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Commercial Quality Staff Engineer
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:
Supply Chain EngineeringJob Sub Function:
Quality EngineeringJob Category:
Scientific/TechnologyAll Job Posting Locations:
Shepherdsville, Kentucky, United States of America, Somerset, New Jersey, United States of AmericaJob Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at
We are searching for the best talent for Commercial Quality Staff Engineer to work onsite at Somerset, NJ and/or Shepherdsville, Kentucky.
The Commercial Quality Staff Engineer is responsible for the oversight and execution of Quality Management Systems and compliance at the U.S. Pharma Distribution Centers. The Quality Engineer provides leadership and support of investigations, validations, quality system improvements, and audit readiness for the Distribution Center. Also monitors and reports on all quality system categories to assess compliance to GxP, regulatory, and standards.
The Commercial Quality Staff Engineer serves as a single point of contact to the Commercial Quality Manager and Supply Chain partners on compliance related matters and is the liaison with multiple quality compliance organizations to drive timely resolution of quality and compliance related issues. Also, identifies business issues, identifies opportunities to continuously improve quality and compliance and leads improvement opportunities and problem solutions. The Quality Engineer implements and executes quality and compliance programs to ensure effective and consistent processes with established standards.
Key Responsibilities:
Promote culture of continuous quality improvement and provide visibility to quality system performance through accurate metrics and reports.
Supports the U.S. Pharma Customer Support Services Team with quality and compliance related matters and Delivery Service Issues (DSIs).
Support internal and external quality system audits.
Supports process qualification activities by developing and/or approving validation documentation.
Leads quality and compliance projects as needed.
Participates in developing and presenting departmental materials for Management review.
Assists project teams with identification of quality system requirements to ensure compliance.
Leads and supports Master Data, i.e., sIDMa, activities for the Distribution Center and provide quality support for the U.S. Pharma Distribution Centers.
Drives innovation within functional areas while ensuring functional initiatives are delivered in a compliant and safe manner.
Identifies opportunities to continuously improve quality, cost, and time factors, consistent with both Janssen Commercial Quality and DELIVER Supply Chain business objectives.
Identifies business issues, communicates to management, prioritizes for action, and leads improvement, and opportunities and problem solutions in collaboration with other Supply Chain partners.
Responsible for monitoring of material destruction authorization (MDA) process.
Responsible for audit inspection readiness activities and assisting in Health Authority and Regulatory Inspections including, but not limited to, TSA, DEA, FDA, and VAWD.
Responsible for partnering with TS (Technology Services) on warehouse management system changes and testing activities.
Serve as single point of contact to internal and external partners on Distribution Quality related matters and liaise with multiple Quality organizations to drive timely resolution of Quality related issues.
Responsible for adherence to the Deviation, Corrective and Preventative Action (CAPA), and Change Controls processes and Quality Management Systems.
Additionally, responsible for review and approval of records.
Responsible for adherence to the Records Management and Retention processes.
Responsible for adhering to the Training process.
Responsible for supporting the Quality Agreement process.
Responsible for supporting internal and external audits, including scheduling, planning, conducting, and follow-up activities.
Responsible for providing quality and compliance oversight for execution of Protocols.
Responsible for notifying/escalating critical quality issues to management in a timely manner.
Responsible for providing data/information/metrics to management for Quality System Management Reviews.
Responsible for development, review, and approval of Standard Operating Procedures (SOPs), Work Instructions (WI) and other documents, as needed.
Responsible for performing gap assessments in local procedures to Johnson and Johnson Global Standards, Business processes, and External Standards and to remediate gaps.
Responsible for the support of New Product Launch activities at the Distribution Center including Master Data (sIDMa) set-up.
Responsible for ensuring Compliance and remaining current with local, state, federal, and international regulations and standards.
Responsible for evaluating overall Compliance risk, recommending, implementing corrective actions, and tracking progress.
Responsible for making quality decisions based upon assessments of compliance risks balanced with the overall business needs.
Responsible for supporting the 24/7 operations of the Distribution Center.
Qualifications
A minimum of Bachelor’s Degree is preferred.
A minimum of 6 years of experience in a highly regulated industry is required.
Quality and compliance experience in the Medical Device, Pharmaceutical or Consumer products industry and experience in distribution is preferred.
Strong communication, teamwork, problem solving, decision-making, and root cause analysis skills are required.
Experience with Warehouse Management Systems and SAP is preferred.
Experience with Quality Event Management Systems such as Comet and/or EtQ is preferred.
Proficiency in organizational and project management skills is preferred.
Experience with Temperature Control is preferred.
This position may require a 10% of domestic 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, please contact us via or contact AskGS to be directed to your accommodation resource.
#LI-Onsite
Required Skills:
Preferred Skills:
Coaching, Consistency, Controls Compliance, Critical Thinking, Data Savvy, Engineering, Financial Competence, Good Automated Manufacturing Practice (GAMP), ISO 9001, Lean Supply Chain Management, Leverages Information, Process Improvements, Quality Control Testing, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Technologically SavvyThe anticipated base pay range for this position is :
$94,000.00 - $151,800.00Additional 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
For additional general information on Company benefits, please go to: -
