Regulatory Inspection Compliance Director
4 days ago
At GlaxoSmithKline, we are committed to uniting science, technology, and talent to get ahead of disease together. We are seeking an experienced Inspection Readiness Senior Director to join our team and play a key role in ensuring our sites are inspection-ready.
The successful candidate will be responsible for creating and implementing an inspection readiness strategy that aligns with evolving regulatory inspection trends and expectations. This will involve setting the strategic direction for the Regulatory Inspection Compliance team, preparing clear and objective reports for senior management and key stakeholders, and mobilizing company experts to assist with inspection readiness gaps.
The ideal candidate will have a minimum of 10 years' experience leading a team accountable for the conduct of GMP inspections on behalf of a major regulatory authority or a team accountable for inspection readiness of a research-based pharmaceutical company. They will also have a proven track record of leadership and people management, with demonstrated ability to work with and influence stakeholders at all levels.
The Inspection Readiness Senior Director will be responsible for:
- Developing and implementing an inspection readiness strategy that aligns with evolving regulatory inspection trends and expectations.
- Preparing clear and objective reports for senior management and key stakeholders.
- Mobilizing company experts to assist with inspection readiness gaps.
- Providing support and guidance to sites on inspection readiness.
- Driving development of robust strategy for responding to regulatory findings/observations.
- Managing the interface with key stakeholders, including Site Directors and Site Quality Directors.
- Developing inspection readiness capability at highly regulated sites.
- Promoting excellence and continuous improvement associated with inspection readiness best practice and processes.
- Training and coaching of site SMEs in preparation for external inspections.
- 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 focused and promoting development within the team to ensure the right future-ready capabilities and succession plans.
The successful candidate will have a deep understanding of world-wide cGMPs, associated regulatory guidances and expectations, and Quality Management Systems for pharmaceuticals, APIs, biopharmaceuticals, medical devices, and steriles. They will also have highly proficient English verbal and written communication skills to ensure effective relay of issues, risks, objectives, and opportunities both vertically and horizontally through the organization.
We are an Equal Opportunity Employer and welcome applications from all qualified candidates. We believe in an agile working culture for all our roles.
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