Commercial Quality Staff Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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.

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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 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 Bachelors 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.

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