Stability Program Manager

Job Description

Essential Duties & Responsibilities:

  • Serve as the central point of contact for all product stability program activities in the site
  • Coordinate all stability program activities in the site
  • Develop and maintain a detailed understanding of all government regulations regarding all aspects of stability testing
  • Develop and maintain a detailed understanding of all corporate policies and procedures regarding stability testing
  • Aid in regulatory audits on all matters relating to product stability
  • Draft and maintain stability program policies and procedures as necessary to maintain compliance
  • Help establish and monitor stability related Quality Assurance programs and procedures to ensure compliance
  • Advise management on any corrective action required to maintain regulatory compliance with stability regulations and guidelines
  • Ensure the performance of periodic review of stability program
  • Develop goals for direct reports and provide training

Education & Special Training:

  • B. S./ B. A. in chemistry or a related technical field is required, an advanced degree is preferred.
  • In-depth knowledge in a broad range of analytical instrumentation is required
  • In-depth knowledge in pharmaceutical stability testing is required

Qualifications & Experience:

  • 8+ Years relevant experience with B. S./B. A.
  • 4+ Years relevant experience with M. S.
  • Proven experience in quality management and improvement
  • In depth understanding of quality control stability procedures and relevant legal standards
  • Excellent math abilities and working knowledge of data analysis/statistical methods
  • Excellent organizational and leadership skills
  • 5 to 10 years business experience working with Pharmaceutical Quality Control/Quality Assurance

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