Senior Quality Assurance Manager

1 week ago

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

Senior Quality Assurance Manager


Job Description Summary


Job Description


The Senior Quality Assurance Manager will be responsible for managing the development, establishment, and maintenance of quality programs, including policies, processes, procedures, and controls. This includes ensuring that performance and quality of cGXP documentation conform to established standards and requirements.


The incumbent will work with colleagues within Quality Operations to ensure that these quality systems are maintained and managed in full GXP compliance. The incumbent will be relied upon for sustained success for future strategic initiatives.


The Senior Quality Assurance Manager will report to the Executive Director, Quality. The position will lead improvement efforts to ensure alignment and compliance with all applicable regulations and internal 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
  • 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
  • Interact with corporate support groups to drive quality programs
  • Serve as cGXP compliance subject matter expert

Requirements:


  • BS/BS in related field
  • 10-15 yrs 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 who needs 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

Additional Information:


Mallinckrodt provides equal employment opportunities to applicants and employees without regard to race, color, gender, gender identity, sexual orientation, religions practices and observances, national origin, pregnancy, childbirth, or related medical conditions, protected veteran status, disability, or any other category protected by law.


Mallinckrodt Pharmaceuticals is an equal opportunity employer and welcomes applications from diverse candidates.

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