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Job Description:

POSITION SUMMARY:

This Specialist/Sr. Specialist, APAC Inspection Management is 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.

This position is also responsible for supporting the Core Inspection Team Lead to manage Health Authorities inspections in the non-GMP spaces in the APAC region. To extract, analyse (under supervision if needed), and present general & specific information/data (metrics) on inspections. To support activities in monitoring regulatory intelligence focusing on the APAC region and provide support as needed the RDQ Regulatory Intelligence function, e.g., translation of regulations, requirements etc.

PRINCIPAL 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.).

DECISION-MAKING AND PROBLEM SOLVING:

• Support manager to resolve strategic business/regulatory issues with franchise, corporate and business group leaders. Global spokesperson and negotiator with Regulatory Authorities.

INDEPENDENCE/AUTONOMY:

• 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.

REPORTING RELATIONSHIPS:

• Reports directly to the Associate Director, APAC Inspection Management

WORKING RELATIONSHIPS/INTERFACES:

• 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.

KNOWLEDGE, EDUCATION, EXPERIENCE, COMMUNICATION SKILL REQUIREMENTS:

• 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.

RELATED EXPERIENCE:

• Experience with Regulatory Authorities is a significant asset.