QA Manager GDP
Posted Today by CK Group- Science, Clinical and Technical
£450 Per day
Inside
Hybrid
Paddington
Summary: The Quality Manager for operational QA (GDP) will oversee quality and regulatory compliance within a global biotechnology company for a 12-month contract. This role involves developing global processes for the distribution of raw materials and medicinal products while supporting GDP operations across the company's distribution network. The position requires collaboration with various stakeholders and a strong background in GDP and GMP regulations. The role is hybrid, requiring three days a week at the client's site in London, Paddington.
Key Responsibilities:
- Oversee principles and application of quality and GDP regulatory compliance.
- Support development of global processes for distribution of raw materials and medicinal products.
- Manage GDP operations for all distribution activities globally.
- Collaborate with key stakeholders including Operations QA, International Supply Chain, and Vendor Management.
- Lead event investigations, Root Cause Analysis (RCA), and CAPA.
- Ensure compliance with International GDP regulations and support auditing processes.
Key Skills:
- Knowledge of International GDP regulations; GMP and GVP regulations preferred.
- Previous GDP auditing experience; GMP experience is preferable.
- Ability to learn and disseminate new information effectively.
- Strong collaboration skills to work cross-functionally.
- Experience with applications such as Oracle and Veeva.
Salary (Rate): £450/day
City: Paddington
Country: UK
Working Arrangements: hybrid
IR35 Status: inside IR35
Seniority Level: undetermined
Industry: Other
CK Group are recruiting for a Quality Manager, in operational QA (GDP), to join a global biotechnology company, on a contract basis for 12 months.
Salary: £370 - £450 per day PAYE. This role is inside IR35.
Quality Manager, GDP Operational QA Role:
The Quality Manager is responsible for the principles and application of quality and GDP regulatory compliance.
The Quality Manager will support the development of global processes for distribution of the client’s raw materials, intermediates, and medicinal products (commercial and clinical) across its global distribution network.
This role supports GDP operations for all distribution activities globally; key stakeholders include Operations QA, International Supply chain, demand planning, logistics, Geographic expansion, QMS/OMS QA, Vendor Management & AIM QA.
Responsible in the Quality Processes/Process Ownership for the distribution of Commercial & Clinical Finished Goods raw materials and intermediates.
Your Background:
Knowledge of International GDP regulations; GMP and GVP regulations as a preference.
Previous GDP auditing experience, GMP experience preferable.
Ability to learn new information and roll out to the wider audience to develop their knowledge.
Work cross functionally to foster exceptional collaboration.
Leading event investigations, Root Cause Analysis (RCA), and CAPA.
Applications such as Oracle and Veeva.
Company: Our client is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases.
Location: This role is hybrid 3 days per week, based at our client's site in London, Paddington.
Apply: It is essential that applicants hold entitlement to work in the UK. Please quote job reference 138 523 in all correspondence. Please note: This role could be subject to a basic Disclosures and Barring Service (DBS) check.
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