Sr. Manager – Third Party Audit Management, Hyderabad Hub

Job Description

Job title: Sr. Manager xe2x80x93 Third Party Audit Management, Hyderabad HubLocation: Hyderabad, India% of travel expected: Travel required as per business needJob type: Permanent, Full timeAbout the jobSanofi 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 patientsxe2x80x99 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.Our Team: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 Organizations (CMO), 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.Ensure 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 TPMxe2x80x99s and CMOxe2x80x99s.Support Root Cause Analysis (RCA) investigations of quality events as requiredUtilize understanding of QA systems and problem-solving tools to provide alternative solutions to quality issues.Lead the Quality Compliance team ensuring cGMP compliance and inspection readiness.Manage supplier audit programs and follow-up on regulatory audits.Oversee Regulatory Intelligence and contribute to Quality Risk Management (GRT) on-site.Identify and propose process and procedure improvement proposals.Manage supplier audits, ensuring cGMP and SOP alignment.Track market developments, regulatory changes.Contribute to team effectiveness, identify risks, formulate improvements.Manage work processes efficiently, respect laws.Follow up on CAPAxe2x80x99s.Proactively monitor FDA, EMA requirements, share knowledge.Coach and direct the team, conduct evaluation interviews, and assess training needs.Provide an assessment of supplierxe2x80x99s quality in place with regards to material compliance, as well as regulatory of CAPA for Third Party sitesBeing a local quality contact between the Suppliers, Global Quality Suppliers & IA sites to facilitate 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)Organize day to day agenda according to workload defined by the group. Establish monthly reports and indicators for priority decisions.Conduct on-site and remote audits of GxP and Health Regulated Third Party vendors to ensure compliance with regulations and company policies.Prioritize audit planning to meet audit, assessment, and monitoring plans.Collaborate with stakeholders regionally for inspection preparedness.About youExperience:7 years of Compliance or Auditing experience.10-13 years of related experience in the pharmaceutical industry.Thorough knowledge of cGMPs, Code of Federal Regulations in drugs and biologicsShould be knowledgeable in Quality functions of pharmaceutical industry.Experience in conducting on site audits, inspections and facing regulatory/health authority inspections/audits.Thorough knowledge of CAPA systems is required and experience is desirableThorough knowledge of and experience in application of GMP requirementsExperience managing third party manufacturers is preferred.Experience of working on manufacturing sites is an added advantage.Required skills:Excellent problem solving and decision-making skills are critical to this position. The successful candidate must be able to demonstrate their risk-based decision-making ability.Proficient in problem-solving, attention to detail, and good organizational skills.Work in a team-oriented, flexible, and proactive manner.Analytical skills and ability to multitask in a stressful environment.Education:Masterxe2x80x99s or Ph.D. in Life Sciences/Healthcare, or related technical fieldLanguages: Excellent knowledge of English language (spoken and written)Pursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesnxe2x80x99t happen without people xe2x80x93 people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, letxe2x80x99s 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, disability, or gender identity.Watch our and check out our Diversity Equity and Inclusion actions at !Pursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesnxe2x80x99t happen without people xe2x80x93 people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, letxe2x80x99s 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 and check out our Diversity Equity and Inclusion actions at ! Sanofi