Leading pharmaceutical company in the Valencia region with international operations
We are seeking a Quality Assurance and Quality Control Director to lead our QA/QC departments. The role involves:
- Ensuring the effectiveness of the Quality System and product quality.
- Defining and implementing strategic vision for Quality, including policies, procedures, and data integrity strategies.
- Holding ultimate responsibility for batch release and compliance with regulatory standards (cGMP).
- Serving as the primary contact with Health Authorities, regulatory agencies, customers, and the executive board.
- Managing manufacturing authorisations, certifications, and overseeing inspections and audits.
- Driving strategic decisions such as operational procedures (e.g., eQMS, Validation Plans, quality agreements).
- Developing and maintaining the Quality Management System (QMS), addressing regulatory requirements and gaps.
- Participating in corporate projects like new facility commissioning and leading quality-related projects.
- Reviewing and approving major changes, critical deviations, and Master Documents within the Quality System.
- Identifying training needs and collaborating on budget planning for the department.
- Supporting regulatory methodologies in QC and analytical methods evaluation.
- Promoting a strong quality culture across the organization.
What we offer
- Permanent contract in a stable and professional environment.
- Competitive salary and social benefits.
- Opportunities for professional development and continuous training.
- Participation in innovative healthcare projects.
- A collaborative and excellence-driven work environment.