Drive GMP excellence and shape quality systems that support life‑changing rare disease therapies.
Proclinical is seeking a GMP QA Manager to join a growing team in the rare disease and pharmaceutical sector. In this role, you will ensure compliance with GxP regulations, oversee quality assurance for investigational medicinal product (IMP) manufacturing, and contribute to the development of quality systems that align with clinical and manufacturing needs. This position offers an opportunity to collaborate across multiple functions and drive continuous improvement in a dynamic environment.
Responsibilities:
1. Ensure adherence to GxP compliance regulations, including standard operating procedures and approved documentation.
2. Provide end-to-end quality assurance oversight for IMP manufacturing, including batch record review, QC data approval, and clinical trial release certification.
3. Maintain and improve elements of the Quality Management System (QMS), ensuring risk-based and phase-appropriate processes for clinical development.
4. Manage deviations, investigations, root cause analyses, and CAPAs, ensuring timely closure and effective corrective actions.
5. Support cross-GxP alignment by integrating GCP knowledge into manufacturing, clinical operations, and trial supply activities.
6. Collaborate with Clinical QA to ensure traceability, chain-of-custody integrity, and audit readiness throughout the clinical supply lifecycle.
7. Partner with CMC, Clinical Operations, Regulatory Affairs, Supply Chain, and Development teams to embed quality principles into planning and execution.
8. Provide training, coaching, and QA guidance to internal teams and external partners to enhance GxP awareness and compliance.
9. Drive a culture of continuous improvement by identifying process gaps and implementing scalable solutions.
10. Contribute to the strategic development of the Quality function, ensuring phase-appropriate processes and supporting risk assessments and decision-making.
Key Skills and Requirements:
11. Degree in science, life sciences, or a related field.
12. Expertise in GMP oversight of IMP manufacturing, QC, and batch disposition for clinical trials.
13. Knowledge of global GMP regulations, including Eudralex vol. 4, cGMPs, Good Documentation Practices, and Data Integrity (ALCOA).
14. Experience authoring and reviewing GxP documents such as SOPs, forms, templates, and QTAs.
15. Working knowledge of GCP to provide cross-GxP coverage.
16. Proficiency in risk-based QMS processes, including deviation management, root cause analysis, and CAPA implementation.
17. Vendor management experience, including audits, CDMOs, labs, and inspection readiness.
18. Familiarity with equipment validation and environmental monitoring of cold storage areas.
19. Strong analytical and critical thinking skills with pragmatic decision-making abilities.
20. Effective communication skills to engage technical and non-technical stakeholders.
21. Ability to work autonomously and train internal teams and external partners.
22. Resilience and adaptability in a fast-paced, scaling biotech environment.