(Senior) Manager, Inspection Management - R&D Quality
At the Janssen Pharmaceuticals Companies of Johnson & Johnson, we are recruiting for a (Senior) Manager, depending on candidate’s qualification and experience, GCP Inspection Management located in China.
This role will report to the Director, GCP (Good Clinical Practice) Inspection Management who in turn reports to the GCP Quality Assurance (QA) APAC Head. Together, we are part of Research & Development Quality Assurance (R&D Quality).
Do you have knowledge, skills and experience in Good Clinical Practices and clinical (GCP)/ clinical audits, leading GCP inspections, and the passion and creativity to shape the future quality landscape? If yes, we want you to join our diverse team here in R&D Quality where you will feel encouraged, supported and challenged to take your career to the next level!
We see the bigger picture and deliver on attention to detail.
Key business partners include: Janssen R&D Therapeutic Areas, Global Development (responsible for clinical operations), JJRC/Pharmaceutical Regulatory Compliance (responsible for oversight of GCP compliance), R&D Quality CAPA Centre of Excellence (responsible for driving the investigation, CAPA development and inspection response activities).
We build strong and trusted relationships with regional, local & global Health Authority Inspectorates to deliver excellence for the end-to-end inspection process. By doing so we enable success by ensuring inspectorates have timely access to the required documents, interviewees, databases and tools.
We handle all inspection phases from start to finish:
• Responsible for providing expert strategy, direction, and advice to R&D business partners related to GCP regulatory requirements.
• Responsible for leading the coordination of inspection preparation, conduct and post-inspection activities for GCP Inspections.
• Responsible for providing strategic direction for communication with Regulatory Authorities post inspection, including the Regulatory Compliance review and input to inspection observation responses prior to submission and the oversight of inspection commitments ensuring documented evidence of completion.
• Responsible for ongoing monitoring (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.
• Support JJRC in the conduct of Special Investigations where specific GCP expertise is needed.
• Responsible for external influencing, working with the regulators, defining key strategies for influencing with global Health Authorities
• Responsible for ensuring timely submission of inspection-related information into company databases (e.g., CURVE etc.).
• Provide input to R&D Quality QA GCP Audit Strategy and collaborate on audits to support inspection readiness.
• Support/Lead R&D Quality QA GCP audits, based on workload or where specific expertise is needed.
• Provides strategic leadership, coaching, and mentoring to colleagues.
Tertiary Qualification e.g., University Degree
Experience and Skills:
• Conduct of GCP quality related activities, study/site monitoring or/and audits
• Requires at least 10 years of experience with 5 plus years’ experience and demonstrated leadership in a quality function working on complex and significant compliance topics
• Leadership in hosting of GCP inspections (e.g., on behalf of a Marketing Authorization Holder/Sponsor)
• Excellent knowledge of local as well as international regulatory standards on the conduct of clinical research (e.g., International Conference of Harmonisation (ICH), US and European Legislations)
• Excellent written and verbal communication skills e.g., communication with Senior Leaders
• Knowledge and/or experience in GVP related activities e.g., audits and inspections, and excellent knowledge of GVP harmonized standards and legislation. (e.g., European legislation, International Conference of Harmonisation (ICH) documents, Council for International Organizations of Medical Sciences (CIOMS)].
• Conduct of GCP inspections on behalf of a national Health Authority
Travel: international travel to inspection location sites is required (up to 30%) although some inspections can be handled remotely