Compliance Lead

Role Summary

The Compliance Lead, based in Athens, GA, is responsible for the site internal quality program and external GMP audit and inspection management. You will lead and coordinate a team of site-based compliance personnel to deliver both programs and deploy site-wide compliance initiatives in alignment with Innovative Medicine Regulatory Compliance.

Responsibilities

• Responsible for site internal audit program including:
  • Establish and create schedule
  • Auditor training (qualify and evaluate)
• Execute internal audits (schedule, issue agenda, prepare, conduct audit, issue report)
• Execute compliance walk-throughs
• Evaluate responses to internal audits
• Enter internal audit data into Comet
• Maintain site inspection readiness program for external GMP audits and inspections (Health Authority, Customer). Including:
  • Facilitate inspection management (front room, back room, coaching)
  • Lead the site response efforts including assignment of appropriate CAPAs
  • 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 Stds (e.g. Audit/Inspection Mgt) and partner with the site on J&J standard implementation
  • Provide Compliance Subject Matter Expertise (SME) for site personnel, Quality Systems and/or projects
  • Ensure appropriate and timely escalation of risks to the appropriate leadership and regulatory compliance teams. Facilitate remediation of compliance risks
  • Represent Regulatory Compliance at Site Management Reviews, CAPA Review Boards, Escalations, Platform Compliance mtgs, etc.
  • Partner with site for execution of proactive compliance scans
  • Partner with site and segment personnel (e.g. Regulatory Affairs, Operations, Product Quality Mgt, etc.) to proactively identify risks and drive compliance improvement across the site
  • Establish a high performance and continuous improvement culture driven by key performance metrics, benchmarking and sharing of best practices
  • As applicable, report 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 assessments. 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
  • Coordinate, maintain, report and drive site compliance metrics
  • Establish department policy, standard operations procedures and working practices
  • Coordinate compliance training for the site
  • Connect with external groups (e.g. PDA, ISPE, etc.) to benchmark industry standards
  • As needed, provide training for Quality concepts and/or systems
  • 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

Qualifications

• Required: At least 7 years related experience in a GMP-regulated industry and at least 2 years of regulatory compliance experience.
• Required: Extensive knowledge of global GMP regulations.
• Required: Experience performing internal or external audits.
• Required: Strong analytical skills and ability to clearly articulate issues.
• Required: Excellent communication skills, able to quickly build credibility within the Quality and Compliance community and management.
• Required: Delivers on commitment timelines and has high sense of urgency.
• Required: Experience preparing for inspections, managing inspections and/or supporting inspections.
• Preferred: People management experience.
• Preferred: Change agility and experience working in a matrix organization
• Preferred: Experience in change management and project management

Education

• Bachelor's Degree in Science or related field is required.

Skills

• Required: Agile Internal Audit
• Required: Analytical Reasoning
• Required: Audit and Compliance Trends
• Required: Compliance Frameworks
• Required: Compliance Management
• Required: Compliance Policies
• Required: Critical Thinking
• Required: Process Improvements
• Required: Quality Auditing
• Required: Quality Control (QC)
• Required: Quality Standards
• Required: Regulatory Compliance
• Required: Risk Compliance
• Required: Risk Management
• Required: Technical Credibility
• Required: Third-Party Auditing
• Preferred: People management experience
• Preferred: Change agility and experience working in a matrix organization
• Preferred: Experience in change management and project management

Additional Requirements

• Requires up to 10-15% domestic/international travel.