Regulatory Compliance Director

7 days ago

London, Greater London, United Kingdom GlaxoSmithKline Full time
Job Title: Inspection Readiness Senior Director

At GlaxoSmithKline, we are seeking a highly experienced and skilled Inspection Readiness Senior Director to join our team. This role will be responsible for creating and implementing an inspection readiness strategy that ensures our sites are aligned with evolving regulatory inspection trends and expectations.

The ideal candidate will have a strong background in regulatory compliance, with a minimum of 10 years' experience leading a team accountable for GMP inspections or inspection readiness. They will be responsible for setting the strategic direction and management of the Regulatory Inspection Compliance team, preparing clear and objective reports, and mobilizing company experts to assist with inspection readiness gaps.

The Inspection Readiness Senior Director will also be responsible for driving the development of robust strategies for responding to regulatory findings and observations, managing the interface with key stakeholders, and promoting excellence and continuous improvement in inspection readiness best practices.

This is a critical role that requires a high level of expertise in regulatory compliance, leadership, and communication skills. The successful candidate will be able to work effectively with stakeholders at all levels, including senior management, and will have a proven track record of proactively identifying regulatory inspection risks.

Key Responsibilities:

  1. Develop and implement an inspection readiness strategy that ensures our sites are aligned with evolving regulatory inspection trends and expectations.
  2. Lead the Regulatory Inspection Compliance team and set the strategic direction for the team.
  3. Prepare clear and objective reports to ensure senior management and key stakeholders are apprised of inspection readiness risks.
  4. Mobilize company experts to assist with inspection readiness gaps.
  5. Drive the development of robust strategies for responding to regulatory findings and observations.
  6. Manage the interface with key stakeholders, including Site Directors and Site Quality Directors.
  7. Promote excellence and continuous improvement in inspection readiness best practices.

Requirements:

  • Minimum 10 years' experience leading a team accountable for GMP inspections or inspection readiness.
  • Strong background in regulatory compliance.
  • Proven track record of leadership and people management.
  • Highly proficient English verbal and written communication skills.
  • Expert knowledge of the existing and emerging regulatory environments in which GSK operates.
  • Demonstrated proficiency in the application and use of data analytics to predict and efficiently identify regulatory inspection readiness risks.

About Us:

GlaxoSmithKline is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology). As an Equal Opportunity Employer, we are open to all talent and believe in an agile working culture for all our roles.

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