SR Manager, Quality Management Systems Operations

J&J Family of Companies - SR Manager, Quality Management Systems Operations

SR Manager, Quality Management Systems Operations - 2406215942W

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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.

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 oversee the operations of Johnson & Johnson's Technology Services QMS. This role will 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.

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.
• Develop and report on key quality metrics to drive continuous improvement and sustain technology systems’ compliance.
• Provide QMS oversight and services for the J&J Technology Services (JJT-TS) quality elements as assigned by the Director of the QMS.
• Establish and maintain quality assurance standards, which adhere to GxP practices, Quality System and ISO regulations.
• 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.
• Support & lead 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

• Identify 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.
• Work with Quality Operations leadership and pillar leaders to nurture future leaders and create opportunities to grow.
• Mentor talent and help 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.
• 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 $120,000- 207,000 USD$.

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)

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