SR Manager, Quality Management Systems Operations

$120,000 - $207,000/Yr

Johnson & Johnson - Baton Rouge, LA

Full-time - Mid Level

Baton Rouge, LA

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 ISO regulations, and implementing continuous improvements within the QMS. The position requires strong leadership and collaboration skills to drive quality assurance standards and support the development of a high-performing team.

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; Advanced or Masters degree 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, 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; for employees in 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.