Sr Quality Excellence Manager Advther
il y a 1 semaine
The Senior Quality Excellence Manager, Advanced Therapies is an exempt level position. Manager's responsibilities include leading and providing quality oversight over a wide range of projects and activities within and beyond the internal & external vaccine, cell and gene therapy manufacturing facilities to support both clinical and commercial requirements. In this role you will help to establish and complete the quality strategy, lead and support critical projects to improve cycle times, out of specs (OOS) reduction, capacity expansion, stability Q&C, and cost of goods (COGs) improvement efforts.
Key Responsibilities:
- Develop, maintain, and complete Advanced Therapies Quality (ATQ) projects to enhance efficiency, reduce OOS, improve quality & compliance, reduce turnaround time, improve costs, and optimize QA & QC processes across the platform. Support the ATQ in overall management, prioritization, risk monitoring, and course corrections as required. Support implementation of a strong Project Management field and focus to complete all projects.
- Support manufacturing and QC network extension projects and enable smooth knowledge transfer between internal and external nodes to ensure consistent deployment of standards and processes in design and operational phases.
- Support deployment of a cost competitiveness focus and ensure strong continuous improvement approach. Drive and coordinate the input for the long-range financial planning (LRFP) process and identify specific needs for the ATQ network considering future network demand. Ensure strong budgetary management, both CAPEX and OPEX for QA and QC.
- Partner effectively with the various teams such as ATQ Site Quality Heads, and JJRC to facilitate deployment of network wide quality improvement initiatives/mitigations for audit trends or multi-site issues.Represent ATQ Platform in the development, planning and execution of corporate initiatives.
- Drive implementation and maintenance of the Quality Management Review (QMR) for the advanced therapy's platform; ensure that AT sites provide the vital data, information and updates for an effective QMR.
- Develop and implement the ATQ department’s critical communication initiatives to champion alignment with our objectives & engagement including communications campaigns, staff meetings, open sessions, Town Hall meetings etc.; develop content for communications that meets department needs, measure efficacy and relevance.
- Coordinate regular ATQ Leadership Team and department meetings. Incorporate recurring topics like HR/people and CREDO/DE&I.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Work under mínimal direction to complete tasks.
- Other duties may be assigned, as vital.
**Qualifications**:
**Education**:
Experience and Skills:
Required:
- A minimum of eight (8) years of experience in Quality Assurance and/or Operations related to manufacturing
- Knowledge of cGMP regulations and FDA/EU guidelines
- A strong knowledge of Quality Systems, and proven experience within a global cross-functional Quality organization
- Strong leadership capabilities, a change management champion, and an ability to lead transformation projects
- Strong verbal and written communication skills and the ability to communicate across all levels of the organization
- Excellent organizational skills across multiple work streams/fields with the ability to plan and anticipate deadlines and deliverables
- Proven track record in delivering business improvements projects; previous experience with budget and capacity planning (OPEX, CAPEX, headcount)
Preferred:
- Lean Six Sigma or other Process Excellence Certification-Experience in Biologics and/or Cell/Gene therapy
- Experience working in an aseptic manufacturing facility
Other:
- Excellent verbal and written communication skills, proficiency in English. Additional language skills are useful
- This position may require up to 15% of domestic and international travel
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