Global Quality Lead
hace 1 mes
We are seeking a highly experienced and skilled Auditor Lead to join our team at Sanofi Consumer Healthcare. As a key member of our CHC Audits and Inspections team, you will be responsible for defining and implementing our CHC Global Quality Audit policy across the business.
Your mission will be 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.
Key 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.
We are looking for a highly experienced and skilled individual with a strong background in Quality management and auditing in the Pharmaceutical Industry. You should have:
- 10+ years working experience in Quality management and auditing in Pharmaceutical Industry.
- 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.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. We are committed to creating a diverse and inclusive workplace where everyone can thrive.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com
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