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Senior Director of Regulatory Inspection Readiness

2 months ago

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

We are seeking a highly experienced and skilled Inspection Readiness Senior Director to join our team at GSK. As a key member of our organization, you will be responsible for creating and deploying inspection readiness strategies across the GSK network.

The ideal candidate will have a deep understanding of global regulatory requirements and a proven track record of leading teams accountable for GMP inspections and inspection readiness. You will be responsible for ensuring GSK is aligned with or ahead of evolving regulatory inspection trends and expectations.

Key Responsibilities:

  • Develop and implement inspection readiness strategies to ensure GSK sites are prepared for regulatory inspections
  • Lead a team of regulatory inspection compliance experts to assist sites with inspection readiness, including pre-, during, and post-inspection support
  • Prepare clear and objective reports to inform senior management and stakeholders of inspection readiness risks and opportunities
  • Mobilize company experts to assist in investigating and resolving inspection readiness gaps
  • Provide support to the FDA in scheduling international inspections and assist during inspections as needed
  • Drive the development of robust strategies for responding to regulatory findings and observations
  • Manage the interface with key stakeholders, including site directors and quality directors
  • Develop inspection readiness capabilities at highly regulated sites through proactive knowledge sharing and collaboration
  • Promote excellence and continuous improvement in inspection readiness best practices and processes
  • Train and coach site SMEs in preparation for external inspections
  • Own QMS policies and processes associated with inspection readiness
  • Lead the Inspection Readiness Community of Practice
  • Share key learnings and findings from significant regulatory inspections across GSK
  • Manage the Regulatory Inspection Compliance team budget
  • Motivate and develop the Regulatory Inspection Compliance team

Requirements:

  • BA/BS degree or equivalent in chemistry, pharmacy, biological sciences, or related field
  • Detailed knowledge of global cGMPs, regulatory guidances, and quality management systems
  • Minimum 10 years' experience leading a team accountable for GMP inspections or inspection readiness
  • GMP inspector experience with a major regulatory authority
  • Proven track record of leadership and people management
  • Highly proficient English verbal and written communications skills
  • Ability to function effectively in a matrix organization
  • Expert knowledge of regulatory environments and data analytics
  • Broad-based familiarity with primary, secondary manufacturing, and biopharmaceuticals

Why GSK?

GSK is a global biopharma company committed to uniting science, technology, and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty, and general medicines. We focus on the science of the immune system and the use of new platform and data technologies.

We are an equal opportunity employer and adhere to affirmative action principles. We believe in an agile working culture and offer a range of benefits to support our employees' wellbeing and career development.