¿Dónde vas a trabajar?
Leading pharmaceutical company in the Valencia region with international operations.
¿Qué harás en tu nuevo puesto?
- Lead the Quality Assurance and Quality Control departments, ensuring the effectiveness of the Quality System and product quality.
- Define and implement the strategic vision for Quality, including policies, procedures, and data integrity strategies.
- Hold ultimate responsibility for batch release and compliance with regulatory standards (cGMP).
- Serve as the primary contact with Health Authorities, regulatory agencies, customers, and the executive board.
- Manage manufacturing authorisations, certifications, and oversee inspections and audits (health authorities and customers).
- Drive strategic decisions such as implementation of operational procedures (e.G., eQMS, Validation Plans, quality agreements).
- Develop and maintain the Quality Management System (QMS), addressing current and future regulatory requirements and potential gaps.
- Participate actively in corporate projects like new facility commissioning and lead quality-related projects.
- Review and approve major changes, critical deviations, and Master Documents within the Quality System.
- Identify training needs for personnel and collaborate on budget planning for the Quality department.
- Support the implementation of regulatory methodologies in QC and ensure analytical methods adequately evaluate product quality.
- Promote and maintain a strong quality culture across the department and organisation.
¿A quién buscamos (H/M/D)?
The selected candidate must meet the following requirements:
- Degree in Pharmacy or Engineering. Master's degree in sciences relevant to the pharmaceutical industry.
- At least ten (10) years of experience in companies authorised for manufacturing, including qualitative analysis of medicines and active substances, testing and verification's to ensure product quality, as well as GMP quality assurance procedures.
- Experience interfacing with auditors and inspectors to explain quality policies and defend/justify quality practices. Experience preparing processes, systems, and personnel for FDA Pre-Approval Inspections (PAI) in organisations undergoing this for the first time.
- At least five (5) years of experience managing teams of at least five people in high-impact, high-pressure, and critical situations.
- Extensive experience and deep knowledge of pharmaceutical GMP quality control, including analytic techniques and processing in accordance with standards for Drug Substances and Drug Products.
- Extensive experience and deep knowledge of pharmaceutical GMP manufacturing processes (Drug Substances and Drug Products) across different technologies (preferred:
small molecules, biologic, cell and gene therapy, mRNA is a plus).
- Extensive experience and deep knowledge of GMP quality requirements for pharmaceutical products (Drug Substances and Drug Products), including audits and inspections.
- Knowledge of pharmaceutical product development.
- Critical thinking, communication, negotiation, decision-making, results orientation, and problem-solving skills.
- Ability to work as part of a team, especially in making operational and quality procedures safe and efficient.
- Languages (spoken and written):
English and Spanish.
¿Cuáles son tus beneficios?
- Permanent contract in a stable and professional environment.
- Competitive salary.
- Social benefits.
- Opportunities for professional development and continuous training.
- Participation in innovative projects within the healthcare sector.
- A work environment based on excellence and collaboration.