1. Purpose and Scope of Position:
The Celgene manufacturing site of Boudry is a Center of Excellence for New Product Introduction and flexible production of Oral Solid Dosage Drugs. The New Product Introduction (NPI) Quality Representative is part of the Quality Operations team of Celgene, Switzerland. He/She is accountable for the Quality oversight of the operations accomplished in the frame of the new product introduction process, covering also Quality Control for the Boudry site as well as, if needed, the Couvet sites.
The position is responsible for driving and coordinating all quality aspects related to the NPI activities.The core mission is to guarantee all of the quality aspects are efficiently managed within the NPI for ensuring compliant and robust compliance to Celgene Policies, Standard Operating Procedures, and regulations. The position is also responsible for reinforcing a continuous improvement mindset within the quality organization & partners, and in charge of some specific Quality Operations duties.
This position is primarily located at the Celgene site in Boudry.
2. Required Competencies: Knowledge, Skills, and Abilities:
* At least 10 years' experience in Quality Assurance and/or Quality Control in a pharmaceutical/biotechnology industry.
* Thorough understanding of GMPs, and EMA, Swissmedic, and FDA regulatory requirements.
* Demonstrated experience in Regulatory strategies and tactics.
* Solid knowledge in project management.
* Good knowledge of all phases of the global drug development process and clinical trial data flow.
* Demonstrated ability to build relationships and foster team cohesion.
* Excellent management and negotiation skills.
* Demonstrated experience in Lean Manufacturing culture and visual management.
* Ability to motivate and engage teams across functions.
* Excellent written, communication skills, .and organizational skills.
3. Duties and Responsibilities
New product Introduction:
* Act as the Quality Operations representative, i.e QA, QC, compliance, and systems, within the NPI project teams by leading all of the quality aspects.
* Responsible for ensuring on time if full the quality aspects compliant deliveries, regarding the NPI projects implementation.
* Lead a lean transfer from development to operations.
* Responsible for the transfer from launching manufacturing sites to operational site.
* Monitor the best practices both internally and external, through comprehensive benchmarking, defines the implementation strategies and roll out.
* Manage the quality aspects' coordination with internal/external stakeholders such as development, AS&T, MS&T, PMO, manufacturing.
* Responsible for alignment between internal manufacturing sites.
* Act a Site QA Liaison for support to regulatory submissions.
* Participate actively to inspections / audits site readiness.
* Responsible for the management of the continuous improvement plan for the Site Quality Operations in collaboration with the GIM OE team, and global OE.
* Promote a continuous improvement.
* Works closely together with the other stakeholders to ensure improvement and alignment of the Quality Management Systems.
* Responsible for measuring benefits and sustainability.
* Participate actively to the lifecycle of the strategic site Quality operation plan with cooperation with stakeholders.
* Support the development of a meaningful KPI structure as a basis for continuous improvement.