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Johnson & Johnson Innovative Medicine · 1 day ago

Senior Specialist, APAC Inspection Management (Contractor)

Shanghai, VA

Full-time, Contract

Onsite

Mid, Senior Level

2+ years exp

Johnson & Johnson is a leader in healthcare innovation, dedicated to improving health outcomes globally. The Senior Specialist in APAC Inspection Management is responsible for managing inspection-related systems and supporting regulatory compliance activities within the APAC region.

Pharmaceuticals

Responsibilities

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.)

Qualification

GCPGLPPVRegulatory IntelligenceData AnalysisInfluencing SkillsRegulatory AuthoritiesSharePointInspection ManagementInterpersonal SkillsWritten CommunicationVerbal Communication

Required

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

BS required

Masters in related field, advanced degree advantages