Compliance Lead

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at are searching for the best talent for Compliance Lead to be located in Athens GA.

This position will be accountable for the site internal quality program and external GMP audit and inspection management programs lead and/or coordinate team of site-based compliance personnel to deliver both programs deploy compliance initiatives for the site in alignment with Innovative Medicine Regulatory Compliance.

Key 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

Education:

• Bachelors Degree in Science or related field is required.

Experience and Skills:

Required:

• At least 7 years related experience in a GMP-regulated industry and at least 2 years of regulatory compliance experience.

• Extensive knowledge of global GMP regulations

• Experience performing internal or external audits.

• Strong analytical skills and ability to clearly articulate issues.

• Must have excellent communication skills able to quickly build credibility within the Quality and Compliance community and management.

• Delivers on commitment timelines and has high sense of urgency.

• Experience preparing for inspections managing inspections and/or supporting inspections

Preferred:

• People management experience

• Change agility and experience working in a matrix organization

• Experience in change management and project management.

Other:

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

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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