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Senior Director of Regulatory Inspection Compliance
2 months ago
GlaxoSmithKline is seeking a highly experienced Senior Director of Regulatory Inspection Compliance to join our team. As a key member of our Quality Management Systems team, you will be responsible for creating and implementing inspection readiness strategies to ensure our sites are aligned with evolving regulatory inspection trends and expectations.
Key Responsibilities:- Develop and implement inspection readiness strategies to ensure compliance with regulatory requirements.
- Lead the Regulatory Inspection Compliance team in assisting GSK sites with inspection readiness, including providing support pre-, during, and post-inspection.
- Prepare clear and objective reports to ensure senior management and key stakeholders are apprised of any inspection readiness risk prior to an inspection.
- Mobilize company experts to assist investigating and resolving inspection readiness gaps prior, during, and post the inspection.
- Provide support, as necessary, in the Inspection Room during international FDA inspections.
- Drive development of robust strategy for responding to any regulatory findings/observations and provide oversight and assistance during the regulatory response drafting process.
- Manage the interface with key stakeholders including Site Directors and Site Quality Directors, and regional functions where appropriate.
- Develop inspection readiness capability at highly regulated sites through proactive knowledge sharing and collaboration.
- Promote excellence and continuous improvement associated with inspection readiness best practice and processes.
- Training and coaching of site SME's in preparation for external inspections to enable the best outcome possible for each site.
- Owner of QMS policies and processes associated with Inspection Readiness.
- Accountable for leading the Inspection Readiness Community of Practice.
- Accountable for timely and effective sharing of key learnings and findings/observations from significant Regulatory Inspections across GSK.
- Responsible for the generation and monitoring of the Regulatory Inspection Compliance team budget.
- Accountable for motivating the Regulatory Inspection Compliance team, keeping the team focus and promoting development within the team to ensure the right future ready capabilities and succession plans.
This is an exciting opportunity to join a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together. As an Equal Opportunity Employer, we are open to all talent and believe in an agile working culture for all our roles.
We are committed to diversity and inclusion and welcome applications from all qualified candidates. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.
