Opella, the Consumer Healthcare business unit of Sanofi, is the purest and third-largest player globally in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market.
We have an unshakable belief in the power of self-care and the role it can play in creating a healthier society and a healthier planet.
That's why we want to make self-care as simple as it should be by being consumer-led always, with science at our core.
Through our unique and balanced portfolio of more than 100 loved brands, including 15 global and local high-growth challengers such as Allegra, Dulcolax and Buscopan, we deliver our mission: helping more than half a billion consumers worldwide take their health in their hands.
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This mission is brought to life by an 11,000-strong team, 13 best-in-class manufacturing sites, and 4 specialized science and innovation development centers.
We are also proud to be the first major fast-moving consumer healthcare company to achieve B Corp certification.
Join us on our mission. Health. In your hands.
About the job
The mission of our team is to define the CHC Global Quality Audit policy and to coordinate its implementation across the business and to provide an accurate, independent assessment of CHC sites, Development Centres, country offices, CDMOs and Suppliers for compliance with Sanofi / Opella Quality Policy / requirements and applicable regulations through audit and inspection support activities.
Main responsibilities:
- Conduct GxP audits (CHC sites, Development Centres, country offices, CDMOs and Suppliers of Active pharmaceutical ingredients, raw Materials, packaging components) mainly in North & South Americas (significant part of the time dedicated to international travels)
- Support the worldwide auditor's team as necessary.
- Prepare audits and issue audit reports in a timely manner.
- Conduct Global transversal assessment audits.
- Approve / Manage audit CAPA to agreed timelines.
- Keep up to date with current and forthcoming regulatory authority requirements, and relevant Sanofi/Opella Global Quality documents.
- Effectively evaluates compliance with these requirements at Opella entities and third parties and identifies ways for these entities to increase their level of compliance.
- Together with the Audit lead & Inspection coordinator, support the preparation and follow-up of Regulatory Inspections for GxP activities in the Americas region as required.
- Support the training and certification of the Global Quality auditors in the region.
- Provide expertise on GxP requirements to the entities in the Americas region. Support the local auditors when specific expertise is necessary.
- Organize communications and Training for the Quality network in the Americas region as necessary.
About you
Experience: 10+ years working experience in Quality management and auditing in Pharmaceutical Industry.
International experience being audited and conducting audits in the pharmaceutical human consumption industry
Technical skills:
- Good knowledge of GXP regulations and pharmaceuticals standards for a wide range of products (CHC Drug Products, Nutraceuticals, Cosmetics, Medical Devices)
- Be a qualified auditor, minimum experience of 5 years in a GMP/GDP environment.
- Ability to make accurate quality evaluations based on multiple data coming from different sources
Organization and communication skills, networking capability, leadership and assertiveness skills.
Education: Pharmacist or advanced degree (e.g., Master, PhD or equivalent) in life sciences or related fields
Languages: English spoken and written compulsory. Speaking Spanish is an asset.
Why choose us?
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
- Play an instrumental part in creating best practice within our manufacturing facility.
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.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!