Site Lead

Found in: Appcast UK C C2 - 2 weeks ago

Kent, United Kingdom Meet Full time

Job Title: Site Lead

Employment Type: 12-month FTC OR Permanent (Full time)

Industry: Pharma or Med-Tech

About Us: A leading pharmaceutical/medical technology focused company dedicated to delivering high-quality products and services that improve patient outcomes globally. We are committed to maintaining the highest standards of quality and compliance in all aspects of our operations.

Job Description: We are seeking a highly skilled and experienced Site Lead (QMS) to join our team. The Site Lead will be responsible for ensuring compliance with regulatory requirements, overseeing MHRA client audits, managing our global Quality Management System (QMS), and implementing a labelling service.

Key Responsibilities:

  • Develop, implement, and maintain a comprehensive Quality Management System (QMS) to ensure compliance with regulatory standards, including MHRA requirements.
  • Lead and manage MHRA client audits, ensuring timely preparation, coordination, and follow-up activities.
  • Develop, implement, and maintain the Quality Management System (QMS) in accordance with regulatory standards such as FDA, EMA, and ISO.
  • Lead and manage a team of quality professionals responsible for ensuring compliance with quality policies, procedures, and guidelines.
  • Conduct regular audits and inspections to assess the effectiveness of the QMS and identify areas for improvement.
  • Manage and develop a team of QA professionals, providing coaching, training, and performance feedback as needed.

Requirements:

  • Bachelor's degree in a relevant scientific discipline or equivalent experience; advanced degree preferred.
  • Minimum of 8+ years of experience in Quality Assurance within the pharmaceutical or medical technology industry, with a focus on regulatory compliance.
  • Proven experience managing MHRA client audits and interacting with regulatory agencies.
  • Strong knowledge of global regulatory requirements, including MHRA regulations, FDA regulations, and ISO standards.
  • Experience developing and implementing Quality Management Systems (QMS) in a global environment.

Preferred Qualifications:

  • Experience implementing labelling services or managing labelling operations within a regulated industry.
  • Certified Quality Auditor (CQA) or equivalent certification.

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