As QC Validation Manager, you will be responsible for the validation and transfer of analytical methods, ensuring compliance with EU and FDA GMP standards. You’ll oversee lifecycle management of assays, equipment, and materials, as well as supporting product launches through effective project management. Acting as a subject matter expert, you’ll also play a key role in training, mentoring, and driving continuous improvement across QC operations.
Key Responsibilities:
- Lead the validation and implementation of analytical test methods for new and existing products.
- Provide SME support for assay lifecycle management, equipment, and materials.
- Manage qualification/validation projects and associated documentation in line with GMP and data integrity requirements.
- Oversee method transfer and ensure timelines for new product launches are met.
- Ensure external testing activities meet GMP standards.
- Deliver training on new technologies/methodologies to QC teams.
- Support Quality Management System activities, document control, and compliance.
- Lead and mentor a small team of Validation specialists to ensure training, compliance, and performance standards are achieved.
What We’re Looking For:
- Degree in Life Sciences, Human Health, or equivalent relevant experience.
- Significant validation experience within the pharmaceutical or other regulated industry (e.g., biologics).
- Previous experience managing a team.
- Strong knowledge of EU and FDA regulations, GMP/GLP/GCP, and quality systems.
- Track record of delivering projects on time and to a high standard.
- Strong leadership, problem-solving, and organisational skills.
- Proficiency with Microsoft Office applications.
The Ideal Candidate:
You’ll be independent, motivated, and detail-oriented, with the ability to manage multiple projects simultaneously. This role suits someone who thrives in a fast-paced environment, can lead from the front, and is passionate about quality and compliance.
If you’re an experienced validation professional ready to take the next step in your career, we’d love to hear from you. Apply today to discuss this opportunity in more detail.
