Quality Assurance Manager
1 month ago
Global Quality Manager
Location: Maidenhead, UK
Position Type: Full-time
Are you an experienced Quality Assurance professional with a strong background in GMP/GDP environments?
We are seeking a dynamic Global Quality Manager / Responsible Person to join our team based closed to Maidenhead.
This is an exciting opportunity for an individual looking to make a significant impact in a global pharmaceutical company.
About the Role:
As a Global Quality Manager, you will be an integral part of our Quality Assurance (QA) Team.
You will collaborate closely with various internal functions to support our manufacturing, storage, and distribution activities for medicinal products primarily in the EU and globally.
Your role will involve planning, executing, and documenting quality-related activities, ensuring our high standards are met for clinical trial materials, commercial products, and unlicensed medicines.
Key Responsibilities:
Serve as the Responsible Person and Responsible Person (import) for the UK.
Manage QA personnel and oversee quality control for the Manufacturer's 'Specials' Licence.
Understand and navigate legislative and regulatory requirements for importing and exporting medicines.
Support the NOI process for compliant import of unlicensed medicines into the UK.
Participate in consultancy projects and client meetings as needed.
Contribute to the development of Early Access programs.
Guide on logistical aspects of country regulations related to importing and exporting medicinal products and devices.
Address day-to-day quality questions and maintain 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 provide quality guidance.
Oversee packaging and labelling activities from a quality perspective.
Ensure compliance with lawful and ethical standards.
Suggest improvements that benefit the organization.
Achieve individual goals set by the Head of Quality.
Your Profile:
University degree in natural sciences (e.g., Biology, Biochemistry, Pharmacy) or Quality Management.
Minimum of 5 years’ experience in a GMP/GDP environment.
Experience with Clinical Trial and Early Access programs (preferred).
Extensive 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 people 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 have a forward-thinking attitude and are ready to go the extra mile, we look forward to receiving your application.
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