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Commercial Quality & Compliance Specialist at Johnson &… · Irvine
Job Description
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:
QualityJob Sub Function:
Customer/Commercial QualityJob Category:
ProfessionalAll Job Posting Locations:
Irvine, California, United States of America, Raynham, Massachusetts, United States of America, Remote (US), Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of AmericaJob Description:
Johnson & Johnson is currently recruiting for a Commercial Quality & Compliance Specialist (Q&C) to support US Orthopedics Commercial Operations in the United States. This role will be fully remote, remote work may be considered on a case-by-case basis and if approved by the business.
Position Summary:
The Commercial Quality & Compliance Specialist is responsible for the development, execution and oversight of Q&C programs for the orthopedic local operating company in the US. This includes but is not limited to Internal and External Orthopedic Field Inventory Managers & Loaner Distribution Points in the United States. This position will focus on compliance of “last mile” operations that handle and deliver reusable orthopedic medical devices in support of orthopedic customers across the US. This position serves as a liaison with Franchise Quality, Sales, Commercial Operations and Supply Chain partners on commercial and distribution quality related matters to drive timely resolution of quality related issues. This position identifies and supports implementation of fit for purpose quality and compliance improvement opportunities consistent with business objectives, Enterprise Quality Standards, and applicable regulations, while considering the customer experience.
Key Responsibilities:
Establish relationships with DePuy Synthes sales, sales agents, commercial operations, supply chain, distribution and franchise customers to solve problems and meet changing operations and regulatory environments.
Define, implement, and validate quality system requirements and systems to meet departmental and business strategies.
Mentor and coach functional partners in the areas of GxP requirements.
Implement and improve systems/processes with focus on; customer and commercial quality, Inspection readiness, quality planning, nonconformance and corrective/preventive action plan development, implementation and effectiveness monitoring.
Provide quality support for existing and new distribution models & processes in the US.
Guide the Operations on the development of standard operating procedures.
Serve as single point of contact for assigned business partners.
Participate in, host and lead audits, inspections, investigations, and remediation activities.
Qualifications
Education:
Minimum Associates Degree or 3 years experience; (University degree in regulatory compliance or scientific field is preferred).
Experience and Skills:
Required:
Proven experience in a regulated healthcare industry.
Experience in a fast paced, complex operation is required.
Ability to collaborate and communicate concepts in a way that is easily understood.
Self-directed with flexibility to work independently and on teams.
Time and project management skills.
Strong problem solving, root cause analysis and analytical experience.
Knowledge of applicable FDA regulations and ISO-13485 standards.
Preferred: Experience interacting with Health Authority or Notified Body is helpful.
Other:
Central or West US physical location Preferred
Up to 25% travel
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 https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
The anticipated base pay range for this position is :
$79,000.00 - $127,650.00Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s 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