· Execute internal audits (schedule, issue agenda, prepare, conduct audit, issue report)
• Execute compliance walk-throughs (e.g. GEMBA)
• Evaluate responses to internal audits
• Enter internal audit data into COMET
• Enter GEMBA findings into the appropriate database
· Facilitate and/or support external GMP audits and inspections (Health Authority, Customer). Including:
• Inspection Readiness (audit preparation, schedule and manage mock inspections, SME coaching)
• Partner with Quality to manage inspections (host and/or coordinate front room and back room, daily inspection summaries)
• Review site response and associated CAPA for Health Authority inspections.
• Provide input to daily inspection summaries, as needed.
· Identify changes in regulations that impact compliance procedure, perform gap analysis against current practices. Implement J&J Compliance Standards (e.g. Audit/Inspection Management) and partner with sites on J&J standard implementation.
· Provide Compliance Subject Matter Expertise (SME) for site personnel, Quality Systems and/or projects. As needed, review complaints and field actions.
· Represent Regulatory Compliance at Site Management Reviews, CAPA Review Boards, Escalations, Platform Compliance meetings, etc.
· Partner with site for execution of proactive compliance scans.
· Partner with site and segment personnel (e.g. Regulatory Affairs, Operations, Product Quality Management, etc.) to proactively identify risks and drive compliance improvement across the site.
· As applicable, monitor progress of site compliance remediation plans (e.g. MCAP, SDCAP, etc.)
· Collaborate with other groups in IMRC and JJRC to support execution of independent audits and special investigations. Support site during ERC audits (e.g. document review, front/back-room support). Review and provide input to site response, and associated CAPA, to ERC audits.
· Ensure timely and accurate reporting of compliance metrics.
· Lead the Inspection Readiness Governance meetings.
· Coordinate compliance training for the site.
· Connect with external groups to benchmark industry standards.
· As needed, co-authors, review, and revise compliance procedures.
· As needed, review (not approve) significant manufacturing and laboratory investigations, confirmed complaints and S1/S2 Field Actions.