Manager, Development Quality Assurance

Responsibilities

• Provide quality input for the development of Cogent’s early-stage candidates
• Quality review of master and executed batch records for the manufacture and packaging of drug substance and drug products
• Coordinate and participate in quality investigations (including OOS/OOT investigations, manufacturing deviations, etc). Work alongside impacted functions in the development of required CAPA items
• Oversee/Coordinate quality tasks at drug substance and drug product CDMOs
• Work with Analytical Development in the creation of analytical methods for early-stage candidates
• Assess CDMOs from a QA perspective for the manufacture, testing, and development of early-stage candidates
• Oversee and review stability program - protocol review, stability pull points, and final report review
• Provide QA support during manufacturing and analytical operations
• Support Risk Assessment initiatives in close collaboration with internal and external interfaces
• Support CMC, analytical, logistics, and regulatory functions as needed
• 15-20% of the job will require traveling

Qualifications

• Bachelor’s Degree in Science (required); Preferably in Pharmaceutical Sciences or Technology, Chemical Engineering, etc.
• Minimum of 5-7 years of relevant experience in a pharmaceutical quality assurance/control environment
• Experience overseeing the quality activities for the manufacture and development of early small molecule products
• Self-motivated and demonstrated success in working with cross-functional teams
• Must be detail oriented with proven abilities to meet deadlines
• Excellent interpersonal, written, and verbal communication skills