Compliance Lead

工作内容

The Pharmaceutical Regulatory Compliance organization is recruiting for a Compliance Lead! This position will be based in Geel.At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Pharmaceutica NV is part of the Janssen Pharmaceutical Companies.Are you interested in making a difference in a growing diverse company? Apply today for this phenomenal opportunity!This position will be accountable for the site internal quality program and external GMP audit and inspection management (e.g. Health Authority, Customer, ERC, etc.), provide compliance subject matter expertise to the manufacturing sites and site-based projects, deploy compliance initiatives for the site in alignment with Pharmaceutical Regulatory Compliance.Key Responsibilities

• Responsible for site internal quality 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. GEMBA)
• Evaluate responses to internal audits
• Enter internal audit data in to TrackWise "
• Maintain site inspection readiness program for external GMP audits and inspections (Health Authority, Customer).
• Facilitate and/or support external GMP audits and inspections. 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 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.
• Coordinate, maintain, report and drive site compliance metrics.
• 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. Facilitate remediation of compliance risks.
• Establish a high performance and continuous improvement culture driven by key performance metrics, benchmarking and sharing of best practices
• As applicable, monitor progress of site compliance remediation plans (e.g. MCAP, SDCAP, etc.)
• Collaborate with other groups in PRC 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.
• Ensure timely and accurate reporting of compliance metrics
• Coordinate compliance training for the site
• Connect with external groups (e.g. PDA, ISPE, etc.) to benchmark industry standards
• As needed, co-authors, review and revise compliance procedures.
• As needed, provide training for Quality concepts and/or systems.
• As needed, review (not approve) significant manufacturing and laboratory investigations, confirmed complaints and S1/S2 Field Actions.
• Conduct Mock Recalls

QualificationsExperience and Skills:Required

• 7 years related experience in a GMP-regulated industry and at least 1 year of regulatory compliance experience.
• Extensive knowledge of global GMP regulations is required.
• Experience performing internal or external audits is required.
• Strong analytical skills. Ability to clearly articulate issues.
• Must have excellent communication skills, able to quickly build credibility within the Quality and Compliance community.
• Delivers on commitment timelines and has high sense of urgency.
• Experience preparing for inspections, managing inspections and/or supporting inspections

Preferred

• Experience in change management and project management.

Other

• Requires up to 10-15% domestic travel
• Potential for limited international travel.

What is in it for you? You will work in a dynamic team in an international and innovative environment with room for personal and professional development. You will have the possibility to gain experience in a variety of tasks with focus on your talents. We offer with this opportunity an attractive salary package including extra-legal benefits such as meal vouchers and medical insurance.The employers of Johnson & Johnson value diversity, equity and inclusion. We are committed to forming teams with varied strengths that reflect both the patients and the partners we support. We strive to create an inclusive work environment where our people feel at home and are given the space to realize their full potential.Primary LocationBelgium-Antwerp-Geel-OrganizationJanssen Pharmaceutica N.V. (7555)Job FunctionQualityRequisition ID2206077503W