Senior Manager, Quality Assurance and Regulatory Affairs

3 days ago

United Kingdom Emerald Lane Recruitment Full time

Senior Quality Assurance and Regulatory Affairs Manager

Part-Time/Consultant

Remote (Preference UK/EU Based)

Our client is a licensed cannabis supplier of CBD/THC products to global pharmaceutical businesses, with business operations across multiple continents.

They are seeking an experienced and dynamic Senior Quality Assurance and Regulatory Affairs Manager to join their team on a part-time basis.

This role will oversee their global quality assurance processes, manage international regulatory compliance, and interface directly with clients on all quality-related matters.

The position will be pivotal in ensuring that their products meet the highest quality standards, comply with international regulatory requirements, and satisfy client expectations. This role will work closely with their QA/QC and Regulatory Affairs teams, providing high-level oversight and strategic guidance while also acting as the primary point of contact for clients on quality issues.

The ideal candidate will have a strong background in QA management within the Cannabis industry, have extensive knowledge of EU-GACP and EU-GMP standards, and experience in regulatory affairs across multiple jurisdictions (preferably EU / Australia).

Fluency in Spanish(B2+) is strongly preferred.

This role is fully remote, with the individual ideally based in the UK/Europe.

Part-time commitment to start (1-2 days/week + ‘on-call’ support).

RESPONSIBILITIES:

  • Quality Assurance Oversight
  • Provide high-level oversight of the entire Quality Assurance function, ensuring compliance with EU-GACP, EU-GMP, and other relevant international standards.
  • Mentor and guide the QA/QC team, ensuring that day-to-day operations align with global best practices.
  • Conduct periodic audits and reviews of QA processes to ensure continuous improvement and adherence to regulatory standards.

  • Client Quality Interface:
  • Act as the primary point of contact for clients on all quality-related matters, addressing inquiries, handling complaints, and ensuring client satisfaction.
  • Draft, review, and negotiate Quality Technical Agreements (QTAs) with clients, ensuring all quality obligations are clearly defined and met.
  • Work closely with the sales and production teams to ensure that client-specific quality requirements are understood and implemented.

  • Regulatory Affairs Management:
  • Manage the regulatory affairs function, ensuring that all medical cannabis products meet the regulatory requirements of the countries in which they operate, notably EU, UK, Australia and other markets.
  • Monitor international regulatory changes and ensure timely compliance with new regulations.
  • Interface with the Regulatory Affairs team to coordinate efforts and maintain alignment between both local and international regulatory requirements.

QUALIFICATIONS:

  • Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or a related field. Advanced degree (Master’s or PhD) preferred.
  • 5+ years of experience in Quality Assurance, Regulatory Affairs, or a related field, preferably in the pharmaceutical, biotech, or medical cannabis industries.
  • Strong knowledge of EU-GACP, EU-GMP, and other relevant international standards.
  • Proven experience in managing regulatory affairs ideally for medical cannabis across multiple jurisdictions (EU, AUS).
  • Experience interfacing with clients on quality-related issues is highly desirable.
  • Fluency in Spanish (B2+) is strongly preferred.

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