Quality Director and Qualified Person (QP)

AssureBio is supporting a pharmaceutical organisation in the search for an accomplished Quality Director and 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.