Quality Manager
Our client is a leading innovator in life technology, dedicated to harnessing the body’s natural energy, reverse aging and maximize human potential, while holding true to its values of high product standards, leading with service, being socially responsible, and striving to make a difference through unprecedented humanitarian advancements.
Role Summary
The Quality Manager will be responsible for developing, implementing, and maintaining quality management systems to ensure the highest standards of quality and regulatory compliance across our products and processes. This role involves working closely with cross-functional teams, including R&D, manufacturing, and supply chain, to support product development, manage quality control, and ensure compliance with industry standards and regulations.
Responsibilities
1. Management of the Quality Assurance team, including Qualified Persons.
2. Management of all batch disposition and material status control activities.
3. Management of review of Batch Manufacturing Records (BMRs).
4. Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.
5. Management of the Change Control process, ensuring controlled implementation of all GMP related changes.
6. Management of QA oversight of routine manufacturing, testing and relating activities to ensure ongoing cGMP compliance.
7. Ensuring effective participation of the Quality Assurance team in production and other site meetings.
8. Implementation of Key Performance Indicators within the Quality Assurance area to align with company and global quality objectives.
9. Participation in the site Internal Audit programme.
10. Participation in the preparation of, and hosting, external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
11. Participation in the preparation of documentation for regulatory submission and participation in regulatory affairs discussions.
12. Taking a leadership role in promoting a culture of Compliance, Right First Time and Continuous Improvement.
13. Implementing efficiency improvements in Quality Dept on a continuous basis and participating in site projects and initiatives.
14. Communication and liaison with other departments on Quality issues (as required), providing guidance and support to others.
15. Motivation, training, discipline and appraisal of Quality Assurance staff.
16. Acting as a designee to the Site Quality Head as required.
Requirements
1. Minimum of 5 years in a quality management role within a life technology, biotech, medical device, or pharmaceutical company.
2. Demonstrated experience in QMS development, implementation, and maintenance, including working knowledge of ISO 13485 and FDA 21 CFR Part 820 standards.
3. Proven expertise in materials management, including inspection, testing, and verification processes for raw materials and components.
4. Proficiency in quality control and assurance methods, including statistical analysis, sampling techniques, and material testing.
5. Familiarity with supplier quality management and materials inspection processes.
6. Experience with risk management tools (e.g., FMEA) and CAPA processes.
7. Proficiency with ERP/Quality software systems.
8. Knowledge of Lean, Six Sigma, or other continuous improvement methodologies.
Our client is committed to maintaining the highest standards of quality, safety, and compliance in the life sciences industry. If you’re an experienced Quality Manager with a strong background in QMS and materials management, eager to make a meaningful impact in a dynamic, fast-growing environment, we’d love to hear from you!
#J-18808-Ljbffr