SR Manager, Quality Management Systems Operations

$120,000 - $207,000/Yr

Johnson & Johnson - Columbus, OH

Full-time - Senior

Columbus, OH

Chemical Manufacturing

About the position

The Senior Manager of Quality Management Systems (QMS) Operations at Johnson & Johnson is responsible for overseeing the operations of the Technology Services QMS. This role focuses on managing quality metrics for GxP decision-making, ensuring compliance with quality standards, and implementing continuous improvements within the QMS. The position requires collaboration across various teams to maintain high standards of quality and compliance in healthcare technology activities.

Responsibilities

• Responsible for delivery of the QMS metrics, reports, and dashboards in support of Quality Management Review and operational QMS meetings.
• Review and optimize key quality metrics to create opportunities for increased success and implementation of those changes.
• Develops and reports on key quality metrics to drive continuous improvement and sustain technology systems' compliance.
• Provides QMS oversight and services for the J&J Technology Services quality elements as assigned by the Director of the QMS.
• Establishes and maintains quality assurance standards, adhering to GxP practices, Quality System, and ISO regulations.
• Own and implement novel process improvement projects within the QMS elements to drive exceptional results and sustain compliance.
• Develop an analytics framework and lead projects as needed to sustain 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.
• Identifies critical skills and capabilities required to ensure the development of a highly skilled, high performing QMS team.
• Support the development of indirect reports including training and mentoring to meet current and future business needs.

Requirements

• A Bachelor's or equivalent University degree in Computer Science, Engineering, Information Systems, Business Administration or related field is required; an advanced or Master's degree is preferred.
• 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 such as Tableau, Alteryx, and BI tools.
• Advanced proficiency in Data Integrity, Testing, and Quality Management Systems.
• Experience with management of Quality Management Systems elements and quality risk management.
• Strong understanding of Global and Regional GxP Regulations including FDA Quality Systems and ISO 13485.

Nice-to-haves

• 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).

Benefits

• Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• 401(k) retirement plan and savings plan.
• Vacation - up to 120 hours per calendar year.
• Sick time - up to 40 hours per calendar year; up to 56 hours for employees in Washington.
• Holiday pay, including Floating Holidays - up to 13 days per calendar year.
• Work, Personal and Family Time - up to 40 hours per calendar year.