Product Quality Senior Manager

📋 Description

• Maintains the primary quality lead with management oversight for project activities and the team
• Participates in the development of global Product Quality Assurance strategy to support
• Performs final quality release of manufactured product lots for products and/or product lines
• Makes recommendations for key decisions on product quality and compliance and regulatory
• Establishes and maintains relationships and open communication with Third Party Manufacturers
• Communicates and negotiates with external companies’ quality organization to maintain a consistent

🎯 Requirements

• Bachelor’s Degree in relevant Life Science, Engineering, or other technical discipline required.
• Total combined years of experience. Minimum 8+ years. At least 3 years in Quality Assurance
• Knowledge and a comprehensive understanding/expertise of some biological and/or pharmaceutical
• Strong quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or
• Experience with FDA and other regulatory agency interactions and inspections is required.
• Familiarity with the requirements for third party external manufacturing.

🎁 Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick)
• This job is eligible to participate in our long-term incentive programs.