Compliance Lead

Johnson & Johnson•Athens, GA

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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 https://www.jnj.com/innovative-medicine We 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.

Requirements

Bachelor's Degree in Science or related field is 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

Nice To Haves

People management experience
Change agility and experience working in a matrix organization
Experience in change management and project management.

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.