Quality Assurance Director

4 weeks ago


London, Greater London, United Kingdom GlaxoSmithKline Full time

Quality Regulatory Excellence Director

This is a truly exciting position for the Quality Regulatory Excellence Director to deliver on regulatory conformance processes and activities across GSK's medicine and vaccines manufacturing sites and External Supply network.

This role will provide a central focus and drive for continuous improvement, building capability, and driving harmonization in accountability and function across regulatory conformance teams.

Key Responsibilities:

  • Serve as the accountable GSK Quality lead for regulatory conformance business processes, risk and issue management, and continuous improvement for sites, external supply, and LOCs.
  • Develop and implement efficient business processes for managing regulatory information, including regulatory change control management, to support SKU management and batch release.
  • Define and implement GSC strategies to meet new country requirements, such as additional testing in Korea and site data for Kenya.
  • Lead regulatory conformance activities for sites and external supply to support compliance and improvement projects, including training curricula development, remediation programs, and data integrity initiatives.
  • Chair the GSC Regulatory Conformance Community of Practice and Steering Team.
  • Enhance site capability for regulatory conformance, disseminate knowledge of global regulations and guidance across the network, and trend key performance indicators for regulatory conformance business processes.

Requirements:

  • Degree qualified in scientific or engineering discipline or able to demonstrate equivalent level of knowledge
  • Significant regulatory compliance experience in medicines/vaccines manufacture and release
  • Detailed knowledge of global regulations and guidance, global regulatory expectations, industry standards and risks pertaining to regulatory conformance processes.
  • Excellent understanding of Pharmaceutical Quality Systems and QMS
  • Considerable quality experience in pharma industry or process development environment (manufacturing, quality control, quality assurance, external supply)
  • Demonstrated experience managing and improving quality systems, including project management elements
  • Proven experience interfacing and influencing senior Global Leadership team stakeholders
  • Strong leadership skills
  • Ability to lead cross functional project and/or matrix teams to an aligned strategy

Preferred qualifications and skills:

  • BA/BS or Masters Degree
  • Excellent oral and written communication skills
  • Excellent interpersonal skills, including the ability to interact/influence/negotiate effectively at all levels of management and peers.
  • Deep knowledge and experience in operational excellence / continuous improvement techniques and deployment
  • Experience and comfort working with digital systems


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