Supplier Audit and Compliance Senior Director
Vor 4 Tagen
**Site Name**: GSK House, Munich, Parma, Stevenage, Tres Cantos
**Posted Date**: Jun 24 2024
We’re excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we’re building an energising space where we can connect, collaborate and get ahead of disease together. Designed especially for us, it’ll be one of the healthiest workplaces in the world, with best-in-class tech and bright, light spaces to help us thrive.
**Supplier Audit & Compliance Senior Director**:
The role can be located anywhere in Europe or UK
**The deadline for the job posting is the 15th of July in 2024**:
We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 2.3 billion packs of medicines and doses of vaccines in 2023.
We continue to modernise, so we can launch even more new products at speed whilst continuing to deliver across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.
**Job purpose**:
The purpose of this job role is to provide leadership and design the strategy for Supplier Quality Audit & Compliance (SQ A&C) to ensure that all material and service suppliers within the scope of SQA&C are audited and managed appropriately regarding compliance with applicable external regulatory requirements and expectations and GSK requirements.
**Key responsibilities**:
- Accountable for setting the strategic direction of the SQA&C organisation and for managing the team in a manner that fosters continuous improvements to the ways of working and processes
- Accountable for maintaining a robust supplier audit program is in place and in use for all suppliers in scope for the regions and that the program is in alignment with GSK Quality Standards and departmental procedures
- Define and endorse SQA&C audit standards for types of suppliers within role scope and ensure alignment with GSK Quality Management System (QMS), as appropriate
- Provide support and oversight to SQA&C audits conducting the assessment/audit of suppliers, including service providers within scope of the role.
- Closely collaborate with senior stakeholders in External Supply Quality, External Supply, and other key stakeholders, to proactively identify risks and potential risks and work together to devise strategies to mitigate any such risks or potential risks
- Ensure that decisions regarding marginal (Conditionally Approved, Not Approved) in-use suppliers are appropriately documented, communicated, controlled, and managed via in accordance with applicable standard operating procedures
- Responsible for governance of SQA&C, providing governance forums with data as appropriate, represent SQA&C/ A&C at tiered governance meetings. Deputise for VP QA&C as required
- Ensure any learnings from SQAC or supplier identified incidents are communicated across SQA&C, QAC and GSK, as applicable
- Accountable for motivating the SQ&C team, keeping the team focus and promoting development within the team to ensure the right future ready capabilities and succession plans
**Basic Qualifications**:
- BA/BS degree or equivalent in experience (Chemistry, pharmacy, biological sciences, science related)
- Detailed knowledge of world-wide cGMPs, associated regulatory guidances and expectations and Quality Management Systems for pharmaceuticals, APIs, biopharmaceuticals, medical devices, steriles
- Minimum 10 years’ experience leading a team accountable for the conduct of supplier audits on behalf of a multi-national pharmaceutical company involved in the manufacture of pharmaceuticals, APIs, biopharmaceuticals, medical devices and steriles
- GSK Certified Auditor (or progressing through the programme) or Accreditation from External Quality or Regulatory Professional Organization (i.e. Regulatory Affairs Professional Society Certification (RAC), ASQ (Quality Auditor Certification)
- Proven track record of leadership and people management with demonstrated ability to work with and influence stakeholders at levels, including senior most management
- Highly proficient verbal and written communications skills to ensure effective relay of issues, risks, objectives and opportunities both vertically and horizontally through the organization so that these are well understood by all parties and effective action plans can be put in place
- Demons
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