Global Quality - Auditor lead North and South America

at  Sanofi US

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.

QUALIFICATIONS, KNOWLEGDE & SKILLS:

• Experience: 10+ years working experience in Quality management and auditing in Pharmaceutical Industry.

TECHNICAL SKILLS:

• Excellent 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 10 years in a GMP/GDP environment.
• 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. Spanish is a strong asset.

THE ROLE:

Auditor lead role is a senior position with deep experience of Pharmaceutical activities (Manufacturing, Distribution, Country Office, Medical…) & Quality standards and a strong experience of auditing toward international quality standards (EU, FDA…) for a broad range of products. For this, the auditor lead should have held operational Quality Manager roles and have a significant experience as Quality auditors in Companies applying international GxP standards.

MAIN RESPONSIBILITIES:

• Manage a team of auditors located in Bogota (Colombia) and coordinate the activity.
• Conduct GxP audits (CHC sites, Development Centres, country offices, CMOs and Suppliers) mainly in North and 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.
• Ensure adherence to audit metrics and internal departmental SOPs for the region.
• Ensure the effectiveness of the implementation of Sanofi/Opella Quality standards and procedures.
• 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 Inspection coordinator, support the preparation and follow-up of Regulatory Inspections for GxP activities in the Americas region as required.
• Ensure the onboarding, training and certification of the Global Quality auditors in the region and globally as needed.
• Provide expertise on GxP requirements to the entities in the Americas region.
• Organize communications / meetings / Training with the Quality network in the Americas region as necessary.