Senior Operations QA Clinical GLP Manager

The Senior Operations QA Clinical GLP Manager is responsible for assisting in the development, implementation, and maintenance of end-to-end QA processes and activities, including GLP operations, and representing QA as the QA Partner (Primary Point of Contact) for Exelixis business stakeholders.

Requirements

• Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 9 years of related experience
• Master’s degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 7 years of related experience
• PhD in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 2 years of related experience
• Equivalent combination of education and experience
• A minimum of 8 years of related QA experience or the equivalent combination of experience and education/training
• Experience in the biotech or pharmaceutical industry, and clinical packaging/labeling activities is preferred
• Two years’ experience managing Contract Manufacturing Organizations preferred
• Five years general experience in biotech/pharmaceutical industry
• Experience in development of metrics and continuous improvements is preferred

Benefits

• 401k plan with generous company contributions
• Group medical, dental and vision coverage
• Life and disability insurance
• Flexible spending accounts
• Discretionary annual bonus program
• Sales-based incentive plan
• Opportunity to purchase company stock
• Long-term incentives
• 15 accrued vacation days in the first year
• 17 paid holidays including a company-wide winter shutdown in December
• Up to 10 sick days throughout the calendar year