Manager, Source Reg Compliance (NA)

Johnson & Johnson


Job Location:

West Chester, OH - USA

Monthly Salary: $ 102000 - 177100
Posted on: 6 days ago
Vacancies: 1 Vacancy

Job Summary

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

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality & Compliance Audit

Job Category:

Professional

All Job Posting Locations:

Palm Beach Gardens Florida United States of America Raynham Massachusetts United States of America West Chester Pennsylvania United States of America

Job Description:

DePuy Synthes is recruiting for a Manager Source Regulatory Compliance (NA)locatedinPalm Beach Gardens FL or Raynham MA or West Chester PA.

Job Overview

The Manager Source Regulatory Compliance (NA)is responsible forleading regulatory compliance activities related to sourcing and supplier operations across North America. This role ensures that external manufacturing partners suppliers and sourcing processescomply withapplicable regulatory requirements quality system standards and internal policies. The position plays a critical role in safeguarding product quality supporting audit readiness and enabling compliant supply continuity by partnering closely with Quality Supply Chain Regulatory Affairs and Procurement teams.

Key Responsibilities

  • Lead and manage source regulatory compliance activities across North America ensuring adherence to regulatory and quality system requirements.

  • Provide regulatory and compliance oversight for suppliers contract manufacturers and sourced components.

  • Partner with Supply Chain Procurement and Quality teams to ensure compliant supplier qualification monitoring and lifecycle management.

  • Interpretregulatory requirements and translate them into sourcing and supplier compliance expectations.

  • Support internal audits external audits and health authority inspections related to sourcing and supplier compliance.

  • Monitor compliance risks trends and performancemetrics;drivecorrectiveand preventive actions.

  • Ensure consistent application of global and regional compliance policies procedures and controls.

  • Drive continuous improvement initiatives to strengthen supplier compliance and sourcing governance.

Qualifications

Education:

  • Bachelors degree in Regulatory Affairs Quality Engineering Life Sciences Supply Chain ora relateddiscipline (required).

  • Advanced degree in a scientific regulatory or business field (preferred).

Experience and Skills

Required:

  • Typically6-8 years of progressive experience in Regulatory Compliance Quality Supply Chain or related roles within a regulated industry.

  • Strong working knowledge of regulatory and quality requirementsimpactingsourcing and supplier operations.

  • Experience supporting supplier audits inspections and compliance assessments.

  • Ability to manage complex compliance topics across crossfunctional stakeholder groups.

Preferred:

  • Experience in medical devices healthcare or other highly regulated industries.

  • Familiarity with North America regulatory and sourcing compliance requirements.

  • Experience working in a global or matrixed organization.

  • Exposure to regulatory inspections involving supplier or contract manufacturing oversight.

  • Quality or Regulatory certifications (e.g. RAC ASQ).

  • Strong analytical riskmanagement and problemsolving skills.

  • Effective communication and collaboration skills.

Other:

  • Language: English.

  • Travel: Moderate domestic travel across North America.

  • Certifications: Quality or Regulatory certifications preferred but not.

For more information on how we support the whole health of our employees throughout their wellnesscareerand life journey please visit.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may be required regulatory approvals and other customary conditions and approvals. Should you accept this position it is anticipated that following conclusion of the transaction you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

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 external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

#DePuySynthesCareers

Required Skills:

Preferred Skills:

Agile Internal Audit Analytical Reasoning Audit and Compliance Trends Compliance Frameworks Compliance Management Compliance Policies Compliance Risk Critical Thinking Process Improvements Quality Auditing Quality Control (QC) Quality Standards Regulatory Compliance Risk Management Technical Credibility Third-Party Auditing

The anticipated base pay range for this position is :

$102000.00 - $177100.00

Additional Description for Pay Transparency:

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 Colorado 48 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
Bereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave 80 hours in a 52-week rolling period10 days
Volunteer Leave 32 hours per calendar year
Military Spouse Time-Off 80 hours per calendar year

For additional general information on Company benefits please go to: - Experience:

Manager

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 unique...

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About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more

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