Senior Compliance Lead

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

Job Function:

Quality

Job Sub Function:

Quality & Compliance Audit

Job Category:

Professional

All Job Posting Locations:

Geel, Antwerp, Belgium

Job Description:

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 https://www.jnj.com.

Objectives and Responsibilities

Accountable for the Geel site internal audit program and external GMP inspection management (e.g. Health Authority, Customer).

Acting as compliance Subject Matter Expert and deploy compliance initiatives at the Geel site in alignment with the Pharmaceutical Regulatory Compliance strategy.

Coordinate team of Geel-based compliance personnel

Support the compliance teams of Beerse, Geel, Athens and Cork SM to deliver the site internal audit program and external GMP inspection management program.

Responsibilities IMRC Compliance Lead for Geel

• 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 (e.g. IWR)
• Evaluate responses to internal audits
• Enter internal audit data in 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 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.
• 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 s