Senior Quality Leader
1 month ago
Job Overview
Thermo Fisher Scientific is seeking an experienced Senior Quality Leader to lead and direct the activities of the Quality and Compliance organization. This role will be responsible for developing Quality strategy, making decisions based upon relevant data and Good Manufacturing Practices (GMPs). The successful candidate will lead the quality department through long-term transformational change.
Key Responsibilities
- Leadership and Direction: Provide overall direction and guidance to the Quality organization as a member of the Site Leadership team (SLT).
- Regulatory Compliance: Ensure the site aligns with all company policies, standards, and cGMP regulations and requirements applicable to the site.
- Quality Strategy: Set strategy and direction for the Quality organization in quality and compliance matters in alignment with Thermo Fisher's vision and goals.
- Quality Control: Ensure efficient operation of the Quality Control laboratory to support client expectations, project deliverables, and financial objectives.
- Human Resources: Ensure all elements of the people plan are carried out, including hiring, on-boarding, developing, and coaching staff and succession planning.
- PPI Business System: Support the company's Practical Process Improvement (PPI) Business System to create a culture of exceptional performance and continuous improvement.
- Regulatory Interactions: Host all Regulatory inspections and liaise with regulatory bodies such as the FDA and EMA.
- Representative: Represent the company in quality, compliance, and safety matters.
- Quality Culture: Partner with the SLT to establish and champion a Quality Culture.
- Advisory Role: Advise executive management on quality issues that may affect the site or the company as a whole.
- Performance Metrics: Establish and report Quality important metrics to monitor the business and respond to underperformance.
- Technical Support: Provide technical support to pharmaceutical sales, client sales, Pharmaceutical Development Services (PDS), Operations, and individual client groups.
- Succession Planning: Identify work behaviors to ensure an accurate succession plan and serve as a role model in alignment with Thermo Fisher Scientific values.
- Quality Decision Making: Ensure that quality is an integral part of any decision process performed by the site management.
- Quality Process Improvement: Identify, develop, and retain qualified people to lead the implementation of integrated quality processes.
- Quality Budget: Plan, handle, and prioritize the Quality budget and allocate workload and resources (system, equipment, FTEs) to meet compliance and business requirements.
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