Job type: Full-time

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Janssen Supply Group, part of the Johnson & Johnson family of companies, is currently recruiting for a Large Molecule Regulatory Compliance Lead to be located in any Janssen location in EMEA.

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 Supply Group, LLC is part of the Janssen Pharmaceutical Companies.

Position Summary

The Large Molecule Regulatory Compliance lead is accountable for regulatory compliance of the Large Molecule Platform within the Janssen Supply Chain. The Lead is responsible for compliance oversight and execution of key compliance programs to drive proactive and sustained compliance, in order to enable delivery of business needs. The Lead directs a team(s) of compliance professionals to execute tactical compliance activities.

Major Duties & Responsibilities
  • Serve as an expert regulatory compliance advisor and Subject Matter Expert on key strategic and critical compliance issues for the Large Molecule Platform.
  • Understand site risk profiles and proactively identify and prioritize risks. Partner with stakeholders to escalate critical risks to the appropriate levels of management.
  • Provide compliance expertise and global compliance perspective in the development of risk mitigation strategies. Make decisions regarding the applicability of cGMP and other Health Authority regulations to sites in the Large Molecule network.
  • Lead a team(s) of compliance professionals to provide compliance oversight and execute compliance programs to ensure compliance with all voluntary, regulatory, and statutory standards.
  • Represent Large Molecules Regulatory Compliance in applicable Q&C and/or JJRC forums and councils. Act as deputy for Large Molecules Regulatory Compliance Head.
  • Understand and communicate emerging external regulatory compliance issues and trends.
  • Establish organizational talent strategy to include goals and objectives, performance and development and career and succession planning.
  • Accountable for performance management, personnel development and timely completion of 5 Conversations.
  • Establish a high performance and continuous improvement culture driven by key performance metrics, benchmarking and sharing of best practices.
  • As applicable, conduct and/or facilitate assessments (e.g., Pre-PAI Audits, Due Diligence Audits, Gap Analyses) to support business needs and assess compliance risk for the organization.
  • Partner with stakeholders to drive implementation of new and revised regulatory requirements and expectations.

Qualifications
  • A minimum of a bachelor’s degree in science or another related field is required
  • A minimum of 10 years of experience in Quality Assurance, Operations, and/or Regulatory Compliance is required, working with large molecule (e.g. biotechnology, cell therapies and/or vaccines) is preferred.
  • Experience managing various aspects of Quality and Regulatory Compliance is required
  • Experience working in the Pharmaceutical, Medical Device, or Consumer regulated healthcare environment is required
  • Detailed knowledge of Pharmaceutical sector regulatory requirements is preferred
  • Experience working with, or for, the United States Food and Drug Administration (FDA) and other foreign regulatory agencies is required.
  • Demonstrated track record of achieving successful compliance outcomes, remediating compliance issues and supporting regulatory agency inspections is required
  • Ability to build partnerships, manage complexity and mediate issues is required
  • Utilizing influential leadership, the ability to build consensus and impact outcomes without always having line authority; able to negotiate trade off decisions across the organization is required
  • Strong analytical skills and experience implementing risk-based oversight programs is required
  • Strong executive presentation skills are required
  • Demonstrated track record of leading direct or indirect teams to delivers results is required
  • Ability to balance technical understanding of products and processes with compliance perspective and business acumen is required
  • This position can be located in any Janssen location in EMEA and may require up to 40 percent of travel both internationally and domestically. Work location is flexible if approved by the Company.

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 the basis of disability.

Primary Location

Netherlands-South Holland-Leiden-

Other Locations

North America-United States-New Jersey, Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen

Organization

Janssen Vaccines & Prevention BV (8852)

Job Function

Quality

Requisition ID

2105983794W

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Deadline: 05-05-2024

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