Site Name: GSK HQ, Munich, Parma, Stevenage, Tres Cantos
Posted Date: Sep 10 2024
Supplier Audit & Compliance Senior Director The role can be located anywhere in Europe or UK.
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 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.
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 that is in place and in use for all suppliers in scope for the regions, ensuring 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 in accordance with applicable standard operating procedures. Responsible for governance of SQA&C, providing governance forums with data as appropriate, representing 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 focused 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 all levels, including senior management. Highly proficient verbal and written communication skills to ensure effective relay of issues, risks, objectives, and opportunities both vertically and horizontally through the organization. Demonstrated ability to function effectively in a matrix organization, across multiple cultural and geographical boundaries. Detailed knowledge of the existing and emerging regulatory environment and a network of external contacts to help stay abreast of any changes to external expectations or the external regulatory environment. Demonstrated ability to develop and execute business strategies and lead teams to translate these into workable business processes. Preferred Qualifications: If you have the following characteristics, it would be a plus:
Masters Degree. Strong background in QC and QA systems and/or operations. Technical understanding of pharmaceutical manufacture and quality standards in a complex and scientific industry. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles.
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