AdresExternal Manufacturing Compliance Principal - 2406177644W
Description
Janssen Supply Group, part of the Johnson & Johnson Family of Companies is recruiting for an External Manufacturing Compliance Principal.
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
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The Compliance Principal is accountable for regulatory compliance oversight of External Manufacturers within the J&J External Supply Chain. The Compliance Principal is responsible for the execution of key compliance programs to drive proactive and sustained compliance that enable delivery of business objectives.
This individual serves as a global resource and provides expert cGMP/GXP compliance oversight for J&J’s external supply chain. This is inclusive of External Manufacturers and Suppliers regulated by international health authorities and regulatory agencies. They will provide compliance subject matter expertise for significant investigations, inspections, and projects that span the external supply chain.
The Compliance Principal partners closely with External Quality leadership to assure compliance programs are implemented and maintained. They will collaborate with cross functional partners to prepare, manage, and respond to health authority inspections at External Manufacturing sites, support external manufacturer qualification activities, and due diligence assessments.
Main responsibilities will include, but are not limited to:
Serve as an experienced regulatory compliance advisor and Subject Matter Expert on key strategic and critical compliance issues.
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 External Manufacturing sites.
Partner with operating units to identify, prioritize and ensure implementation of new and revised regulatory requirements and expectations. Support implementation plans for regulatory requirement changes including routine monitoring and verification of implementation activities.
Partners with JSC Supplier Quality leadership to provide compliance oversight and execute compliance programs to ensure compliance with all voluntary, regulatory and statutory standards. Represent Regulatory Compliance in applicable Q&C and/or JJRC forums and councils.
Implement the External Quality Internal Audit Program, follow-ups to Enterprise Regulatory Compliance audits, Significant Regulatory Inspections and Regulatory Actions. Partner with stakeholders to drive effective, sustainable action against associated action plans. Understand and communicate emerging external regulatory compliance issues and trends.
Additional responsibilities:
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.
Provide compliance support to other suppliers as well as internal J&J sites and other J&J projects and initiatives.
Participate in cross-functional investigations and root cause analysis, support the timely development of a CAPA plan
Train/mentor others regarding interpretation of regulatory requirements risk management and compliance activities
Manage / lead projects with independence, ensure timely and accurate completion of activities
Qualifications
Qualifications:
Bachelor's degree is required; preferably in a scientific, medical or related field. Advanced degree preferred.
A minimum of 10 years of experience working in the health care industry required; External Manufacturing experience preferred.
Experience managing various aspects of Quality and Regulatory Compliance in an international, global context required
Experience working in the Pharmaceutical, Medical Device, or Consumer regulated healthcare environment.
Detailed knowledge of Pharmaceutical sector regulatory requirements.
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.
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.
Ability to balance technical understanding of products and processes with compliance perspective and business acumen.
Flexibility to respond to changing business needs required.
Proficient in Microsoft Office Applications required.
Experience presenting to senior leaders
Travel 15-30% primarily domestic and/or international required.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Primary Location Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Other Locations NA-US-Pennsylvania, Europe/Middle East/Africa-Switzerland-Zug-Zug, NA-US-New Jersey, Europe/Middle East/Africa-Italy-Lazio-Latina, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-Ireland-Cork-Cork
Organization Janssen Pharmaceutica N.V. (7555)
Job Function Enterprise Compliance
Req ID: 2406177644W
