TechnicalComplianceLead(GxPManufacturing)

## **Career Category** Information Systems ## ## **Job Description** ** _ABOUT AMGEN_** Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. **_ABOUT THE ROLE_** ** _Role Description:_** The role is part of the Manufacturing Site Technology Sustainment team, responsible for the end to end Compliance & Validation activities. This role will be responsible to provide oversight and adherence of all periodic & data integrity tasks. This individual will assist with investigations and leverages domain and business process expertise to detail technical findings, along with supporting artifacts. This role involves working closely with business analysts, quality and system owners to ensure that systems are maintained and kept in validated state of operations. You will collaborate with site compliance leads to maintain an efficient and consistent process, ensuring quality deliverables from the team. **_Roles & Responsibilities:_** * Accountable for team of Compliance Analyst in support of Compliance activities at the manufacturing sites * Responsible for the computer validation / compliance (computer validation, validation lifecycle processes, DTI data integrity, inspection readiness) * Responsible for the schedule adherence of the GxP periodic review & Data Integrity activities * Collaborate with Site Compliance or Validation Lead to review and mitigate exceptions, ensuring conformance to regulatory requirements * Collaborate with Global Quality, Compliance Teams and System owners to ensure alignment with Amgen standards and requirements * Provide support to assist in investigation of deviations, data