Global Head of Quality
3 weeks ago
RRxCo is partnered with a Life Science Organisation in the search for a Global Head of Quality.
Deliverables
- To lead the build and continual development of the QMS to Quality standards
- Be the lead SME for Quality & Compliance related issues
- To shape, provide line management and run the Quality team
- To hold and be responsible for the departmental budget, including team training and development
- Be accountable and lead a programme of work that will keep the organisation in a compliant state and within regulatory guidelines
- Be the main point of contact for authorities with oversight and execution for preparation, leading and running of major inspections and audits (internal and external)
- To establish and evolve a strategy that will support the business growth with effective resources including workload, project assignment and cross-functional collaboration
- To build and maintain relationships with external vendors, customers and collaborators
- To establish relationships with the Executive Leadership group to support the short-to-long-term strategy of the entire business
- Mould the Quality organisation into an effective and well-resourced business unit
Profile of the individual
- Degree qualified, ideally PHD and/or MBA within a relevant Scientific, Quality Management, or Engineering field
- Expertise and proven working experience with current ISO9001:2015 and ISO13485 standards
- Industry experience in a Quality role and in a Senior Leadership position (department head)
- Experience of running a medium-sized Life Science organisation
- Well-developed understanding of Quality & Compliance strategies, tactics, processes and development
- Ideally, past or current experience working within a global or regional level post in a Life Science organisation (primarily a Medical Device organisation)
- Has acted as the point of contact and led meetings/audits/inspections with Authorities
- Past experience working in a global organisation across a wide variety of time zones
- High attention to detail
- Strong history of, and skills in, coaching and motivating teams
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