The Manager QA Validation is responsible for qualifying equipment, utilities, software, and validating cleaning and sterilization processes in Regeneron's Raheen facility.
A typical day might include:
* Designing and developing policies for validation and ensuring they are effectively administered and comply with regulatory requirements
* Leading all aspects of QA validation including reviewing and approving documents such as failure investigations, change controls, test plans, SOPs, validation protocols, and summary reports
* Managing Validation Department personnel by developing validation work plans, establishing objectives, and assigning tasks
* Developing and managing validation budgets, contracts, and schedules
* Presenting and defending validation data to FDA and other regulatory agencies
* Maintaining validation document and software control systems
* Ensuring validation status is maintained for equipment and software use in commercial and clinical manufacturing
* Organizing QA validation resources assigned to functional areas to meet goals and timings; coordinating and prioritizing activities with area management
* Playing a proactive role in developing and applying new approaches and processes to validation strategies
* Working with senior managers and executives to create a broad-based validation program
Requirements
* Strong leadership and problem-solving skills, with the ability to empower and lead a team
* Dedication to quality improvement and the ability to handle pressure professionally
* Strong oral and written communication skills, with a focus on collaboration and stakeholder engagement
* Solid understanding of Data Integrity
* Strong understanding and application of GMP and regulatory requirements
To be considered for this position, you must hold a BS/BA in Engineering, Chemistry, or Life Sciences with 7+ years of direct experience in validation of pharmaceutical or biopharmaceutical facilities and processes. You must also have a minimum of 2 years direct people management experience.