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.
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