Global Head Of Quality in The Point

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