Job Summary

Accountable to lead, manage and ensure that all Contract Manufacturing, Testing and Warehousing organizations contracted by or on behalf of Daiichi Sankyo that provide services through the supply of commercial and investigational drug product is constantly assessed to comply with FDA premises and regulation, another applicable GMP guidelines and internal DS policies, procedures or standards. The incumbent is responsible to identify QA risks at CMO's and support the recommended courses of risk treatment and resolution manner in appropriate way and to ensure continuous improvement in the management of CMO risks. Interacts with DS affiliates and Headquarter to support with routine and unusual issues related with Global Products.

Responsibilities

Quality Management System (QMS): Ensures and support that a robust QMS is in place at CMOs with respect to the facility, equipment & lab instruments, engineering, maintenance, computerized systems and validation activities which complies with GMP guidelines such as ICH and PIC/s as well as FDA regulation requirements, industry best practices and will withstand regulatory inspections by regulatory authorities and regular audits. Drug Product Management: Supports technically the operational activities which include API and drug product manufacturing, packaging and labelling operations, QC testing and release, and distribution for biologics and small-molecules products manufactured at CMO’s and ensures the validation requirements for all global markets are also met. Cross-Functional Team Participation: Responsible for working with Quality Leaders in each operating site to influence and affect the necessary operations managed through the leadership teams and will partner closely with other Subject Matters Expert across all the Functional Units (Global ADC Team Members, Pharmaceutical Technology, QA-GMP and QA R&D functional areas, Regulatory Affairs – CMC, Pharmacovigilance, Medical Affairs and Supply Chain) to ensure compliant operations. Process Validation and Product Technical Transfer: Responsible for review and approval of documents associated with validation or qualification activities, risk assessment strategies, technical studies and applicable changes that may require DS support. Ensure respective compliance with applicable DSI and or DS relevant procedures, standards and instructions that affects and directs CMO activities. This position can be supportive also to oversight and QA support for product and process technology for acquired or transferred product into and out of CMO’s organizations. Deviation and Complaint Investigation Program: Provides support to the investigation of deviations and complaints in order to ensure a timely manner activity and a protective solution to avoid any risk to the quality and safety of commercial and investigational drug products supplied through DSI and DS affiliates.

Qualifications