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Director, Apheresis Quality Operations
4 months ago
Job Description
General/Position Summary
The Director, Cell & Gene Quality, International will support defining the strategy for the international expansion of Cell & Genetic programs. The role will establish the quality risk management plans, work closely with cross-functional QA, CMC, External manufacturing, Supply Chain and Commercial teams to ensure QA oversight is maintained.
Key activities include develop, lead and direct the establishment of capabilities for Operational quality managing Cell procurement, and Infusion activities at Apheresis and Infusion centers across Cell & Gene programs.
The role will closely partner with operational stakeholders to lead/support the development and execution of quality projects, quality & technical risk management including execution of associated mitigation plans, and to participate in Cell & Genetic therapies projects and governance committees for EU expansion.
This role will help build the EU/International QA compliance Apheresis expertise that supports Clinical and Commercial C&G Programs.
Key Duties & Responsibilities
- Establishment of strategic roadmap for quality oversight of VCGT ATC QA in the EU/internationally for innovative therapeutic programs.
- Support/Establish ATC Performance Management Reviews across relevant region to gain insights regarding efficiency and operational performance across the GXP operations, including identification of opportunities for improvement and associated actions.
- Serve as a QA trusted advisor/ partner with business stakeholders and as the ATC Leader for Europe and UK office.
- Establishment and maintenance of UK Human Tissue Licensing Expertise to ensure compliance requirements are met.
- For late phase programs, support initial launch and expansion requirements.
- Represent Quality in Cell & Genetic Programs for the International Expansion, participate/lead teams to meet and deliver of business & financial priorities and goals.
- Support/lead risk management activities, including mitigation plans and associated execution.
- Provides quality leadership and management for the monitoring of the regulatory and external intelligence for best practices, emerging trends and projection of future capabilities requirements to support Cell & Genetic Therapies programs.
- Support/Partner with operational stakeholders for international/EU vendor selection, qualification and oversight.
- Work closely with the Audit and Inspection Quality Function to establish the audit strategy for Auditing and Performance oversight and support technical Treatment Centers audits.
- Work closely with the cross
- functional partners to prepare for and support EU Health Authority inspections, respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions. In addition, work on providing compliance expertise that supports investigations and CAPA management.
- Create and foster a culture of collaboration, development, and engagement for advancing quality outcomes and operational excellence.
- Lead and mentor other team members, support development of organizational capabilities and talent building.
- Establish long range planning and maintain budget oversight for function.
Required Education Level
Master's degree or relevant comparable background & certifications.
Required Experience
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
Preferred Masters Degree in pharmaceutical/health sciences.
Required Knowledge/Skills
- In-depth EU ATMPs health regulatory agency knowledge, human tissue establishment licensing and experience across GXP life cycle in Cell & Gene therapy and/or Biologics.
- Broad technical knowledge Tissue licensing and Tissue regulations in the EU and US..
- Current knowledge of industry trends and best practices in Cell/Gene therapies. Medical device knowledge a plus.
- Proven expertise / experience with strategies for gene
- and cell therapy products, preparation and inspections.
- Demonstrated strategic planning and execution skills required for operational effectiveness and compliance.
- Operational Excellence experience with proven ability to lead improvement projects-Experience 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.
- Critical Thinking and Problem Solving skills
Professional membership or equivalent in relevant societies, network of knowledge in cell and gene therapy industry.
Other Requirements
~15% Travel may be required.
Hybrid-Eligible Roles
In this Hybrid-Eligible role, you can choose to be designated as:
Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility.
LI-Hybrid #LI-ND
