Manager, Product Life Cycle TQ&C - Johnson and Johnson

Johnson and Johnson Services Inc. is recruiting for a Manager, Product Life Cycle TQ&C, located in Raritan, NJ or Horsham, PA!

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 https://www.jnj.com/.

The Leader of Product Lifecycle Management/Regulatory/Learning Management Systems, is responsible for building and execution of quality into enterprise wide systems, tools, services and infrastructure through the end-to-end lifecycle (design, develop, implement, maintain, retire). Individual must be located near the New Jersey (Raritan) or Pennsylvania (Horsham) to support customers.
Key Responsibilities:

• Ensuring that all J&J quality standards and global regulatory requirements are being met.
• Build and execute activities including early involvement of quality in the design and development activities, building quality into the work product, building controls within the application/solution, and use of automation.
• This individual will lead the quality approach for systems and ensure teams are accountable for delivering on an end-to-end support model for systems in scope.
• The role provides technical and procedural expertise/guidance to the project teams as well as aligning with both internal and external partners.
• This position will support internal audits and Health Authority regulatory inspections.
• This position will be responsible for the approval of SDLC validation documentation including the approval to release system implementation and/or changes for production use.
• This role will lead globally diverse teams in an inclusive environment.
• This role serves as a trusted partner across the Technology Quality & Compliance organization, requiring strong collaboration skills at the senior leadership level, and includes making recommendations for improvements relevant to senior level partners.
• Works with TQ&C leadership and pillar leaders to nurture future leaders and create opportunities to grow
• Manages and leads a globally diverse team across geographies, including FTEs and contractors, within a matrixed organization
• Manages and mentors talent and helps them grow in their careers

Education:

• A minimum of a Bachelor's degree in Computer Science, Engineering, Information Systems, Business Administration or other related field required; advanced degree preferred; additional certifications a plus

Experience and Skills:

Required:

• A minimum of 6 years of progressive experience in the pharmaceutical, medical device, biotech industry, with direct experience in Healthcare Technology activities
• Experience in running large scale end-to-end Validation programs like PLM, Regulatory, LMS, and Change Control is required
• Experience authoring or approving validation protocols, non-conformities, Change Requests, SOPs, Validation Plans and Reports is required
• Proficiency in skills including, Quality Strategy, Applications and Infrastructure, Data Integrity, Quality Theory, Testing, Quality Management Systems
• Familiarity and awareness of cybersecurity and privacy principles and implications for quality and risk management
• Advanced understanding of Global and Regional GxP Regulations
• Solid understanding of PMO, SDLC, GAMP 5, and ITIL frameworks is highly desirable
• Knowledge of GxP regulations, including computer system validation, data integrity and medical device regulations
• Solid grasp of Agile Development Methodology and DevOps
• Sets vision and ensures adoption for how quality will be designed into and maintained within a technology solution
• Identifies critical skills and capabilities required to ensure the development of a highly skilled, high performance team
• Responsible for the development of direct/indirect reports including training and mentoring to meet current and future business needs

Preferred:

• Strong collaboration, interdependent partnering and influence skills

Other:

• This position is expected to up to 10% travel with a mix of domestic and international
• The salary for this position is anticipated to be between $95,000 to $155,000
• 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)).
• This position is eligible to participate in the Company's long-term incentive program.
• 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 www.careers.jnj.com .