Manager Quality Services, Third Party Audits

About The JobWe are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?Join our Global Manufacturing and Supply Services Team as Senior Manager Quality Services and you can help make it happen. Our mission is to deliver and support Global M&S teams in partnership with Business and Digital, and drive priority and transformative initiatives across the organisation. Your job? You will be responsible for acting as partners to M&S organization in carrying out tasks and fulfilling responsibilities to support identified and established global quality processes from the hubs. (Travel is required as per business need).Main ResponsibilitiesLeads and defines the priorities and deliverables of Hubs, fostering a culture of quality and collaboration.Provide Technical Support to Third Party Manufacturers and Contract Manufacturer Organizations, TPM/CMO Operations, Affiliates, and other Stakeholders.Responsible for compliance with Corporate and Divisional QA policies, procedures, standards, and specifications as well as country specific regulations depending on the TPM/CMO location and markets. Manage supplier audit programs and follow-up on regulatory audits.Provide an assessment of supplier’s quality in place with regards to material compliance, as well as regulatory of CAPA for Third Party sites.Support audits lead by other auditors when specific expertise is needed.Collaborate with stakeholders regionally for inspection preparedness.About YouExperience: 4+ years in Compliance or Auditing, 7 – 10 years in the pharmaceutical industry, conducting on-site audits, inspections and facing regulatory/health authority inspections/audits, application of GMP requirementsTechnical skills: Knowledge of cGMPs, Code of Federal Regulations in drugs and biologics, knowledge of CAPA systems is required and experience is desirable, knowledgeable in Quality functions of pharmaceutical industry.Soft skills: Excellent problem solving and decision-making skills, risk-based decision-making ability, proficient in problem-solving, attention to detail, proactive, and good organizational skills. Education: Master’s or Ph.D. in Life Sciences/Healthcare, or related technical field.Languages: Excellent knowledge of English language (spoken and written).null