Principal Quality Engineer

3 weeks ago

St Louis MO USA, United States Mallinckrodt Pharmaceuticals Full time
Job Title

Principal Quality Engineer

Job Summary

Mallinckrodt Pharmaceuticals is seeking a highly skilled Principal Quality Engineer to join our team. As a key member of the Quality Systems organization, you will be responsible for managing the development, establishment, and maintenance of quality programs, including policies, processes, procedures, and controls.

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
  • Manage the process that develops, establishes, and maintains quality assurance programs, policies, process, 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
Requirements
  • BS/BS in 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
Skills/Competencies
  • Project management
  • Good computer skills, including proficiency with business and technical software (Work, Access, Excel, Powerpoint)
  • Ability to identify and drive continuous quality improvement
Other Skills
  • Ability to matrix manage projects with multiple functional groups without direct reporting authority
  • Strong communication and interpersonal skills
  • Getting work done through others that are not direct reports
  • Operates with minimal direction
  • Building relationships with other departments
  • Statistical Analysis capability
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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