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Senior Director of Supplier Quality and Compliance
hace 2 meses
The Senior Director of Supplier Quality and Compliance will provide leadership and strategic direction for the Supplier Quality Audit and Compliance (SQ A&C) organization. This role is responsible for ensuring 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 organization 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 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.
- 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.
- 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 team to translate these into workable business processes.
