• Location: Bogota, Colombia

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 Centers, country offices, CDMOs and Suppliers for compliance with Sanofi / Opella Quality Policy / requirements and applicable regulations through audit and inspection support activities

At Sanofi Consumer Healthcare, we have one overarching mission - to work passionately, challenging ourselves and our industry every day, to build a healthier future by helping people, help themselves, bringing “Health in Your Hands”.

Our teams are building trusted & loved brands that connect with hundreds of millions of consumers worldwide, enabling better self-care for individuals and communities, while also contributing to a healthier planet. To fulfill this mission, we are embarking our consumers, our customers, healthcare professionals, and our employees in this journey because this is what will make us become the “Best Fast-Moving Consumer Healthcare (FMCH) Company In & For the World”.

We strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view.

To achieve this, we need strong talent who will help us shape the future of our Consumer Healthcare business and challenge our industry. At Sanofi Consumer Healthcare, we aspire to create a work environment where people can thrive, grow, and be at their best every day. Our priority is working with integrity to improve the health and well-being of people and communities where we operate, working towards making a positive impact in the world.

Main responsibilities:

  • Conduct GxP audits (CHC sites, Development Centers, 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.

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

Soft skills:

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.

  • Our Waterford site is easily accessible from the M9 and offers excellent facilities including a subsidized restaurant and newly refurbished gym.

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.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !