We are recruiting a QA Validation & Projects Manager to provide quality and validation leadership across Alliance Medical Radiopharmacy’s UK operations. Reporting directly to the Head of Quality UK, this role sits at a senior level within the Quality function and has accountability for validation activities across all UK Radiopharmacy sites.
You will act as a key interface between Quality Assurance, Regulatory Affairs, Operations and Quality Control, ensuring consistent standards, robust quality systems and ongoing inspection readiness across the network. The role combines strategic oversight with hands‑on delivery, supporting both routine commercial operations and development and project programmes in a highly regulated GMP environment.
As QA Validation & Projects Manager, you will play a central role in maintaining regulatory compliance and driving continual improvement across a multi‑site operation. You will provide expert oversight, leadership and practical support to ensure validation and quality activities are robust, harmonised and inspection‑ready at all times.
Key responsibilities
- Providing QA and validation leadership across all UK Radiopharmacy facilities
- Acting as the QA Validation lead for both commercial and IMP activities
- Overseeing and harmonising validation activities across multiple sites, including deviations, change control, CAPAs, documentation and risk management
- Acting as a subject matter expert for validation and advising site teams on projects and continuous improvement initiatives
- Supporting MHRA and regulatory authority inspections, audits and responses, ensuring ongoing compliance commitments are met
- Reviewing and approving quality and regulatory documentation, including SOPs, batch documentation and validation protocols
- Providing QA input into product development, technology transfer and validation activities within sterile and radiopharmacy environments
- Supporting the implementation of new electronic Document and Quality Management Systems
- Contributing to Global Quality Management meetings and tracking actions to completion
- Coaching and mentoring QA project teams and site stakeholders, acting as a role model for quality and compliance
- Supporting the Head of Quality in embedding a strong quality culture, continuous improvement and inspection readiness across the UK network
This role is suited to an experienced QA validation professional who is comfortable operating across multiple sites and engaging with both operational teams and senior stakeholders. You will bring strong regulatory knowledge, leadership capability and the confidence to take ownership in a complex, fast‑paced environment.
Qualifications and Experience
- A degree (or equivalent experience) in validation, quality or a related pharmaceutical discipline
- A strong background in validation, ideally with 5+ years’ experience in a pharmaceutical, radiopharmacy, sterile manufacturing or aseptic processing environment
- Proven QA and validation experience within GMP‑regulated manufacturing
- Demonstrable experience supporting commercial products and IMP development
- Strong working knowledge of UK and EU GMP, MHRA requirements and wider GxP compliance
- Experience working across multi‑site operations and implementing consistent quality standards
- Experience supporting regulatory inspections, audits and authority interactions
- Previous managerial or supervisory experience, with a track record of motivating and influencing teams
- Excellent written and verbal communication skills with the ability to engage at all levels
- Strong organisational skills, attention to detail and the ability to work proactively and independently
- A collaborative, adaptable approach with the confidence to lead by example in quality and compliance
#J-18808-Ljbffr…