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Qualified person

Chelmsford
BioTalent
Posted: 13 April
Offer description

BioTalent have partnered with a global life sciences and healthcare organisation that plays a critical role in supporting the development, storage, and distribution of products that help improve lives around the world.

This business operates at the intersection of science, quality, and patient impact, providing specialist services that support pharmaceutical, biotech, and clinical supply operations. Their work contributes to important areas such as clinical development, product integrity, regulatory compliance, and supply chain excellence.

They are now looking to appoint an experienced Qualified Person (QP) to join the UK team on a 2-year fixed-term contract, working part-time (22.5 hours per week) in a hybrid arrangement across Monday to Wednesday.

The Opportunity

This is a key quality leadership role, supporting regulated operations within a specialist life sciences environment. The successful candidate will provide QP certification and declarations, contribute technical expertise across operations, and support audit and compliance activities.

This is an excellent opportunity for a QP who enjoys working in a high-quality, collaborative, and purpose-driven environment, with the flexibility of a structured Mon–Wed hybrid setup.

Key Responsibilities

* Provide QP certification in line with regulatory requirements and client technical agreements
* Perform QP GMP declarations, including on-site audits where required to support importation activities
* Deliver UK QP oversight activities
* Conduct internal and external audits as needed
* Provide and support GMP training across the business
* Offer guidance to internal teams on QP roles and responsibilities
* Support Business Development, Sales, and Project Management during pre-contract assessments for new opportunities
* Maintain awareness of relevant regulatory developments and advise colleagues where appropriate
* Support the preparation and review of Technical Agreements
* Contribute QP expertise during client and regulatory inspections/audits
* Undertake travel and off-site work where required

To be considered, you'll need to meet the UK requirements for Qualified Person status and bring strong experience in a regulated pharmaceutical or clinical supply setting.

Ideal Background

* Eligible and operating as a Qualified Person (QP) in the UK
* Proven experience acting as a QP for IMPs
* Experience with biological products would be highly advantageous
* Strong understanding of GMP, regulatory expectations, and quality oversight
* Comfortable working cross-functionally with operational, commercial, and quality teams
* Prior exposure to pharmaceutical development processes would be beneficial

Reach out for more information: luisa.namadila@biotalent.com

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