Principal Quality Engineer, Product Risk Management - 2406161321W

　　Description

　　Janssen Supply Group a member of the Johnson & Johnson Family of Companies is recruiting for a Principal Quality Engineer Risk Management and Product Quality Management (PQM) Support ! This position can be located in any of the J&J Innovative Medicine site such as Titusville, NJ, Horsham, PA, Beerse, Belgium and Leiden, Netherlands. Remote work can be considered on a case by case basis.

　　At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com (file:///C:/Users/jamie yacco/AppData/Local/Microsoft/Windows/Temporary Internet Files/Content.Outlook/JHNHJA6O/www.janssen.com) and follow us @JanssenGlobal. Janssen Supply Group is part of the Janssen Pharmaceutical Companies.

　　The Principal Quality Engineer is responsible for management, execution, and coordination of product risk management processes across functions for new product introduction and lifecycle management.

　　Key Responsibilities:

　　70% of the responsibility:

　　Lead and facilitate data driven product risk assessments to manage potential risk during development and commercializationOther duties:

　　Own product risk management processes in PQM ensuring compliance and consistency with ICH Q9 and ISO 14971 risk management principles

　　Serve as process SME: Resolve process execution challenges through collaboration with internal customers, own relevant CAPA and change controls, provide education to users of the process

　　Makes a positive contribution through collaboration to identify, lead, and participate in PQM operational improvement opportunities.

　　Builds trust with others and seeks to discuss difficult issues or concerns openly and respectfully

　　Drive alignment and efficiencies through building positive relationships across functions, to meet unified business objectives

　　Craft and maintain PQM knowledge management repository such as PQM SharePoint

　　Applies knowledge of project management tools to drive projects from start to completion and communicate the project status to project partners and sponsors

　　Engage in global councils/ enterprise forums, ensuring product risk management business needs are represented

　　Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements

　　Other duties will be assigned, as necessary

　　Qualifications

　　Education:

　　A University Bachelor's degree, or equivalent, is required with a focus in engineering, science, or relevant technical subject preferred.Experience and Skills:

　　Required:

　　A minimum of 8 years of related experience in pharmaceutical, biotech, or medical device industry

　　A minimum of 1 year of Product Risk Management experience specifically in pharmaceutical or med tech

　　Experience in application of risk assessment methodologies

　　Knowledge of risk management principles including ISO 14971 and ICH Q9, and cGMP regulations

　　Good organizational, planning and prioritization skills; excellent written and verbal communication skills

　　Preferred:

　　An individual with strong interpersonal skills who can communicate effectively with partners across different levels of our organization

　　Experience crafting and delivering training across functions

　　Other:

　　Must be proficient in the English language (speak, read & write).

　　This position may require up to 10% domestic & international travel.

　　The salary for this position, if based in the US, is anticipated to be between $95,000 to $155,000

　　Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

　　For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

　　Primary Location NA-US-New Jersey-Titusville

　　Other Locations NA-US-Pennsylvania-Horsham, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse

　　Organization JANSSEN SUPPLY GROUP, LLC (6046)

　　Travel Yes, 10 % of the Time

　　Job Function Business Process Quality

　　Req ID: 2406161321W