Commercial Operations - Quality Lead
Brighter Signals
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Benefits offered by this job
Job summary
Johnson & Johnson seeks a Commercial Operations Quality Lead for the Field Sales Network (FSN) in West Chester, PA, within Global Distribution & Commercial Logistics. You will drive quality compliance, CAPA, and audit readiness across a national network of field inventory locations.
The ideal candidate brings 5+ years in quality, regulatory, or medical device environments, strong PM and stakeholder skills, and the ability to travel 25–40%.
Qualifications
- Bachelor’s degree required in engineering, quality, life sciences, supply chain or related field.
- Minimum 5+ years in Quality, Operations, Regulatory, Compliance, Supply Chain, or Medical Device environments.
- Experience managing CAPAs, audits, investigations, observations, or quality systems.
- Strong project and stakeholder management; excellent communication skills.
Responsibilities
- Lead audit readiness across the Field Sales Network (FSN).
- Coordinate internal audits, ERC, JJIA, FDA inspections and other assessments.
- Develop audit plans, opening presentations, readiness docs and site materials.
- Coach site leaders on inspection readiness and best practices.
- Support CAPA execution, investigation remediation and closure.
- Author, revise and approve SOPs, instructions and training materials.
- Drive field actions, recalls, stop shipments and training compliance.
Skills
Education
Tools
Job description
Sales Enablement
Sales Operations & Administration
Business Enablement/Support
Remote (US), West Chester, Pennsylvania, United States of America
About Orthopaedics
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems.
Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
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 plans. In 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.
We are searching for the best talent for the Commercial Operations - Quality Lead in West Chester, PA.
Remote work options may be considered on a case-by-case basis and if approved by the Company.
The Commercial Operations Quality Lead serves as the primary quality partner for the Field Sales Network (FSN), ensuring compliance with Johnson & Johnson quality systems, regulatory requirements, and internal standards across a national network of field inventory locations.
This role partners closely with FSN leadership, site leads, Commercial Quality, Operations Excellence, Facilities, and business process teams to drive audit readiness, quality system compliance, process standardization, corrective and preventive actions (CAPAs), inspection management, field actions, stop shipments, training compliance, and continuous improvement initiatives.
The ideal candidate combines strong quality and compliance expertise with operational leadership, influencing skills, and the ability to develop practical solutions in a dynamic field-based environment.
- Serve as the primary quality representative supporting the Field Sales Network.
- Ensure compliance with internal quality requirements, SOPs, work instructions, and regulatory expectations.
- Maintain oversight of quality metrics, observations, CAPAs, effectiveness monitoring activities, and audit action plans.
- Partner with Commercial Quality to prioritize and close quality observations and compliance gaps.
- Lead audit preparation activities for FSN locations.
- Coordinate internal audits, ERC audits, JJIA audits, FDA inspections, and other compliance assessments.
- Develop audit preparation plans, opening presentations, readiness documentation, and site support materials.
- Coach site leaders and FSN management on inspection readiness and audit best practices.
- Support audit response activities and corrective action execution.
- Drive investigation, remediation, and closure of quality observations.
- Partner with cross-functional teams to develop sustainable corrective and preventive actions.
- Monitor aging metrics and ensure timely execution of commitments.
- Manage effectiveness monitoring activities and ongoing compliance assessments.
- Author, revise, review, and approve SOPs, work instructions, training materials, and operational procedures.
- Maintain process documentation supporting FSN operations, inventory management, facilities compliance, inbound/outbound processing, inventory controls, and quality systems.
- Partner with Operations Excellence to standardize practices across all FSN sites.
- Coordinate field actions, recalls, quarantines, and stop shipment activities across the FSN network.
- Assess inventory impacts and partner with operations teams on execution plans.
- Maintain stop shipment governance processes and reporting.
- Serve as a key liaison between quality, operations, and franchise teams during product holds and recalls.
- Monitor quality training compliance and support remediation of training gaps.
- Develop and deliver training on quality procedures, compliance requirements, and operational standards.
- Promote a culture of quality, inspection readiness, and continuous improvement throughout the FSN organization.
- Partner with FSN leadership, Site Leads, Commercial Quality, Facilities, Supply Chain, Systems, and Franchise Quality teams.
- Provide consultation on operational changes, risk assessments, and quality impacts.
- Influence stakeholders to achieve compliant and practical business solutions.
- Bachelor's degree in Engineering, Quality, Life Sciences, Supply Chain, Business, or related field.
- 5+ years of experience in Quality, Operations, Regulatory, Compliance, Supply Chain, or Medical Device environments.
- Experience managing CAPAs, audits, investigations, observations, or quality systems.
- Strong project management and stakeholder management skills.
- Excellent communication and presentation abilities.
- Ability to travel approximately 25-40%.
- Medical device, pharmaceutical, healthcare, or regulated industry experience.
- Experience supporting audits and regulatory inspections.
- Knowledge of Good Documentation Practices (GDP), CAPA, complaint handling, change control, and risk management.
- Experience with quality systems such as EtQ, Windchill, SAP, Move Medical, Power BI, or similar platforms.
- ASQ certification, Lean/Six Sigma certification, or equivalent quality credentials.
- Audit readiness across the FSN network.
- Reduction in overdue CAPAs and observations.
- Timely closure of quality actions and effectiveness reviews.
- Training compliance performance.
- Successful execution of field actions, stop shipments, and recall activities.
- Quality metric improvement and regulatory compliance outcomes.
- Strong partnership and support of FSN operational objectives.
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 : $63,000.00 - $101,430.00
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: - https://www.careers.jnj.com/employee-benefits
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