Head of Quality Assurance Operation

<h1>Head of Quality Assurance Operations</h1><p></p><p><span>Location:</span><span> </span>Riells i Viabrea</p><p><span>Job type:</span><span> </span>Permanent</p><p>Grade level: 2</p><p>Full time</p><p></p><h2>About the job</h2><p></p><p><span>Our Team:</span></p><p>We are the Quality Assurance Operations team at Sanofi&#39;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.</p><p></p><p><span>Main responsibilities:</span></p><p><i>Compliance &amp; Safety</i></p><ul><li>Ensure compliance with labor, quality, environmental, and safety regulations</li><li>Apply HSE protocols including PPE usage, risk prevention, and legal certifications</li></ul><p><i>Quality Management</i></p><ul><li>Define and drive Quality objectives in alignment with the Production Control Unit (PCU)</li><li>Contribute to the site&#39;s Quality Plan</li><li>Create, approve, and maintain general quality procedures for the PCU</li><li>Approve manufacturing and packaging guidelines</li><li>Manage deviations and investigations; propose and follow up on corrective and preventive actions (CAPAs)</li><li>Participate in OOS/OOT investigations related to production</li><li>Lead and facilitate RQN meetings when required</li><li>Monitor change controls and follow up on actions arising from complaints</li><li>Participate in projects, validations, and qualifications within the PCU</li><li>Support internal and external inspections and self-inspections</li></ul><p><i>Daily Operations</i></p><ul><li>Participate in daily Visual Management meetings with the PCU</li><li>Coordinate daily work plans according to logistics priorities</li><li>Monitor PCU activity and manage incidents</li></ul><p><i>Product Release</i></p><ul><li>Act as Deputy Technical Director: release batches of medicinal products to market</li><li>Review release documentation (manufacturing and packaging guidelines)</li><li>Verify closure of deviations prior to release</li><li>Record relevant data in LUNA system</li><li>Ensure compliance with GMP, distribution requirements, and applicable regulations</li></ul><p><i>Team Leadership</i></p><ul><li>Lead and develop the team, fostering a culture of growth and accountability</li><li>Ensure team knowledge, training compliance, and adherence to procedures</li><li>Participate in talent management initiatives</li></ul><h2>About you</h2><ul><li><span>Experience:</span><span> </span>Background in Quality Assurance within the pharmaceutical industry, ideally in a production environment, with previous experience in team leadership or supervisory roles</li><li><span>Technical skills:</span><ul><li>Hands-on knowledge of pharmaceutical manufacturing processes</li><li>Familiarity with QMS (Quality Management Systems) and LIMS</li><li>Experience with ERP systems (SAP preferred)</li><li>Knowledge of GMP, ICH guidelines, and quality certifications (ISO 9001) is a plus</li></ul></li><li><span>Soft skills:</span><ul><li>Strong communication and stakeholder management skills</li><li>Analytical thinking and problem-solving mindset</li><li>Ability to make decisions under pressure</li><li>Results-oriented with a continuous improvement approach</li><li>Adaptable and open to change</li></ul></li><li><span>Education:</span><span> </span>Degree in Pharmacy or related life sciences field. A Master&#39;s in Pharmaceutical Quality, Regulatory Affairs, or similar is a plus</li><li><span>Languages:</span><span> </span>Advanced English is required; Spanish is essential for this role</li></ul><h2>Pursue progress, discover extraordinary</h2><p>Better is out there. Better medications, better outcomes, better science. But progress doesn&#39;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&#39;s be those people.</p><p>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.</p><p></p><p><i><b>Nota para los candidatos:</b></i></p><p><i><span>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.</span></i></p><p></p><p><i><span>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.</span></i></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><h1>Pursue <i>progress</i>, discover <i>extraordinary</i></h1><p>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.</p><p></p><p>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.</p><p></p><p>Watch our <a href="https://www.youtube.com/watch?v&#61;SkpDBZ-CJKw&amp;t&#61;67s" target="_blank">ALL IN video</a> and check out our Diversity Equity and Inclusion actions at <a href="https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness" target="_blank">sanofi.com</a>!</p>