Senior Specialist, APAC Inspection Management (Contractor)
- Beijing
- Contract
- Full-time
- Responsible for ensuring end-to-end (E2E) management of inspection management-related systems per company’s requirements (e.g., contents & timeline), including but not limited to: CURVE (proper maintenance of inspection information and data); D2 (archive of inspection related information and data); Inspection related SharePoint sites etc.
- Responsible for supporting the coordination of inspection preparation, conduct and post-inspection activities for APAC in the GLP, GCP and PV areas.
- Responsible for extracting, analyzing (under supervision if needed), and presenting general & specific information/data (metrics) on inspections.
- Responsible for supporting activities in monitoring regulatory intelligence focusing on the APAC region and providing support as needed the RDQ Regulatory Intelligence function, e.g., translation of regulations, requirements etc.
- Responsible for supporting CIT Lead to monitor (mining) of external industry and internal J&J inspection outcomes and trends, ensuring this information is proactively shared within R&D Business partners and effectively used to shape the audit and inspection readiness programs.
- Responsible for supporting other activities within APAC inspection team, as needed.
- Responsible for ensuring timely submission of inspection-related information into company databases (e.g., CURVE, D2, COMET, etc.).
- Support manager to resolve strategic business/regulatory issues with franchise, corporate and business group leaders. Global spokesperson and negotiator with Regulatory Authorities.
- Operates with minimal guidance from supervisor.
- Expected to lead and be proactive in the setting of priorities to achieve R&D Quality goals and objectives.
- Reports directly to the Associate Director, APAC Inspection Management
- Works very closely with other R&D Quality functions to ensure the inspection readiness.
- Interacts with quality professionals within R&D Quality and at other J&J companies.
- Interacts as appropriate with functional professionals as needed.
- Requires at least 2-5 years of experience in a quality function working on complex and significant compliance topics. Have comprehensive knowledge of worldwide GCP, GLP, PV, IT & other applicable compliance regulations.
- Demonstrated effective influencing, interpersonal, written and verbal communications skills as well as a proven track record of sustaining compliance in complex organizations. Regulatory Authority experience is desirable.
- BS required. Masters in related field, advanced degree advantages.
- Experience with Regulatory Authorities is a significant asset.