SR Manager, Quality Management Systems Operations

$120,000 - $207,000/Yr

Johnson & Johnson - Columbia, SC

Full-time - Mid Level

Columbia, SC

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 GxP requirements and ISO regulations, and implementing continuous improvements within the QMS. The position also involves leading inspections, mentoring talent, and fostering a diverse workforce.

Responsibilities

• Deliver QMS metrics, reports, and dashboards for Quality Management Review and operational meetings.
• Review and optimize key quality metrics to enhance success and implement changes.
• Develop and report on key quality metrics to drive continuous improvement and compliance.
• Provide QMS oversight and services for assigned quality elements.
• Establish and maintain quality assurance standards adhering to GxP practices and ISO regulations.
• Implement process improvement projects within the QMS to drive results and sustain compliance.
• Develop an analytics framework and lead projects to maintain compliance.
• Support and lead inspections, coordinating with corporate organizations and Health Authorities as needed.
• Foster an environment that encourages the company's credo and values diversity.

Requirements

• Bachelor's degree in Computer Science, Engineering, Information Systems, Business Administration, or related field; advanced 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 such as Tableau, Alteryx, and BI tools.
• Advanced proficiency in Data Integrity, Testing, and Quality Management Systems.
• Experience managing 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 Washington residents.
• Holiday pay, including Floating Holidays - up to 13 days per calendar year.
• Work, Personal and Family Time - up to 40 hours per calendar year.