Sr Quality System Manager

il y a 1 semaine

Le PontdeClaix, France BD Temps plein

**Job Description Summary**: The Sr Quality System Manager leads One PS Quality System strategy through excellence leveraging on inspire Quality central team initiative:
Simplify, harmonize, integrate, while ensuring compliance and efficiency of the PS ways of working with a strong and inspiring Quality culture.

This position is accountable to build PS way of working, establish plans, engaging with business process owners, sites and central teams, and ensure successful implementation of the defined strategy.

Responsible for developing and maintaining strategic quality and compliance plans leveraging on iQ and integrating all PS activities and sites.

Engage and provide leadership directions/objectives within PS.

Build an effective and influential network of communication with business process owners, worldwide functions, plants/sites leadership and Central Teams.
- Develop the integration strategy and plans for each site
- Identify and mitigate associated risks
- Follow through with the deliverables of the plans.
- Ensure on time and successful PS iQ program implementation, supporting iQ program leader
- Develop a cohesive team, maintaining and reinforcing a strong quality culture.
- Deploy quality awareness and culture through consistent, impactful, continuously evolving training and communication plan
- Oversee Training developer and is ultimately accountable to Provide GxP and Quality Management Systems awareness and education among PS sites to drive comprehensive and efficient simplification program
- Oversee PDC Campus QS Leader and is ultimately accountable for ensuring the health and efficiency of the quality system maintained at Pont-de-Claix Campus (France) by managing proactive and reactive programs and ensuring compliance to regulations and standards.
- Oversee Training and Qualification Business Process Owner (BPO) and is ultimately accountable for the Training and Qualification process for BDM Pharmaceutical Systems and supports implementation across all Manufacturing Sites & Design Centers.
- Provide support for internal and external audits at other sites
- Stays up to date on the regulatory environment and customer expectations

**Primary Work Location**: FRA Le Pont-de-Claix Cedex

**Additional Locations**: USA NJ - Franklin Lakes

**Work Shift**:

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