International Quality Control Manager

4 weeks ago

Maidenhead, Windsor and Maidenhead, United Kingdom Meet Full time

Global Quality Manager

Location: Maidenhead, UK

Position Type: Full-time

Are you a seasoned Quality Assurance expert with a robust background in GMP/GDP settings?

We are looking for a proactive Global Quality Manager / Responsible Person to become a key member of our team.

This role presents an exceptional opportunity for an individual eager to make a meaningful contribution within a worldwide pharmaceutical organization.

About the Role:

In the capacity of Global Quality Manager, you will play a vital role within our Quality Assurance (QA) Team.

Your responsibilities will involve close collaboration with various internal departments to enhance our manufacturing, storage, and distribution processes for medicinal products, focusing primarily on the EU and global markets.

Your duties will encompass planning, executing, and documenting quality-related initiatives, ensuring that our stringent standards are upheld for clinical trial materials, commercial products, and unlicensed medicines.

Key Responsibilities:

  • Act as the Responsible Person and Responsible Person (import) for the UK.
  • Supervise QA personnel and manage quality control for the Manufacturer's 'Specials' Licence.
  • Comprehend and navigate the legislative and regulatory frameworks for the import and export of medicines.
  • Facilitate the NOI process for compliant importation of unlicensed medicines into the UK.
  • Engage in consultancy projects and client meetings as required.
  • Contribute to the formulation of Early Access programs.
  • Provide guidance on logistical aspects concerning country regulations related to the import and export of medicinal products and devices.
  • Address daily quality inquiries and maintain the qualification status of customers, suppliers, vendors, and clients.
  • Review and develop Standard Operating Procedures (SOPs) and quality agreements.
  • Assist in the preparation and submission of license applications and variations in the UK.
  • Manage change controls, deviations, and offer quality guidance.
  • Oversee packaging and labeling activities from a quality assurance perspective.
  • Ensure adherence to lawful and ethical standards.
  • Propose enhancements that benefit the organization.
  • Achieve individual objectives set by the Head of Quality.

Your Profile:

  • University degree in natural sciences (e.g., Biology, Biochemistry, Pharmacy) or Quality Management.
  • At least 5 years of experience in a GMP/GDP environment.
  • Familiarity with Clinical Trial and Early Access programs (preferred).
  • Extensive knowledge of GMP, GDP, and related regulations.
  • Business fluency in English.
  • Pragmatic quality mindset with a company-wide perspective.
  • Proactive team player with innovative ideas.

Why Join Us?

We believe that investing in talented individuals creates value for our customers, employees, suppliers, and the communities in which we operate.

Our success is driven by the motivation, dedication, and performance of our people. If you possess a forward-thinking attitude and are prepared to go the extra mile, we look forward to your application.

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