BioTalent are happy to be supporting a ATMP organisation looking to recruit a QA Ops Specialist. In this role, you will play a critical part in ensuring GMP compliance in manufacturing operations, supporting the production of life-changing cell and gene therapies.

Key Responsibilities:

• Provide quality oversight of GMP manufacturing activities to ensure compliance with regulatory requirements.
• Support batch review and release processes, including documentation review and deviation assessments.
• Participate in investigations of deviations, CAPAs, and change controls, ensuring timely resolution and continuous improvement.
• Conduct GMP audits and inspections of manufacturing areas, ensuring adherence to SOPs and quality standards.
• Review and approve manufacturing and laboratory records, including equipment qualification and validation protocols.
• Act as a key QA liaison between production, QC, and regulatory teams to maintain high-quality standards.
• Support regulatory submissions and inspections (MHRA, FDA, EMA), ensuring readiness and compliance.
• Provide training and mentoring to manufacturing teams on quality and compliance best practices.

Requirements:

• Experience in GMP quality assurance within a pharmaceutical or biotechnology environment, preferably in ATMP, cell therapy, gene therapy, or biologics.
• Strong understanding of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and relevant regulatory guidelines (MHRA, EMA, FDA, ICH, Eudralex).
• Experience with quality systems such as deviations, CAPAs, change control, and batch record review.
• Excellent attention to detail, problem-solving skills, and ability to work in a fast-paced environment.
• Strong communication and collaboration skills, with experience working cross-functionally.

What’s in it for you?

• Be part of a cutting-edge biopharmaceutical company making a real impact on patients' lives.
• Work in an innovative and fast-growing ATMP environment.
• Competitive salary and benefits package, including career growth opportunities.
• A supportive and collaborative team culture.