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We are the Quality Assurance Operations team in Riells i Viabrea, dedicated to ensuring that every product we release meets the highest quality and safety standards. Our team plays a critical role in bridging production and quality, working closely with manufacturing units to guarantee compliance with Good Manufacturing Practices (GMP) and Sanofi Group regulations. We are a team driven by rigor, collaboration, and a shared commitment to patient safety.

Main responsibilities:

Compliance & Safety

- Ensure compliance with labor, quality, environmental, and safety regulations
- Apply HSE protocols including PPE usage, risk prevention, and legal certifications

Quality Management

- Define and drive Quality objectives in alignment with the Production Control Unit (PCU)
- Contribute to the site's Quality Plan
- Create, approve, and maintain general quality procedures for the PCU
- Approve manufacturing and packaging guidelines
- Manage deviations and investigations; propose and follow up on corrective and preventive actions (CAPAs)
- Participate in OOS/OOT investigations related to production
- Lead and facilitate RQN meetings when required
- Monitor change controls and follow up on actions arising from complaints
- Participate in projects, validations, and qualifications within the PCU
- Support internal and external inspections and self-inspections

Daily Operations

- Participate in daily Visual Management meetings with the PCU
- Coordinate daily work plans according to logistics priorities
- Monitor PCU activity and manage incidents

Product Release

- Act as Deputy Technical Director: release medicinal product batches to the market
- Review release documentation (manufacturing and packaging records)
- Verify closure of deviations prior to release
- Record relevant data in the LUNA system
- Ensure compliance with GMP, distribution requirements, and applicable regulations





Team Leadership

- Lead and develop the team, fostering a culture of growth and accountability
- Ensure team knowledge, training compliance, and adherence to procedures
- Participate in talent management initiatives

About you

- Proven track record in Quality Assurance within the pharmaceutical industry, ideally in a manufacturing environment, with previous experience in team leadership or supervisory roles
- Degree in Pharmacy or a related life sciences field. A Master’s degree in Pharmaceutical Quality, Regulatory Affairs, or similar is a plus
- Practical knowledge of pharmaceutical manufacturing processes
- Familiarity with QMS (Quality Management Systems) and LIMS
- Experience with ERP systems (SAP is an advantage)
- Knowledge of GMP, ICH guidelines, and quality certifications (ISO 9001) is considered a plus

Interpersonal skills:

- Strong communication and stakeholder management skills
- Analytical thinking and a problem-solving mindset
- Ability to make decisions under pressure
- Results-oriented with a focus on continuous improvement
- Adaptable and open to change

Languages:

- Advanced English is required; Spanish is essential for this role

Note for candidates:

The Riells site, currently owned by Sanofi, is part of this transactional agreement and is expected to be transferred to Adamed. Candidates hired during this period will initially be employed by Sanofi under an employment contract and will later be transferred to Adamed once the transaction is completed.

By applying for this position, your personal data will be processed solely for the purpose of evaluating your application. Your personal data will be jointly managed by both participating companies, Adamed and Sanofi, both of which will handle your information securely and in full compliance with GDPR, and it will be retained only for the time necessary to complete the recruitment process.

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📌 Quality Assurance Operations Manager and QP - riells i viabrea (Riells y Viabrea)
🏢 Adamed Pharma
📍 Riells y Viabrea