DIRECTOR, QUALITY MANAGEMENT SYSTEMS

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.
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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&J’s 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 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 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 ducation.
A Bachelor’s 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.
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 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.
This positon has an estimated annual salary of USD$ 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.
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