Senior Director of Supplier Quality and Compliance

hace 3 días

Madrid, Madrid, España Gsk A tiempo completo
Job Purpose:
The purpose of this 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 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 the 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, 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.

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.

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