Senior Quality Assurance Executive

3 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 enhance our team.

This role presents an exceptional opportunity for an individual eager to contribute significantly within a global pharmaceutical organization.

Role Overview:

As a Global Quality Manager, you will play a crucial role in our Quality Assurance (QA) Team.

Your collaboration with various internal departments will be essential to support our manufacturing, storage, and distribution operations for medicinal products, primarily across the EU and globally.

Your responsibilities will include planning, executing, and documenting quality-related initiatives, ensuring that our high standards are consistently met for clinical trial materials, commercial products, and unlicensed medicines.

Key Responsibilities:

  • Act as the Responsible Person and Responsible Person (import) for the UK.
  • Oversee QA personnel and manage quality control for the Manufacturer's 'Specials' Licence.
  • Comprehend and navigate legislative and regulatory requirements for the import and export of medicines.
  • Support the NOI process for compliant importation of unlicensed medicines into the UK.
  • Engage in consultancy projects and client meetings as necessary.
  • Contribute to the development of Early Access programs.
  • Provide guidance on logistical aspects of 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 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.
  • Experience with Clinical Trial and Early Access programs is preferred.
  • Comprehensive knowledge of GMP, GDP, and associated 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 team members. If you possess a forward-thinking attitude and are ready to contribute, we look forward to your application.

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