**Primary Job Function: TPM’s supplying to Biosimilars in India and APAC region** + Quality Oversight of TPM’s + QMS Management at TPM’s + Inspection readiness for Abbott audits and Regulatory audits for sites under responsibility + Investigations of Products failures, OOS, Complaints pertaining to Abbott products + Review of APQR’s + GMP compliance at TPMs. + Compliance to Abbott procedures and policies. **Core Job Responsibilities:** + Responsible and accountable for the oversight of quality operations and GMP compliance across the TPM’s under responsibility of EPD Biosimilars Operations in India. + Effectively monitoring the rating of responsible TPM sites. + Leading the implementation of quality strategy and plan at the TPM sites including implementation of Abbott policies. + Implement quality Projects at identified TPM’s from time to time + Ensure Quality and compliance to regulatory wrt labelling, stability studies and documentation to deliver acceptable quality products coming TPM sites to consumers on sustainable basis. + Develop strategy on quality as per Abbott’s EPD requirements for the supply chain organization in the third party sites in applicable region. + Promote QMS as important management tool with increased visibility across the business and guide the team for effective implementation at 3rd party contractors. + Create culture which imbibes quality as a way of working through identified trainings and awareness programs for assigned TPM sites. + Establish and implement a process to ensure all customer complaints/queries are addressed as per Abbott policy in stipulated time at applicable TPM sites. + Periodic quality reviews with responsible TPM QA team. **Supervisory/Management Responsibilities:** Direct Reports: 00 Indirect Reports: 00 **Position Accountability/Scope:** + To identify training needs and support the TPM for Biosimilars portfolio + Monitor and ensure complaints are closed within timelines with adequate investigations. + Complete QA review and approval for FLQR on time , change control, exception documents for QA standpoint + Ensure supply and commitment to regulatory filings in Abbott markets. + Ensure change controls are assessed in a complaint manner and the products are supplied to respective markets only when changes are approved. **Minimum Education:** + M Pharm, M.Sc Biochemistry, Microbiology or equivalent **Minimum Experience/Training Required:** + Total experience (in years): Minimum 12 years + Experience in Quality function of a Biosimilar site is a positive An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com