Job Information
J&J Family of Companies Director, Quality Management Systems in Raritan, New Jersey
Director, Quality Management Systems - 2406201489W
Description
Johnson & Johnson is recruiting for a Director of Quality Management Systems (QMS) Operations! This position can be located in 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 Director QMS Operations, you will have the unique opportunity to oversee the governance of two distinct quality management systems, Johnson & Johnson's Technology Services and Enterprise Quality QMS. This role includes providing innovative analysis and oversight of key QMS elements processes such as Non-Conformance, 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
Ownership of J&Js Technology Services and Enterprise Quality QMS, including establishing the framework and tactical execution of QMS elements for technical systems and data.
Provides direct QMS oversight and services for the following functions: Regulatory Operations, Environmental Health, Safety & Sustainability, Engineering & Property Services, Supply Chain Data Operations and Data Management, J&J Regulatory Compliance, JJ Microbiology Quality & Sterility Assurance, Transportation, Commercial Quality and Shared Services (CQSS), and Technology Services (JJT-TS)
Develops and reports on key quality metrics to drive continuous improvement and sustain technology systems compliance. Lead Quality Management Review with Senior Executives.
Review and optimize key quality metrics to determine opportunities for increased success and implementation of those changes.
Establishes and maintains quality assurance standards, which adhere to Good Manufacturing Practices, Quality System and ISO regulations. Responsible for communicating business related issues or opportunities to next management level
Understands and interprets regulatory requirements such as: National Regulatory agencies (FDA, MDA, etc.), Standards organizations (ISO, IEC, AAMI, ICH, etc.), Notified bodies (BSI, TUV, TNO, etc.) as applicable
Own and implement novel process improvement projects within the QMS elements to drive exceptional results and sustain compliance.
Establishes procedures and techniques for the control of quality standards; plan and coordinate with senior management in the development and improvement of Quality systems, policies, procedures and goals
Works with cross-functional & shared services teams to identify and eliminate compliance deficiencies and manages the Quality Systems function, personnel and the budget
Supports & leads inspections including communication and coordination with J&J corporate organizations and Health Authorities when required
Provide an environment which encourages the companys 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
Responsible for the development of direct/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
Qualifications
Education:
A Bachelors degree in Computer Science, Engineering, Information Systems, Business Administration or other related field required; advanced degree preferred; solid, relevant experience may be substituted when appropriate; additional certifications a plus
Required:
10-12 years of progressive experience in the pharmaceutical/med device/biotech industry, with direct experience in Healthcare Technology activities
Experience in defining and implementing quality programs along with Global teams across multiple geographies
Advanced mastery of skills including Quality Strategy, Data Integrity, Testing, Quality Management Systems
Experience with establishing and/or management of Quality Management Systems for technology and enterprise functions
Experience in quality risk management
Advanced 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.
Other:
- This position may require up to 25% domestic & international travel.
The anticipated base pay range for this position is $142,000-$244,950.
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 corporations performance over a calendar/performance year. Bonuses are awarded at the Companys 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 Companys consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Companys 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 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
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-Raritan
Other Locations NA-US-Pennsylvania-Horsham, NA-US-Massachusetts-Raynham, NA-US-New Jersey-New Brunswick
Organization Johnson & Johnson Services Inc. (6090)
Travel Yes, 25 % of the Time
Job Function Quality Systems
Req ID: 2406201489W