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Are you interested in making a difference in a growing diverse company? Apply today for this phenomenal opportunity!

The Pharmaceutical Regulatory Compliance organization is recruiting for a Senior Compliance Lead. This position will be based in Latina site, the most innovative drug product (DP) manufacturing site in the Janssen Supply Chain Small Molecule Platform.

This position will be accountable for the site internal quality program and external GMP audit and inspection management programs, lead team of site based compliance personnel to deliver both programs, drives longer term strategies and ensures alignment with emerging business initiatives, may include leading teams across multiple sites.

Key Responsibilities:

• Implementation of risk-based oversight programs across multiple sites. Responsible for the oversight of multiple aspects of Regulatory Compliance (e.g. HA notifications, inspection management and remediation) in an international/global context. Initiate and implement Quality System changes
• Supervise and assign activities to ensure alignment with business strategy. Lead the Site Compliance organization to achieve short term targets and longer-term strategies
• Develop site compliance programs to ensure compliance with all voluntary, regulatory and statutory standards and establishes training requirements for all employees. Provide input to risk registry for the sites in respective region
• Establish team talent strategy to include goals and objectives, performance and development and career and succession planning
• Establish department policy, standard operating procedures and working practices
• Accountable for performance management, personnel development and timely completion of 5 conversations
• Ensure training plans are also aligned with areas of needed improvement
• Support Quality and Compliance strategy implementation
• Establishes a high performance and continuous improvement culture, driven by key performance metrics, benchmarking and sharing of best practices
• Establish continuous compliance training for the region
• 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. 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). 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 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
• Coordinate, maintain, report and drive site compliance metrics
• Establish department policy, standard operations procedures and working practices
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• 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
• Conduct Mock Recalls

Education:

• Bachelor's Degree in Science or related field

Experience and Skills.

Required:

• At least 8 years related experience in a GMP-regulated industry and at least 3 years of Regulatory Compliance experience
• At least one year of people management experience required
• Extensive knowledge of global GMP regulations is required
• Experience performing internal or external audits is required
• Good knowledge of English (B2 level and above) and Italian (local language)
• Ability to build partnerships and mediate issues while optimizing the value proposition
• 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 executive management
• Delivers on commitment timelines and has high sense of urgency
• Demonstrate business acumen, deal with complexity and ambiguity

Preferred:

• QA/RA certification is preferred. Advanced degree preferred
• Change agility, strong collaboration and influence skills; demonstrated leadership

Other:

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

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.