Pharmaceutical Compliance Manager
1 day ago
We are searching for a Quality Management Leader to oversee our QA operations in the UK.
This is a challenging opportunity for an experienced professional to take on a leadership role in our Quality Assurance (QA) Team and contribute to our growth in the global pharmaceutical market.
Your primary responsibilities will include ensuring compliance with regulatory requirements for clinical trials, commercial products, and unlicensed medicines across multiple regions.
About the Position:You will work closely with internal departments to support manufacturing, storage, and distribution activities mainly in the EU and globally.
In this critical role, you will serve as the Responsible Person and Responsible Person (import) for the UK, overseeing QA personnel and quality control for the Manufacturer's 'Specials' Licence.
Duties:- Supervise QA personnel and oversee quality control for the Manufacturer's 'Specials' Licence.
- Analyse complex legislative and regulatory requirements for importing and exporting medicines.
- Coordinate the NOI process for compliant import of unlicensed medicines into the UK.
- Participate in consultancy projects and client meetings as required.
- Contribute to the development of Early Access programs.
- Offer guidance on logistical aspects of country regulations related to importing and exporting medicinal products and devices.
- Solve day-to-day quality issues and maintain qualification status of customers, suppliers, vendors, and clients.
- Develop and refine Standard Operating Procedures (SOPs) and quality agreements.
- Support the preparation and submission of license applications and variations in the UK.
- Manage change controls, deviations, and provide quality advice.
- Oversee packaging and labelling activities from a quality standpoint.
- Evaluate compliance with lawful and ethical standards.
- Suggest improvements that benefit the organization.
- Reach individual objectives set by the Head of Quality.
- 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 (desired).
- Thorough understanding of GMP, GDP, and related regulations.
- Fluency in business English.
- Practical quality approach with a company-wide perspective.
- Proactive team player with innovative ideas.
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