Job Information
J&J Family of Companies SR Manager, Quality Management Systems Operations in Trenton, New Jersey
SR Manager, Quality Management Systems Operations - 2406215942W
Description
Johnson & Johnson is recruiting for a Senior Manager of Quality Management Systems (QMS) Operations! This position can be performed at any J&J Site in North America, with a preference for Raritan, NJ.
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/._
Position Summary:
Enterprise Quality is a comprehensive organization within J&J that focuses on ensuring the highest standards of quality & compliance. It encompasses a Quality Operations division that supports QMS Management and Commercial Quality Shared Services. This organization has a focus on new and innovative technologies and implementing the appropriate quality controls for the determined risk profiles.
As the Senior Manager of QMS Operations, you will have the unique opportunity to oversee the operations of the Johnson & Johnson's Technology Services QMS. This role will have a primary focus on the ownership, management and coordination of the quality metrics required for GxP decision making. Operational support may also be required for innovative analysis and oversight of QMS elements processes such as Quality Planning, CAPA, Document Management, Training Management, Supplier Management, SDLC/Validation, and Product and Non-product Security. Your role will be critical in ensuring that the QMS is flawless, world-class, and adheres to GxP requirements and ISO regulations while consistently implementing continuous enhancements.
Key Responsibilities
Responsible for delivery of the QMS metrics, reports, and dashboards in support of Quality Management Review, operational QMS meetings, and periodic updates as applicable.
Review and optimize key quality metrics to create opportunities for increased success and implementation of those changes.
Develops and reports on key quality metrics to drive continuous improvement and sustain technology systems’ compliance.
Provides QMS oversight and services for the J&J Technology Services (JJT-TS) quality elements as assigned by the Director of the QMS
Establishes and maintains quality assurance standards, which adhere to GxP practices, Quality System and ISO regulations. Responsible for communicating business related issues or opportunities to next management leve
Own and implement novel process improvement projects within the QMS elements to drive exceptional results, continuous improvement and sustain compliance.
Develop an analytics framework and lead projects as needed to sustain compliance
Supports & leads inspections including communication and coordination with J&J corporate organizations and Health Authorities when required
Provide an environment which encourages the company’s credo and the value of a diverse workforce
People Management
Identifies critical skills and capabilities required to ensure the development of a highly skilled, high performing QMS
Support the development of indirect reports including training and mentoring to meet current and future business needs
Works with Quality Operations leadership and pillar leaders to nurture future leaders and create opportunities to grow
Mentors talent and helps them grow in their careers
Qualifications
Leadership Competencies
Advanced leadership and relationship management skills
Strong cross-boundary collaboration, interdependent partnering, and influence skills
Able to inspire trust and quickly build credibility
Excellent listening skills and incorporates diverse points of view
Superior level of innovative thinking and trend spotting
Professional Competencies
Advanced problem-solving skills to assist in maintaining project progress and on design issues
Excellent intellect, strategic and big picture thinking ability, complemented by operational and business planning orientation
Outstanding executive presence, communication and facilitation skills
Advanced ability to team with others and drive towards a common goal
Sets clear performance standards and drives to results
Works effectively in a virtual team environment
Strong analytical and strategic skills with a bifocal approach - ability to zoom-in/zoom-out for strategic and tactical, high-level, and detailed
Experience with managing a financial plan, budget and quality plan
Experience and Skills:
Education:
A Bachelor’s or equivalent University degree is required with a focus in Computer Science, Engineering, Information Systems, Business Administration or other related field preferred. Advanced or Masters degree preferred.
Required:
8-10 years of progressive experience in the pharmaceutical/med device/biotech industry, with direct experience in Healthcare Technology activities
Strong experience in managing analytics and visualization tools/systems supporting such as Tableau, Alteryx, BI tools
Advanced proficiency in skills including Data Integrity, Testing, Quality Management Systems
Experience with management of Quality Management Systems elements
Experience in quality risk management
Strong understanding of Global and Regional GxP Regulations including FDA Quality Systems and ISO 13485
Preferred:
Working knowledge of Agile, PMO, SDLC, GAMP 5, and ITIL frameworks.
Experience with Six Sigma/Process Excellence tools, training and certification.
Certified Software Quality Engineer (CQSE)
Certified Quality Engineer (CQE)
Project Management Professional (PMP)
Other:
This position may require up to 10% domestic & international travel.
The anticipated base pay range for this position is $120,000- 207,000 USD$
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 of Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
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.
Primary Location NA-US-New Jersey-Raritan
Other Locations North America
Organization Johnson & Johnson Services Inc. (6090)
Travel Yes, 10 % of the Time
Job Function Quality Systems
Req ID: 2406215942W