Commercial Operations - Quality Lead

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 jnj.com

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.

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.

Position Summary

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.

Process Development & Documentation

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.

Success Measures

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.

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