Director , Quality Assurance GMP Operations is responsible for the applicable Cell & Gene CDMO and is responsible for the end to end quality oversight of all product and activities at the CDMO. Responsibilities include day-to day operational quality oversight including assuring progression of batch record operations , resolution and on time disposition of product, quality continuous improvements, changes associated with the process and associated implementation, trends, and overall quality performance of the CDMOs .

The role will closely partner with operational stakeholders to lead/support the development and execution of quality & technical risk mitigation, execution of operational activities and participat ion in governance committees . A key expectation is the ability to closely collaborate and build relationships with internal and external stakeholders to drive compliance and continuous improvement activities . The role may also be required to support on site manufacturing activities at the CDMO .

• Establishment of quality oversight for external C T O/C D MO operations including assurance of on time of batch disposition process , across development, launch and commercial manufacturing globally.
• Lead, Develop, and implement continuous quality improvements to a dvanc e quality outcomes and operational excellence in processes.
• Proactively develop Compliance metrics as key indicators and takes action to mitigate .
• Maintain full oversight of CDMO QMS including driving deviation reduction and assuring timely resolution of CAPAs.
• Act as the SME for the CDMO , understanding scope of all changes, driving applicable global change control implementation with the external manufacturing partner to meet global product goals.
• Represent Quality and serve as a trusted partner for the disposition activities of drug product.
• Build strategic relationships and foster a culture of collaboration with internal and external partners – CDMOs and CTOs within the Quality organization to ensure Quality issues are raised and addressed, as necessary.
• L ead/support the development of quality & technical risk mitigation through identification and mitigation compliance gaps .
• Lead and mentor other team members, support development of organizational capabilities and talent building.
• Act as the batch disposition subject matter expert (SME) in support of regulatory inspections and audits.
• Establish /parti ci pate 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.
• Work closely with the cross- functional partners to prepare for and support Health Authority inspections, respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions.
• 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.
• May be required to support manufacturing on site activities.

Batchelor 's degree or relevant comparable background.

Masters preferred.

10 + 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 21

CFR Part 1271, GxPs ).

Broad and c urrent knowledge of batch disposition industry trends and best practices in Cell/Gene therapies.

Preferred 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. P roven ability with Root Cause Analysis,…