\\n 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.

Key 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

Education:

• A minimum of a bachelor\\xe2\\x80\\x99s degree in science or another related field (required)

Experience & Skills

Required:

• A minimum of 10 years of experience in Quality Assurance, Operations, and/or Regulatory Compliance
• Experience managing various aspects of Quality and Regulatory Compliance
• Experience working in the Pharmaceutical, Medical Device, or Consumer regulated healthcare environment
• Experience working with, or for, the United States Food and Drug Administration (FDA) and other foreign regulatory agencies
• Demonstrated track record of achieving successful compliance outcomes, remediating compliance issues, and supporting regulatory agency inspections
• Ability to build partnerships, manage complexity and mediate issues
• 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
• Strong analytical skills and experience implementing risk-based oversight programs
• Strong executive presentation skills
• Demonstrated track record of leading direct or indirect teams to delivers results
• Ability to balance technical understanding of products and processes with compliance perspective and business acumen

Preferred:

• Experience working with large molecule (e.g. biotechnology, cell therapies and/or vaccines)
• Detailed knowledge of Pharmaceutical sector regulatory requirements

Other:

• This position may require up to 40 percent of travel both internationally and domestically.

At Johnson & Johnson, we\\xe2\\x80\\x99re on a mission to change the trajectory of health for humanity. That starts by creating the world\\xe2\\x80\\x99s 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.

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.

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.\\n \\n \\n \\n \\n \\n

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