Job: Senior Manager Quality Control and Stability Operations, Tergus Pharma, Durham, NC
This position ensures compliance for Analytical, Stability Data and Data Review and documentation compliance with GMP regulations and internal procedures within a GMP analytical and manufacturing facility.
Summary of Key Responsibilities:
• Approval of QC analytical test methods, protocols and specifications;
• Management of the teams to ensure the workload is scheduled appropriately to meet customer Release testing schedules and stability pull dates and
• Ensure all data is reported through the appropriate channels of communication – Customer Certification of Analysis to external and
stability databases internally.
• Oversight for review of QC and Stability data for compliance with Customer Requirements and specifications and regulatory requirements • Managing, Develop, and Maintain a diverse professional staff of Analytical Scientists and Data Reviewers with responsibilities for in- process, finished
products, raw materials release, stability sample testing, analytical method development validation.
• Manage staff while promoting team collaboration and ensuring balance of workload and responsibility.
Required Qualifications and Skills:
• B.S. in a scientific discipline.
• 8+ years' experience in a Quality Assurance role in the pharmaceutical industry
• Must have at least 3 years of recent CMC regulatory experience.
• Experience in managing Analytical and Stability Teams
• Experience using SLIM software for collection and calculation of Stability data and trending.
• Experience in Data Review of Analytical data per GDP guidelines.
• Proven ability to review and evaluate the compliance and completeness of analytical data. • Thorough knowledge of GxP regulations
• Proven ability to collaborate with technical staff and customers
• Is thorough when performing work; conscientious about attention to detail; uses logical thinking that is well organized and methodical
• Able to multi-task productively, applying time management processes and procedures effectively
• Technically capable of determining what is wrong in complex situations and offering potential solutions, identifying root cause of a problem and working
with others to correct problems
• Works toward common goals by supporting, encouraging and sharing information with colleagues • Speaks, writes, listens and presents information in a logical and articulate manner
Tergus Pharma, LLC (the "Company") is proud to provide equal employment opportunities (EEO) to all individuals regardless of their race, color, creed, religion, gender identity, age, sexual orientation, national origin, disability, veteran status, genetic information, physical or mental disability, medical condition, or any other characteristic protected by state, federal or local law.