Head of Quality Assurance Operation

Head of Quality Assurance Operations

Location: Riells i Viabrea

Job type: Permanent

Grade level: 2

Full time

About the job

Our Team:

We are the Quality Assurance Operations team at Sanofi's site 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 batches of medicinal products to market
• Review release documentation (manufacturing and packaging guidelines)
• Verify closure of deviations prior to release
• Record relevant data in 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

• Experience: Background in Quality Assurance within the pharmaceutical industry, ideally in a production environment, with previous experience in team leadership or supervisory roles
• Technical skills:
  • Hands-on knowledge of pharmaceutical manufacturing processes
  • Familiarity with QMS (Quality Management Systems) and LIMS
  • Experience with ERP systems (SAP preferred)
  • Knowledge of GMP, ICH guidelines, and quality certifications (ISO 9001) is a plus
• Soft skills:
  • Strong communication and stakeholder management skills
  • Analytical thinking and problem-solving mindset
  • Ability to make decisions under pressure
  • Results-oriented with a continuous improvement approach
  • Adaptable and open to change
• Education: Degree in Pharmacy or related life sciences field. A Master's in Pharmaceutical Quality, Regulatory Affairs, or similar is a plus
• Languages: Advanced English is required; Spanish is essential for this role

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Nota para los candidatos:

El centro de Riells, actualmente propiedad de Sanofi, forma parte de este acuerdo transaccional y está previsto que sea transferido a Adamed. Los candidatos contratados durante este período se incorporarán inicialmente con un contrato laboral de Sanofi y posteriormente serán transferidos a Adamed una vez se complete la transacción.

Al solicitar este puesto, sus datos personales serán procesados únicamente con el propósito de evaluar su candidatura. Sus datos personales serán gestionados conjuntamente por las dos empresas participantes, Adamed y Sanofi, ambas manejarán su información de forma segura y en pleno cumplimiento con el RGPD, y se conservarán únicamente durante el tiempo necesario para completar el proceso de selección.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!