Regulatory Inspection Compliance Director
2 weeks ago
We are seeking a highly experienced Regulatory Inspection Compliance Director to join our team at GlaxoSmithKline. As a key member of our organization, 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 manage the strategic direction of the Regulatory Inspection Compliance team, providing support to GSK sites with inspection readiness, including pre-, during, and post-inspection assistance.
- Prepare clear and objective reports to inform senior management and key stakeholders of inspection readiness risks, enabling timely corrective action plans.
- Mobilize company experts to assist in investigating and resolving inspection readiness gaps, ensuring compliance with regulatory requirements.
- Collaborate with key stakeholders, including Site Directors and Site Quality Directors, to drive inspection readiness capability at highly regulated sites.
- Develop and implement robust strategies for responding to regulatory findings and observations, providing oversight and assistance during the regulatory response drafting process.
- Manage the interface with regional functions and stakeholders, ensuring effective communication and collaboration.
- Drive excellence and continuous improvement in inspection readiness best practices and processes.
- Train and coach site SMEs in preparation for external inspections, enabling the best possible outcomes for each site.
- Own QMS policies and processes associated with Inspection Readiness, ensuring compliance and effectiveness.
- Lead the Inspection Readiness Community of Practice, fostering knowledge sharing and collaboration across the organization.
- Share key learnings and findings from significant regulatory inspections, promoting a culture of continuous improvement.
- Manage the Regulatory Inspection Compliance team budget, ensuring timely and effective resource allocation.
- Motivate and develop the Regulatory Inspection Compliance team, promoting a culture of excellence and continuous improvement.
- Minimum 10 years' experience leading a team accountable for GMP inspections or inspection readiness in a research-based pharmaceutical company.
- GMP inspector experience with a major regulatory authority, such as the US FDA, UK MHRA, or EMA.
- Proven track record of leadership and people management, with demonstrated ability to work with and influence stakeholders at all levels.
- Highly proficient English verbal and written communications skills, with ability to effectively relay issues, risks, objectives, and opportunities across the organization.
- Expert knowledge of the existing and emerging regulatory environments, with a proven track record of identifying regulatory inspection risks.
- Demonstrated proficiency in data analytics to predict and efficiently identify regulatory inspection readiness risks.
At GlaxoSmithKline, we are committed to unifying science, technology, and talent to get ahead of disease together. We believe in an agile working culture and are an Equal Opportunity Employer, open to all talent.
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Regulatory Inspection Compliance Director
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London, Greater London, United Kingdom GlaxoSmithKline Full timeJob Title: Inspection Readiness Senior DirectorAt 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...
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London, Greater London, United Kingdom GlaxoSmithKline Full timeJob Title: Inspection Readiness Senior DirectorAt 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...
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