Manager Quality Services, Third Party Audits

About the job

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference on patients’ daily life, wherever they live and enabling them to enjoy a healthier life. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams in partnership with Business and Digital, and drive priority and transformative initiatives across M&S. The team members of Global M&S Services Hubs will act as partners in carrying out tasks and fulfilling responsibilities to support identified and established global quality processes from the hubs.

Main responsibilities

Provide QA and Technical Support to Third Party Manufacturers (TPM) and Contract Manufacturer Organization (CMO), TPM/CMO Operations, Affiliates, and other StakeholdersResponsible for compliance with Corporate and Divisional QA policies, procedures, standards, and specifications as well as country specific regulations depending on the TPM location and marketsEnsure compliance to Corporate and Divisional QA requirements and identify and / or resolve Quality gaps and / or issues relating to product design, manufacturing quality programs and product start-ups at TPMsResponsible for overall quality and safety of products manufactured at those facilitiesUtilize understanding of QA systems and problem-solving tools to provide alternative solutions to quality issuesManage supplier audits, ensuring cGMP and SOP alignmentTrack market developments, regulatory changesFollow up on CAPAsParticipate in audits, inspections, interface with specialistsProvide an assessment of supplier’s quality in place with regards to material compliance, as well as regulatory of CAPA before communicating it to be the request sitesBeing a local quality contact between the Suppliers, Global Quality Suppliers & IA sites to facilitate follow up of improvements and exchange of quality informationSupport audits lead by other auditors when specific expertise is needed (e.g. for cause audit with user sites representatives, highly sophisticated topic)Conduct on-site and remote audits of GxP and Health Regulated Third Party vendors to ensure compliance with regulations and company policiesCollaborate with stakeholders regionally for inspection preparedness

About you

Experience:

4+ years of Compliance or Auditing experience7-10 years of related experience in the pharmaceutical industryThorough knowledge of cGMPs, Code of Federal Regulations in drugs and biologicsShould be knowledgeable in Quality functions of pharmaceutical industryExperience in conducting on site audits, inspections and facing regulatory/health authority inspections/auditsThorough knowledge of CAPA systems is required and experience is desirableThorough knowledge of and experience in application of GMP requirementsExperience managing third party manufacturers and/or contract manufacturer organization is preferredExperience of working on manufacturing sites is an added advantage. Internal Required skillsExcellent problem solving and decision-making skills are critical to this position. The successful candidate must be able to demonstrate their risk-based decision-making abilityProficient in problem-solving, attention to detail, and good organizational skillsWork in a team-oriented, flexible, and proactive mannerAnalytical skills and ability to multitask in a stressful environment

Education:

Master’s or Ph.D. in Life Sciences/Healthcare, or related technical field

Languages:

Excellent knowledge of English language (spoken and written)

Pursue Progress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

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!

#LI-Hybrid #BarcelonaHub #SanofiHubs

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, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!