Technical Manager (QA Systems & Compliance)

(12 Month Contract)

• Global Leader in Rare Disease Therapies:This organisation is at the forefront of delivering breakthrough therapeutics for serious and life treating rare genetic diseases.
• Ground breaking Impact:Join a team dedicated to advancing life changing treatments, primarily for conditions affecting children and those with few or no treatment options.
• Innovative Technical Operations:Work in a cutting edge environment with a focus on manufacturing excellence, regulatory compliance, and global collaboration.

As the QA Systems & Compliance Technical Manager, you will:

• Serve as the business process manager for applicable quality systems-assess GMP and regulatory compliance risk, develop/implement mitigation with stakeholders, and drive system improvements.
• Analyse system performance through metrics, troubleshoot issues, benchmark leading practices, and ensure global alignment.
• Provide QA review and approval for Supplier Management and Quality System activities impacting GxP operations (deviations, changes, specifications, technical/quality agreements).
• Support and lead quality system and compliance activities, including audit/inspection preparation, participation, follow up, and site quality management review.
• Collaborate cross functionally to share learnings and ensure consistency.

• Bachelor's degree in Pharmaceutical Sciences, Process Engineering, or a related discipline.
• 10-15+ years' experience in GMP regulated pharmaceutical/biotech environments.
• 3-5 years of leadership experience with people management and cross functional influence.
• Extensive experience supporting regulatory inspections and in depth knowledge of EU GDP and regional regulations.
• Excellent communication, influencing, planning, and organising skills; detail oriented and analytical.

• Competitive Salary:Attractive compensation package based on experience.
• Career Development:Opportunity to lead change initiatives and influence compliance on a global scale.
• Dynamic Work Culture:Be part of an innovative, impactful, and collaborative team making a direct difference in patients' lives.