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Quality Director and QP
4 weeks ago
AssureBio is supporting a pharmaceutical organisation in the search for an accomplished Quality Director & Qualified Person (QP). This is a critical leadership role requiring an individual with extensive Quality Assurance expertise, strategic leadership capabilities, and a commitment to driving culture change and continuous improvement.
As a key member of the leadership team, you will play a pivotal role in embedding a quality-first mindset across the organisation, ensuring GMP compliance, regulatory excellence, and the continuous supply of medicinal products to market. This is a fully on-site position, offering a unique opportunity to shape the company's Quality and Compliance strategy at the highest level.
Key responsibilities include:
- Providing strategic leadership across Quality teams to ensure efficient product evaluation and release.
- Acting as the Named QP on the company's Manufacturer and Importer Authorisations.
- Leading regulatory inspections and internal self-inspections.
- Overseeing and evolving the Pharmaceutical Quality Management System, ensuring alignment with current GMP regulations and industry best practices.
- Driving a culture of continuous improvement and ensuring effective cross-functional collaboration with Regulatory Affairs, Validation, Sales, Logistics, and Manufacturing.
- Developing and mentoring the QA team, fostering a high-performance, improvement-driven culture.
- Leading complex investigations, including manufacturing deviations and out-of-specification/trend testing.
- Auditing contract manufacturers and laboratories to ensure compliance with EU GMP regulations.
What We're Looking For:
- Qualified Person (QP) status – Essential.
- Extensive experience in manufacturing and testing of non-sterile dosage forms.
- Proven leadership in a Quality function, with experience managing a QA team.
- Strong ability to influence and drive culture change within an organisation.
- Experience in leading cross-functional teams is highly desirable.
- Excellent problem-solving skills and the ability to navigate complex regulatory environments.
- Adaptability and a continuous improvement mindset to refine processes and enhance compliance.
