Regulatory Compliance Expert

5 days ago


Stevenage, Hertfordshire, United Kingdom Jas Gujral Full time
Regulatory Compliance Expert - Project Support

Estimated Salary: £60,000 - £80,000 per annum

About Us

Jas Gujral is a trusted partner in the industry, committed to excellence in quality management. Our team works tirelessly to ensure the delivery of high-quality products and services.

Job Summary

We are seeking a highly experienced Regulatory Compliance Expert to join our team. The successful candidate will be responsible for ensuring compliance with regulatory authorities and collaborator standards. Key responsibilities include:

  • Leading a multi-disciplinary team to maintain a compliant facility.
  • Coordinating Quality interactions with third-party contractors.
  • Participating in regulatory agency and client inspections.
  • Maintaining PQS in a fit-for-purpose state of control for a multi-purpose, multi-client facility.
  • Providing quality subject matter expertise to expansion project teams.
  • Promoting awareness of quality requirements and supporting quality culture evolution throughout the organization.
Requirements

The ideal candidate will have:

  • 5-10 years of experience in a clinical environment.
  • A proven track record as a Quality Specialist or equivalent in biologics and preferably cellular and/or gene therapies.
  • In-depth knowledge of EMA and FDA regulatory environments and requirements.
  • Familiarity with global standards related to quality.
Career Development

We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.



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