J&J Family of Companies Senior Manager of Quality Management Systems (QMS) Operations Honolulu , Hawaii Apply Now
Senior Manager of Quality Management Systems (QMS) Operations - 2406218653W
Be one of the first applicants, read the complete overview of the role below, then send your application for consideration.
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 system elements within the Technology Services QMS required for GxP decision making.
Operational support will be required for innovative oversight of QMS elements processes such as Quality Planning, CAPA, Non-conformance, Escalation, Data Management, Change Control, Purchasing Controls, 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
Provides QMS oversight and execution 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.
Develops and reports on key quality metrics to drive continuous improvement and sustain technology systems’ 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 :
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
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
Qualifications
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
Advanced proficiency in skills including Data Integrity, Testing, Quality Management Systems
Experience with management of Quality Management Systems elements with preference for Non-Conformance and CAPA
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)
J-18808-Ljbffr
Senior Manager of Quality Management Systems (QMS) Operations
J&J Family of Companies Senior Manager of Quality Management Systems (QMS) Operations Honolulu , Hawaii Apply Now. Senior Manager of Quality Management Systems (QMS) Operations - 2406218653W. Johnson & Johnson is recruiting for a Senior Manager of Quality Management Systems (QMS) Operations!...
Cash Management Product Manager
Under the direction of the Manager, the Cash Management (CM) Product Manager I is responsible for assisting in and/or actively managing a line of cash management products and services by ensuring that short and long term plans and objectives are successfully met. Maximise your chances of a successfu...
Site Management Operations Manager Full-time
As the Site Management Operations Manager, you will support the Director of Site Management in overseeing site management accounts. Job Title: Site Management Operations Manager. Assist director of site management with interviewing and onboarding of new employees. Your responsibilities include devel...
Center Operations Manager
Lead the planning, quality, and delivery of programs on and off of U. The Center Operations Manager position is responsible for overseeing one or more USO Center’s operations, and overseeing programs, events and activities at locations surrounding the Center(s). Our team is comprised of dedicated pr...
Senior Manager, Cyber Defense
As a senior manager of Cyber Defense reporting to the Fellow, Cyber Defense, you will have a unique opportunity to help evolve, implement, and operationalize the future of defense at Johnson & Johnson. J&J Family of Companies - Senior Manager, Cyber Defense - Honolulu, Hawaii. Through our ex...
Senior Manager, Event Management
Reporting into the Regional Director, the Senior Manager, Event Management is an event specialist and local market expert who oversees the pre to post event responsibilities, from planning and preparation to execution and reporting. Founded in 1901 in Tokyo, Japan, and now present in more than 110 m...
Senior Program Manager
Bachelor of Science (BS) in Business Management or related field plus seven (7) years of experience in project and program management, or an appropriate combination of education and experience in project and program management functions. Manages various DoD and other Federal projects within assigned...
Senior Project Manager - Glass Family of Companies
Our client has been in business since 1944 and have a large labor force of skilled craftsman with a full support staff of professionals who comprise of engineering, project management, QA, EHS, accounting, contracts, and human resources. Must be knowledgeable of Project Management principles such as...
Auxiliary Services Officer (Assistant Operations & Maintenance Manager)
Possession of a baccalaureate degree in Business Administration, Project Management or Facilities Management or related field and three (3) years of progressively responsible professional experience with responsibilities for Facilities Management Operations OR Project Management; or any equivalent c...
Senior Manager of Internal Audit
Independently execute full spectrum of the audit cycle including planning, fieldwork and reporting on audit projects including operational and financial business process audits, as well as IT audits including but not limited to the evaluation of the system and network infrastructures, physical and l...