Job Title: Manager QA Validation
The Manager QA Validation is responsible for the qualification of equipment, utilities, software, and validation of cleaning and sterilization processes in Regeneron's Raheen facility.
Key Responsibilities:
* Designing and developing policies for validation and ensuring that they are effectively administered and comply with regulatory requirements
* Leading all aspects of QA validation including reviewing and approving documents related to area functions such as Failure investigations, Change controls, Test Plan documentation, SOPs, Validation protocols, and summary reports
* Managing Validation Department personnel by developing validation work plans, establishing objectives, and assigning tasks
* Developing and managing validation budget, contracts, and schedules
* Presenting and defending validation data to FDA and other regulatory agencies
Requirements:
* Bachelor's degree in Engineering, Chemistry, or Life Sciences
* 7+ years of direct experience in validation of pharmaceutical or biopharmaceutical facilities and processes
* Minimum of 2 years direct people management experience
About Us:
Regeneron is an equal opportunity employer. We value diversity and inclusion and provide comprehensive benefits to our employees. If you are dedicated to quality improvement and have strong leadership and problem-solving skills, this role might be for you.