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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 experienceworking with Pharmaceutical Quality Control/Quality Assurance R403287
Salary Range: NA
Minimum Qualification
8 - 10 years

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