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DESCRIPTION

This position will execute the internal audit program at the Xian site, prepare and manage external GMP audits and inspections (e.g. Health Authority, Customer, ERC, etc.), provide compliance subject matter expertise to the manufacturing site and site-based projects, deploy compliance initiatives for the site in alignment with Innovative Medicines Regulatory Compliance.

RESPONSIBILITIES

• 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.