We're partnering with a pioneering gene therapy company, making significant strides in human health. They're seeking a highly motivated and experienced QC Validation Manager to lead critical activities across their UK and Ireland sites. This is a pivotal role for someone who thrives on ensuring the highest standards of quality and compliance in a fast-paced, innovative environment.

This is a 12-month fixed-term contract opportunity.

What You'll Be Doing:

As the QC Validation Manager, you'll be at the forefront of ensuring the quality and integrity of novel and established test methods for gene therapy products. Your key responsibilities will include:

• Leading Method Validation: Drive the development, validation, and transfer of analytical test methods for gene therapy products, ensuring compliance with EU and FDA GMP requirements.
• Lifecycle Management SME: Serve as the go-to expert for the lifecycle management of analytical assays, equipment, and materials, including in-process samples and finished products.
• Ensuring Compliance: Generate comprehensive qualification/validation documentation, ensuring all methods are validated and performed in GMP labs with strict adherence to regulatory standards and data integrity.
• Project Management: Oversee the project management of test method implementation, ensuring seamless launches of new products within required timescales.
• Team Leadership: Guide and mentor a team, fostering a culture of excellence and continuous improvement.
• Stakeholder Communication: Maintain clear and consistent communication with key stakeholders, ensuring information flow and document control.
• Training & Development: Lead the development and rollout of training on new technologies and methodologies introduced to the facility.
• Quality System Adherence: Support the maintenance of the Quality Management System, document control, and overall data integrity.

What We're Looking For:

• Experienced Professional: A degree in Human Health or Sciences, with significant experience in a validation role within the pharmaceutical or other regulated industries (e.g., biologics).
• Proven Leader: You've successfully managed a team and can inspire and motivate others to achieve challenging goals.
• Validation Expert: Deep understanding of regulatory requirements for analytics and stability for Advanced Therapy Medicinal Products (ATMPs), with a track record of implementing, qualifying, and validating analytical methods for GMP testing.
• Regulatory Knowledge: Proficient in EU and FDA regulations, GMP/GLC/GCP, Lean Manufacturing, and Six Sigma principles.
• Travel Ready: Willingness to travel between UK and Ireland sites is essential.

What's On Offer:

This is an exceptional opportunity to join a growing company at the forefront of gene therapy. You'll contribute to life-changing products in a collaborative and supportive environment that values professionalism, quality, and continuous improvement.

Ready to Lead in QC Validation?

If you're a highly skilled and motivated QC Validation Manager looking to make a significant impact in the gene therapy space, we encourage you to apply.