Senior Manager of Quality Management Systems (QMS) Operations - Johnson and Johnson

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:

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

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.