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Senior Director of Regulatory Compliance

2 months ago

London, Greater London, United Kingdom VONQ Full time
Job Summary

VONQ is seeking a highly experienced Senior Director of Regulatory Compliance to lead our inspection readiness efforts. As a key member of our team, you will be responsible for ensuring our organization is aligned with evolving regulatory inspection trends and expectations.

Key Responsibilities
  • Develop and implement a comprehensive inspection readiness strategy to ensure compliance with regulatory requirements.
  • Lead a team of regulatory compliance experts to assist 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 risks prior to an inspection.
  • Mobilize company experts to assist in investigating and resolving inspection readiness gaps prior, during, and post-inspection.
  • Provide support, as necessary, in the inspection room during international inspections.
  • Drive the development of a robust strategy for responding to regulatory findings/observations and provide oversight and assistance during the regulatory response drafting process.
  • Manage the interface with key stakeholders, including site directors and quality directors, and regional functions where appropriate.
  • Develop inspection readiness capabilities at highly regulated sites through proactive knowledge sharing and collaboration.
  • Promote excellence and continuous improvement associated with inspection readiness best practices and processes.
  • Train and coach site subject matter experts in preparation for external inspections to enable the best possible outcome for each site.
  • Own QMS policies and processes associated with inspection readiness.
  • Lead the inspection readiness community of practice.
  • Accountable for timely and effective sharing of key learnings and findings/observations from significant regulatory inspections across the organization.
  • Responsible for the generation and monitoring of the regulatory compliance team budget.
  • Accountable for motivating the regulatory compliance team, keeping the team focused, and promoting development within the team to ensure the right future-ready capabilities and succession plans.
Requirements
  • BA/BS degree or equivalent in experience (chemistry, pharmacy, biological sciences, science-related).
  • Detailed knowledge of worldwide cGMPs, associated regulatory guidelines, and expectations, and quality management systems for pharmaceuticals, APIs, biopharmaceuticals, medical devices, and steriles.
  • Minimum 10 years' experience leading a team accountable for the conduct of GMP inspections on behalf of a major regulatory authority (e.g., US FDA, UK MHRA, EMA) and/or a team accountable for the inspection readiness of a research-based pharmaceutical company manufacturing pharmaceuticals, APIs, biopharmaceuticals, medical devices, and steriles.
  • GMP inspector experience with a major regulatory authority such as FDA but could also be MHRA (the UK regulator), HPRA (the Irish regulator), EMA (the EU regulator, etc).
  • Proven track record of leadership and people management with demonstrated ability to work with and influence stakeholders at all levels, including senior-most management.
  • 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.
  • Demonstrated ability to function effectively in a matrix organization, across multiple cultural and geographical boundaries.
  • Expert knowledge of the existing and emerging regulatory environments in which VONQ operates with a proven track record of proactively identifying regulatory inspection risks within those environments.
  • Demonstrated proficiency in the application and use of data analytics to predict and efficiently identify regulatory inspection readiness risks.
  • Broad-based familiarity with primary, secondary manufacturing, and biopharmaceuticals, sterile manufacturing.