Senior Quality Assurance Manager

6 days ago

Webster Groves, Missouri, United States Mallinckrodt Full time
Job Title

Principal Quality Engineer

Job Summary

We are seeking a highly skilled Principal Quality Engineer to join our Quality Systems organization. The successful candidate will be responsible for managing the development, establishment, and maintenance of quality programs, including policies, processes, procedures, and controls. This role will ensure that performance and quality of cGXP documentation conform to established standards and requirements.

Key Responsibilities
  • Manage the self-inspection program
  • Manage the supplier quality program
  • Provide backup technical support to the TrackWise System administrator
  • Conduct user training and support TrackWise system testing and upgrades
  • Develop, establish, and maintain quality assurance programs, policies, processes, procedures, and controls
  • Identify, develop, and execute quality plans and project timelines to meet group, site, and company goals
  • Participate in compliance audits and respond to audit observations
  • Support with FDA and other regulatory agencies investigations, inspections, and inquiries as needed
  • Interact with corporate support groups to drive quality programs
  • Serve as cGXP compliance subject matter expert
Requirements
  • BS/BS in a related field
  • 10-15 years of experience in manufacturing and control of pharmaceutical manufacturing and/or Quality with extensive FDA and global regulatory experience
  • Thorough knowledge of cGMPs/cGXPs pharmaceutical requirements
  • Proficient at technical and compliance understanding of quality processes associated with quality, CAPA, deviations/exceptions, root cause analysis, change control, and quality concepts in a distribution center/commercial office environment
  • Independent with little guidance or follow-up once projects/tasks are assigned
  • Proficient at multi-tasking, well-organized, and reliable for consistent decision-making and follow-through
  • Demonstrated auditing and corrective action proficiency
  • Demonstrated record of successfully assessing and determining the impact of current and potential regulatory compliance issues
  • Demonstrated proficiency of root cause analysis as applied in a pharmaceutical manufacturing environment
  • Excellent problem-solving and decision-making skills
  • Ability to manage and drive change
  • Computer skills
  • Knowledge of document management/quality systems
  • Direct experience with Regulatory inspection highly preferred
Organizational Relationships/Scope

Reports to Executive Director, Quality

Two or more direct reports

Frequent communication and working relationships with Business unit Management and Plant Management

Working Conditions

Employee will work in a normal office environment

Occasional travel (less than 20%)

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