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Quality Director / QP
Job Posted: 14 days ago
Salary: £ 90,000 - 140,000 / Annum
Job Type: Permanent
Location: Newcastle upon Tyne, Tyne & Wear
Expire in: 14 days
Job Description
Are you looking to work with ATMPs and biotechnology products?
Do you want to operate at the cutting edge of Life Sciences?
Are you ready to shape the future by leading a high-performing quality team?
A pioneering biotech organisation in the North East is seeking a Director of Quality (QP) to join its growing team. This is a unique opportunity to play a pivotal role in the development and release of novel advanced therapy medicinal products (ATMPs) and biologics that are changing the future of healthcare.
With a focus on patient impact, this company’s pipeline is packed with breakthrough therapies in clinical and pre-commercial phases. You will be joining at a critical time, with real opportunity to put your stamp on quality strategy, systems, and culture.
Key Responsibilities:
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Act as the Qualified Person (QP) for the certification and release of ATMPs and biologic products
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Provide strategic leadership across GMP compliance, QA systems, and continuous improvement
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Build and develop a high-performing QA team, fostering a strong quality culture across operations
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Oversee all aspects of GxP inspections, audits, and regulatory submissions
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Partner cross-functionally with Manufacturing, Regulatory, and R&D to ensure quality is embedded at every stage
About You:
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Eligible to act as a Qualified Person under UK regulations (Directive 2001/83/EC)
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Proven leadership experience in GMP quality roles, ideally within ATMPs, biologics, or cell/gene therapy
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Strong knowledge of MHRA, EMA, and FDA regulatory expectations
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Comfortable working in a fast-paced, evolving environment where innovation is the norm
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Passionate about mentoring others and scaling up quality teams and systems
Why Apply?
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Join a mission-driven company focused on life-saving innovation
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Work with cutting-edge biologics and advanced therapies
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Influence company direction and build your own team from the ground up
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Attractive package and long-term career progression in a high-growth environmentBefore You Apply
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