Sr. Manager Product Risk Management Team Lead

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 Engineering

Job Sub Function:

Quality Engineering

Job Category:

People Leader

All Job Posting Locations:

Titusville, New Jersey, United States of America

Job 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 https://www.jnj.com/innovative-medicine

We are searching for the best talent for Sr. Manager Product Risk Management Team (RMT) Lead to be located in Titusville, NJ.

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

The Sr. Manager Product RMT Lead is responsible for management, facilitation, and coordination of user interaction product risk management processes by leading the cross functional teams through the process for new product development, launch and lifecycle management. This role drives the application of quality risk management principles and tools to enable effective risk-based decision-making throughout the product lifecycle, with the goal of delivering high-quality products and mitigating risk. The Product Risk Management Team Lead also serves as the decision-support lead for the Risk Management Board, organizing and reviewing product risk files to ensure alignment of conclusions and benefit-risk summaries. In addition, this role identifies and implements process improvement opportunities to advance innovative future-state user interaction product risk management processes.

Key Responsibilities:

• Lead and coach cross-functional Product Risk Management Teams to deliver data-driven Product Risk Assessments (PRA), Failure Mode and Effects Analyses (FMEA), and Product Benefit-Risk Analyses (PBRA) across the product lifecycle, embedding risk-by-design into development and commercialization.

• Chair and coordinate the Risk Management Board (Sr Management Leaders), serving as the decision-support lead to facilitate reviews, prioritize findings, and ensure consistent application of risk management processes and tools across the organization.

• Serve as process owner and subject-matter expert for user interaction Product Risk Management processes, ensuring compliance with ICH Q9, ISO 14971, and related cGMP requirements. Own associated quality system expectations, including CAPAs and change controls.

• Operationalize risk management frameworks, controls, KPIs, and dashboards, and support the development and enhancement of digital risk management platforms (e.g. Cognition Cockpit) and related process integrations (e.g. Global Harms List, Combo Product Control Strategy, Criticality Analysis) to increase visibility and control effectiveness.

• Drive continuous improvement, capability building, and change adoption by leading training, strengthening cross-functional alignment, and applying project management disciplines to deliver initiatives and communicate status to stakeholders and sponsors.

• Collaborate and build trust with Product Risk Management teams to discuss difficult issues or concerns openly and respectfully, embed risk-by-design, influence feature trade-offs, and elevate high-impact risks.

• Lead training, continuous improvement, and cross-functional alignment. Apply project management tools to deliver risk initiatives and governance reporting.

• Model flexibility, adaptability, and leadership behaviors that engage and empower RMT members across their respective roles and responsibilities.

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 least 10 years of related experience in pharmaceutical, biotech, or medical device industry

• Experience in application of risk assessment methodologies

• Applied 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

• An individual with strong interpersonal skills who can communicate effectively with partners across different levels of our organization including Sr management.

Preferred:

• Experience crafting and delivering specific product risk management training across functions

Other:

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

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

#LI-Hybrid

Required Skills:

 

 

Preferred Skills:

Business Process Management (BPM), Coaching, Controls Compliance, Developing Others, Fact-Based Decision Making, Give Feedback, Inclusive Leadership, ISO 9001, Leadership, Lean Supply Chain Management, Process Improvements, Quality Control Testing, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Team Management, Technical Support

 

 

The anticipated base pay range for this position is :

$122,000.00 - $212,750.00

Additional 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)).

This position is eligible to participate in the Company’s long-term incentive program.

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: - https://www.careers.jnj.com/employee-benefits