SR Manager, Quality Management Systems Operations

$120,000 - $207,000/Yr

Johnson & Johnson - Boston, MA

Full-time - Senior

Boston, MA

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 providing oversight for various quality elements and leading process improvement projects to enhance operational efficiency.

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 J&J Technology Services quality elements as assigned.
• Establish and maintain quality assurance standards adhering to GxP practices and ISO regulations.
• Implement novel process improvement projects within QMS elements 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 values diversity and the company's credo.

Requirements

• Bachelor's degree in Computer Science, Engineering, Information Systems, Business Administration, or related field; advanced degree preferred.
• 8-10 years of 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 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.