Senior Manager

Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated ‘pure play’ biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives. Key Responsibilities Responsible for managing SAP Master data Governance. Expert in handling and guiding customer, vendor and material data management in SAP MDG. Ensure QA oversight for the entire lifecycle management of SAP with continuous tracking and monitoring. To provide update to leadership & management with KPI’s & Metrics of master data governance. Need to manage a team handling the master data governance activities and provide training over the technical and quality aspects. Expertise in handling QMS activities like change controls , Deviations and support as lead investigator and approver. Able to handle audits & inspections from HA’s over SAP MDG. Needed strong stakeholder management skills to manage multiple cross functional teams like commercial , procurement , supply chain , IT…etc. Professional Qualifications 15+ years in IT Industry with SAP Expertise and ability to drive , design and ensure SAP systems. Able to handle IT Infrastructure & Network Qualifications Experience in Pharmaceutical organization Expertise in Testing, Computer Systems Validation and GxP Compliance. Expertise in implementing 21 CFR Part 11, EU Annex 11, GAMP5 guidance. Experience managing internal/external audits and inspections. Strong verbal communications skills. Experience in QMS management, Quality metrics and reporting. Experience managing stakeholder expectations. Ability to deal with uncertainties and navigating through ambiguities. Experience in handling team and cross functional teams Educational Background: Post graduate in Engineering or Science or Other platforms with SAP expertise and certifications. Job Description Responsible for ensuring the compliance of all Master data Governance in SAP. Accountable for timely delivery of validation activities for SAP as a QA. Accountable for accuracy of master data governance in SAP as a Data Steward. To ensure Zero critical points in any of the audits with respect to processes in SAP Data governance systems. To coordinate with the Information Technology department and other stakeholders related to existing data governance program for its timely completion. Provide training to team members on core application functionality. Approve QMS activities like change controls and Deviations. Review and support delivery of Project Deliverables as per the Project Plan. Author and Review applicable SOPs /governing processes. Review and support any other site related Documentation, as required. Values & Behaviors Agile, Proactive and Quality mindset Result and Solution oriented Collaborative and Innovative Maintaining integrity Team player Biocon Biologics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, colour, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Biocon Biologics also complies with all applicable national, state and local laws governing non-discrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act.