QA Manager GDP

CK Group; London; Hybrid; GBP 100,000 - 125,000; Full time

Job summary

An exciting opportunity for a Quality Manager in operational QA within a global biotechnology company. This hybrid role focuses on ensuring compliance with quality regulations and supports GDP operations globally. Applicants should possess strong knowledge of international GDP regulations and relevant experience in auditing. Join a company dedicated to scientific innovation and develop your career in a collaborative environment.

Qualifications

• Knowledge of GDP, GMP, and GVP regulations is preferred.
• Experience in GDP auditing and compliance.
• Ability to collaborate cross-functionally.

Responsibilities

• Responsible for quality and GDP regulatory compliance.
• Support global processes for distribution of raw materials and products.
• Lead investigations and CAPA.

Skills

Knowledge of International GDP regulations

Previous GDP auditing experience

Ability to learn and develop knowledge

Collaboration

Leading investigations and Root Cause Analysis (RCA)

Tools

Oracle

Veeva

Job description

CK Group are recruiting for a QualityManager, 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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