QA Systems & Compliance Technical Manager
(12 Month Contract)
About Your New Employer
- Global Leader in Rare Disease Therapies: This organisation is at the forefront of delivering breakthrough therapeutics for serious and life-threatening 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.
About Your New Job
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.
What Skills You Need
- 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.
What's on Offer
- 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.
What's Next
Apply now by clicking the “Apply Now" button or contact us for more information. Email afitzpatrick@sigmar.ie or call +353 21 4847136 If this role isn't quite right but you are interested in similar opportunities, please reach out to discuss other available positions.