Sr Manager - Product Risk Management

Sr Manager - Product Risk Management - 2406191656W
• Description
• J&J Innovative Medicine a member of the Johnson & Johnson Family of Companies and is recruiting for a
• Sr. Manager Product Risk Management and Product Quality Management (PQM) Support
• ! This position can be located in any of the J&J Innovative Medicine sites such as Titusville, NJ, Horsham, Raritan, NJ, PA, Beerse, Belgium, or Leiden Netherlands Schaffhausen, Switzerland, Cork, Ireland, Leiden, Netherlands, Latina, Italy, Gurabo, Puerto Rico, Geel, Belgium!
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 nj.com/ .
The Sr. Manager Product Risk Management and PQM Support is responsible for ensuring robust processes enabling effective implementation of risk management throughout product lifecycle with a key goal of producing high quality products and mitigating risks.
• Key Responsibilities:
• + Provides leadership and oversight to ensure the use of quality principles and tools to manage and optimize the robustness and consistency for Product Risk Management (PRM) processes.
• Provides strategic direction on the implementation of efficient PRM processes ensuring compliance and consistency with ICH Q9 and ISO 14971 risk management principles.
• Responsible for the deployment of PRM processes within J&J Innovative Medicine and resolution of process execution challenges through collaboration with internal customers.
• Leads and facilitates data driven product risk assessments to manage potential risk during development and commercialization.
• Engages in global councils and enterprise forums, ensuring PRM business needs are represented.
• Leads PQM operational improvement projects through structured project management methodology.
• Manages, coordinates, and provides oversight on assigned quality system processes as needed to support PQM.
• Influences through others to make the case for change and builds support for proposed solutions. Coordinates and drives implementation of continuous improvement and efficiencies through building positive relationships across functions, to meet unified business objectives.
• Partners with sponsors to obtain cross-functional and multi-site consensus and support for project activities, champions the usage and benefits of FPX and other project management approaches and mentors others on their effective application.
• Builds trust with others and seeks to discuss difficult issues or concerns openly and respectfully.
• Qualifications
• Education:
• + A Minimum of a Bachelor's or equivalent University degree is required with a focus in Pharmaceuticals, Chemistry, Engineering, Statistics, or other Sciences. Advanced degree (MBA, MS or PhD) is preferred.
• Experience and Skills:
• Required:
• + At minimum of 8 years of related experience in pharmaceutical, biotech, or medical device industry
• Experienced in application of risk assessment methodologies
• Applied knowledge of risk management principles including ISO 14971 and ICH Q9, and cGMP regulations
• Strong interpersonal, planning, and prioritization skills as well as excellent written and verbal communication sills to partner effectively across different levels of our organization
• Preferred:
• + 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 within the United States, is anticipated to be between $115,000 and $180,000
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits:
• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
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 *** .
• Primary Location
• NA-US-New Jersey-Titusville
• Other Locations
• NA-US-Puerto Rico-Gurabo, Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen, NA-US-New Jersey-Raritan, Europe/Middle East/Africa-Belgium-Antwerp-Geel, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, NA-US-Pennsylvania-Horsham, Europe/Middle East/Africa-Italy-Lazio-Latina, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-Ireland-Cork-Cork
• Organization
• JANSSEN SUPPLY GROUP, LLC (6046)
• Travel
• Yes, 10 % of the Time
• Job Function
• Business Process Quality
• Req ID:
• 2406191656W