Senior Manager, Source Regulatory Compliance

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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 Anchorage Alaska United States Annapolis Maryland United States Atlanta Georgia United States Austin Texas United States Baton Rouge Louisiana United States Bismarck North Dakota United States Boise Idaho United States Burlington Vermont United States Chandler Arizona United States Charleston South Carolina United States Charleston West Virginia United States Colorado Springs Colorado United States of America Columbus Ohio United States Concord New Hampshire United States Des Moines Iowa United States Eugene Oregon United States Fayetteville Arkansas United States Helena Montana United States Honolulu Hawaii United States Horsham Pennsylvania United States of America Indianapolis Indiana United States Irvine California United States of America Jackson Mississippi United States 22 more

Job Description:

Johnson & Johnson is currently seeking a Senior Manager Source Regulatory Compliance to join our Regulatory Compliance team located in Irvine CA; Plymouth MN; Raynham MA; or Miami FL.

Remote work options within the United States may be considered on a case-by-case basis and if approved by the company. 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.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):

Mexico - Requisition Number: R-025960

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

This position will provide Worldwide Source Compliance leadership in the development implementation and continuous improvement of Source Compliance programs associated with Suppliers (External Manufacturers Direct & Indirect Suppliers) associated with the business. They will be responsible for ensuring the post audit activities are executed per established procedures such as Supplier Audit Response support & alignment supplier action plan follow-up & closure EM follow-ups metric reporting and support as needed for the maintenance and continually improvement of the Source Compliance process. They will engage with business partners such as Supplier Quality & supplier relations and addition they will support external audits/inspections at business sites and suppliers as required.

Key Responsibilities:

In accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines this position

• Will establish manage maintain and continuously improve Source Regulatory Compliance activities associated with assigned business Suppliers including but not limited to the following:
  • Working with suppliers to ensure a robust Supplier Audit Response (SAR) & aligning on all second pass SARs.
  • Tracking to completion all supplier audit observations.
  • Execution of Follow-ups for External Manufactures (EMs)
  • Data analysis & Metric reporting.
  • Working with suppliers and internal observation owners to achieve Green supplier audit Metrics.
  • Preparation of Source Compliance slides
  • Partnering with internal partners such as ERC auditors & SPOCs Quality & Supplier relations to establish and maintain robust supplier relationships and supplies.

• Will establish and execute the Compliance strategies for the management of Suppliers.
• Recruit develop and manage direct reports and contractors.
• Support external audits/inspections at sites and suppliers as required.
• Lead Source Compliance input to Executive Management review for the assigned business
• Support the development and review of external Health Authority and notified body responses related to supplier/purchasing control observations to ensure robust investigations corrective actions and timing.
• Provide periodic data and analytics to business partners including compliance data & current global health authority trends that enable the organization can deliver on quality and compliance commitments. Develop proactive approaches to address regulatory trends.
• Provide oversight and compliance review of Suppliers remediation programs
• Lead and/or contribute to strategic Source Regulatory Compliance initiatives and projects
• Provides visibility to the business on new supplier related Health Authority regulations or changing expectations and results of Health Authority inspections.
• Establish and manage the assigned Source Compliance budget.
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health Safety and Environmental practices as applicable.
• For those who supervise or manage a staff responsible for ensuring that subordinates follow all Company guidelines related to Health Safety and Environmental practices and that all resources needed to do so are available and in good condition if applicable
• Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures
• Performs other duties assigned as needed

Qualifications:

• A Bachelors degree in Business the sciences or Engineering is required. A Masters Degree or other Advanced Degree is preferred.
• A minimum of 8 years of combined experience in Regulatory Compliance and/or Quality in Medical Devices or pharmaceutical products is required. Medical Device experience is preferred.
• Strong knowledge of FDA & Global Medical device regulations & Medical device standards such as ISO 13485 is required.
• Knowledge and experience in executing investigations and developing Corrective actions is required.
• Experience in managing professional associates is required.
• Experience working with suppliers is required.
• Ability to engage senior management in identifying critical needs and to ensure effective deployment across the sector is required
• Demonstrated ability to work remotely and partner globally is required.
• Ability to foster an effective multi-functional cross region cross company team environment is required.
• Experience in actively participating in external inspections is preferred.
• Auditing experience especially supplier auditing is preferred.
• Strong communication (written and verbal) skills are required.
• Strong leadership partnering influence negotiation and change management skills are required.
• People leadership Project management problem solving investigation and presentation skills are required.
• Auditor certification is preferred.

Other:

• This position will directly manage the assigned business Source compliance FTEs and contractors
• It is preferred that this position be located at one of the assigned business sites and may require up to 5% domestic & international travel.
• This position will frequently interact with Suppliers (EMs direct & indirect) to explain the post audit process and assist with Supplier audit responses and tracking the completion of actions.
• This position may also have to interact with Health Authorities Notified Bodies and other regulatory agencies during audits/inspections to support inquiries related to suppliers.

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 & 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 () or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$120000-$207000

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees and/or eligible dependents are 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. Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire Employees are eligible for the following time off benefits: Vacation 120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year Holiday pay including Floating Holidays 13 days per calendar year Work Personal and Family Time - up to 40 hours per calendar year Parental Leave 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave 10 days Volunteer Leave 4 days Military Spouse Time-Off 80 hours Additional information can be found through the link -Ops and Intern Positions: Co-Ops/Interns are eligible to participate in Company sponsored employee medical benefits in accordance with the terms of the -Ops and Interns are eligible for the following sick time benefits: up to 40 hours per calendar year; for employees who reside in the State of Washington up to 56 hours per calendar year Co-Ops and Interns are eligible to participate in the Companys consolidated retirement plan (pension) Positions Represented by CBA: This position is eligible for benefits to include medical dental vision and time off as well as any others as provided for in the applicable Collective Bargaining Agreement. 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.