Join a dynamic team at a leading Contract Manufacturing Organisation and contribute to groundbreaking projects and cutting-edge solutions.
Proclinical is seeking a QA Project Manager to provide both tactical and strategic leadership for a team of QA Project Managers. In this role, you will ensure quality deliverables are met for internal and external customers, oversee compliance with regulatory standards, and drive continuous improvement initiatives. This position requires a proactive approach to managing quality assurance processes, mentoring team members, and resolving quality-related issues effectively.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
1. Provide leadership, guidance, and support to QA Project Managers to ensure quality deliverables are met.
2. Oversee sterility assurance assessments, process validation, and material assessments during tech transfers.
3. Address and resolve issues related to tech transfer, deviations, change controls, and regulatory compliance.
4. Manage and track key performance indicators (KPIs) for internal and external customers.
5. Train and mentor the QA team, fostering professional development and ensuring alignment with quality principles.
6. Act as a point of escalation for QA staff and customers, providing solutions to quality-related challenges.
7. Develop team goals, drive continuous improvement, and monitor progress.
8. Conduct objective-setting sessions and provide regular feedback to team members.
9. Serve as QA Project Manager for client projects when required.
10. Partner with internal teams to review and support change controls, deviations, CAPAs, and investigations.
11. Represent the department in site meetings and provide input on quality requirements.
12. Prepare deviation trending reports, assess trends, and recommend improvements.
13. Support regulatory and customer audits as needed.
Key Skills and Requirements:
14. Strong background in Quality Assurance within the biotechnology or pharmaceutical industry.
15. Proven ability to manage and mentor direct reports, fostering a collaborative and efficient team environment.
16. Expertise in handling sterility assurance, process validation, and regulatory compliance.
17. Skilled in managing change controls, deviations, CAPAs, and root cause analysis.
18. Proficient in tracking and analyzing KPIs to drive quality improvements.
19. Excellent communication and leadership skills, with the ability to act as a point of escalation.
20. Experience supporting regulatory and customer audits.
21. Educational background in Science, Biotechnology, or a related discipline (BSc/MSc preferred).