External Manufacturing Compliance Principal
External Manufacturing Compliance Principal - 2406215428WDescriptionJanssen Supply Group, LLC. is recruiting for an External Manufacturing Compliance Principal to be located in New Brunswick, NJ, Raritan, NJ, Horsham, PA or near any Johnson and Johnson Innovative Medicine site in the United States.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.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.Responsibilities:
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
QualificationsEducation:
Bachelor's degree is required; preferably in a scientific, medical or related field. Advanced degree preferred.
Experience and Skills:Required:
A minimum of 10 years of experience working in the health care industry required
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
Preferred:
External Manufacturing experience is preferred.
Other:
30-40% travel is required.
The anticipated base pay range for this position is $142,000 to $244,950.The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Employees are eligible for the following time off benefits:
Vacation – up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
This job posting is anticipated to close on 10/7/24. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.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.Primary Location NA-US-New Jersey-New BrunswickOther Locations NA-United States, NA-US-Pennsylvania-Horsham, NA-US-New Jersey-RaritanOrganization JANSSEN SUPPLY GROUP, LLC (6046)Job Function Enterprise ComplianceReq ID: 2406215428W