Manager, Source Regulatory Compliance

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

Job Function:

Legal & Compliance

Job Sub Function:

Enterprise Compliance

Job Category:

People Leader

All Job Posting Locations:

Albany, New York, United States of America, Albany, New York, United States of America, Albuquerque, New Mexico, United States of America, Anchorage, Alaska, United States, Annapolis, Maryland, United States, Athens, Georgia, United States of America, Augusta, Georgia, United States, Austin, Texas, United States, Baton Rouge, Louisiana, United States, Bismarck, North Dakota, United States, Boise, Idaho, United States, Boston, Massachusetts, United States of America, Burlington, Vermont, United States, Charleston, West Virginia, United States, Columbia, South Carolina, United States, Columbus, Ohio, United States, Concord, New Hampshire, United States, Denver, Colorado, United States, Des Moines, Iowa, United States, Dover, Delaware, United States, Fort Pierce, Florida, United States, Harrisburg, Pennsylvania, United States, Hartford, Connecticut, United States, Helena, Montana, United States, Honolulu, Hawaii, United States { 26 more}

Job Description:

Johnson & Johnson is currently seeking a Manager, Source Regulatory Compliance to join our Source Compliance team located in Raritan, NJ.

Remote work options may be considered on a case-by-case basis and if approved by the Company. This is a remote role available in all states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

The Manager, Source Regulatory Compliance, reports to the Sr Manager, Source Regulatory Compliance, and is primarily responsible for ensuring the robust implementation and sustainability of the compliance programs designed to protect our customers utilizing the SRC processes to proactively engage with suppliers to develop and implement robust Supplier Audit Responses as well as support attainment of strategic goals and objectives.

Key responsibilities:

• Partner with team members (e.g., Source Quality, Source, Franchise Quality, Quality Systems, Manufacturing, and other business functions.)
• Proactively engage with suppliers to develop a robust Supplier Audit Response.
• Tracks Supplier action plans to closure and issue Follow Up Reports to Leadership in accordance with procedural requirements
• Drive compliance performance improvement of suppliers by identifying capability challenges and working with Source Quality in the development of quality improvement plans.
• Ensure execution of purchasing controls for suppliers
• Support the creation of strategic quality and compliance goals, assure management oversight and governance, and drive organizational capabilities to build compliance expertise and guidance.
• Provide periodic data and analytics to our business partners
• Assure compliance with regulatory requirements and internal Johnson and Johnson and Medical Device procedures by supporting Internal and External Audits
• Ensure and maintain a state of inspection readiness for records within area of responsibility
Provide visibility on new Health Authority regulations or changing expectations

The Manager, Source Regulatory Compliance is highly visible to the QC Leadership team and ensures understanding and alignment around compliance with all Federal, State, local and Company regulations, policies, and procedures for our global supply base.

Qualifications:

• A minimum of a Bachelor’s degree in Business, Life Science, Physical Science or Engineering is required.
• Advanced degree in an applicable field of study or certification is preferred.
• A minimum of 6 years of combined experience in Regulatory, Compliance, Quality Management and/or Operations in Medical Devices, Consumer, or pharmaceutical environment.
• Experience in actively participating in FDA or other Health Authority inspections.
• Outstanding communication (written and verbal), persuasion and leadership skills.
• Ability to listen, learn, guide, and think strategically are traits that are required for success in this role.
• Support Quality and Regulatory solutions and applications in a fast-paced changing business environment.
• Ability to connect, influence and effect change.
• Ability to engage senior management in identifying critical needs and to ensure effective deployment across the sector.
• Able to work remotely and partner globally.
• Ability to lead and influence others in a complex organization.
• Up to 10% domestic and international travel may be required as business demands.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$100,000-$172,500

Additional Description for Pay Transparency:

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)). 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. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.