Sr Quality & Compliance Specialist

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. Job Function: Quality Job Sub Function: Quality Assurance Job Category: Professional All Job Posting Locations: Remote (US), West Chester, Pennsylvania, United States of America Job Description: Johnson & Johnson is currently recruiting for a Senior Quality & Compliance Specialist! This role can be performed fully remote throughout the US. Remote work may be considered on a case-by-case basis and if approved by the business.

Summary: The Senior Commercial Quality Specialist is responsible for the development, execution and oversight of Quality and Compliance (Q&C) programs for the orthopedic last mile operations network within the United States. This may include internal and external orthopedic last mile Field Inventory operations, Loaner Sites, and Distribution Centers (DC) supporting delivery of Field Inventory & surgical loaner sets to orthopedic customers across the US. This position resides in the DePuy Synthes Commercial Quality Major Markets  Organization. This position collaborates with and serves as a liaison between Quality, Supply Chain, Deliver, Sales and Commercial partners on distribution and commercial quality related matters to drive timely resolution of quality related issues. This position identifies and supports implementation of improvement opportunities consistent with DePuy Synthes business objectives and applicable regulations. The Senior Quality and Compliance Specialist initiates and supports proposals and programs designed to ensure effective and consistent processes with established standards by performing the following duties personally or through work stream groups.  Key Responsiblities: Define, implement, and validate quality requirements and systems to meet departmental strategies. Serve as single point of contact for assigned operations. Host and lead audits, inspections, investigations, and remediation activities. Ensure the Quality program maintains regulatory compliance. Provide quality support for existing and new distribution processes and go to market models. Development, implementation and review of standard operating procedures. Establish and maintain relationships with orthopedic last mile operations and Franchise customers to solve problems and meet changing competitive and regulatory environments. Be a change agent. Execute and improve systems/processes in the following areas: Inspection readiness Process changes Validation, Calibration and Preventive Maintenance systems, as applicable Delivery service issues. Nonconformance investigation and corrective action plan development, implementation and effectiveness monitoring. Coaching and mentoring other functional areas in the areas of ISO and cGMP requirements as needed.

Education: A minimum of a Bachelors or equivalent University degree is required.

6-7years of relevant work experience in a regulated healthcare, medical device, pharmaceutical, consumer products, distribution, commercial quality, or quality systems environment. Working knowledge of applicable FDA regulations CFR 820, ISO 13485, ISO 9001, and quality system requirements relevant to medical devices, commercial