Manager, Quality Systems and Compliance


Dayton, OH


Manager, Quality Systems and Compliance

This position supports the Quality Systems and Compliance area providing oversight for the overall Pharmaceutical Quality System. The role will require knowledge of quality systems to enable use of statistical methods to trend, diagnose and correct deficient quality practices. As part of oversight for the entire product life cycle, the position requires understanding of the principles of performance evaluation and prediction to improve product/systems reliability, apply technologies, failure analysis, design and manage performance improvement.

Key Duties:

  • Manages programs which drive higher levels of Quality Culture maturity and Excellence in Quality
  • Identify and implement quality process improvements as part of Quality Systems oversight for complaints, change controls, Annual Product Reviews, Risk Management, compliance, etc.
  • Collaborate with QC, MSAT, Manufacturing and Validation to monitor performance indicators to ensure the health of Product Quality
  • Act as backup facilitator for the Quality Review Board (QRB) and support high profile investigations
  • This position works a hybrid work from home and at site schedule to meet the business needs and may travel a few times per year

Preferred Skills/ Abilities:

  • Experience and knowledgeable with Statistical process control (SPC), and the application of SPC in trending of product performance
  • Knowledge of statistics, Six Sigma principles and tools, Lean enterprise concepts, Quality by Design (QbD) concept
  • Process validation lifecycle, data integrity and risk management knowledge
  • Team Player committed to quality; motivated self-starter; detail and results oriented; organized, efficient worker with good communication skills; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks
  • Can get things done based on influence
  • Comfortable workings in a fast-paced environment with multiple issues open simultaneously
  • Customer service mindset
  • Identifies opportunities to improve and contributes to problem solving
  • Experience designing, implementing, delivering and measuring effectiveness of improvements in a GxP environment
  • Understanding of the current pharmaceutical industry and applicable domestic and international compliance regulations
  • Full understanding of FDA regulations and best practices in GMP environment
  • Experience with root cause analysis, risk management, meeting management and excellent documentation skills

Required Education/Experience:

  • Bachelor’s degree in a scientific discipline or equivalent
  • 7-10+ years’ experience in the pharmaceutical industry, preferably with parenteral and oral dosage forms in a Quality role
  • Supervisory experience
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