Manager QA Validation (Fill Finish)
Regeneron
Full-time
Remote friendly (East Greenbush, NY)
United States
Operations
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Role Summary
Manager QA Validation (Fill Finish) leads validation efforts for equipment, systems, and processes related to cleaning, sterilization, and aseptic process simulation validation in compliance with regulatory requirements and company standards.
Responsibilities
- Leads cross-functional teams in developing validation best practices, standards, and guidelines, exploring new techniques, methods, and industry practices.
- Leads projects by developing plans, schedules, and resource loading; executes validation projects and mentors junior staff; performs validation tasks including authoring protocols, implementing validation protocols, and writing validation reports.
- Reviews and approves validation protocols and summary reports; mentors staff in writing protocols and final reports.
- Prepares equipment for qualification studies and implements qualification and validation studies per approved protocols and SOPs.
- Leads a team of validation specialists to investigate and troubleshoot problems and determine solutions or improvements.
- Approves documents relating to area function; provides direction and assigns work to validation staff to meet goals and timings.
- Coordinates prioritization of activities with area management.
- Monitors compliance of area operations, including trend analysis of failures and evaluation of corrective actions.
- Reviews internal and external requirements and implements required processes to meet quality expectations.
- Participates in regulatory and customer activities; collaborates with functional departments to resolve issues.
- Leads projects and prepares status reports.
Qualifications
- Associate Manager: 6+ years; Manager: 7+ years (Bachelor’s degree in Chemistry, Engineering, or Life Sciences; may substitute proven experience for education).
Skills
- Strong leadership and project management skills.
- Ability to thrive in a quality-focused environment; proactive approach to drive projects/tasks to completion.
- Mentoring and people development capabilities.
Education
- Bachelor’s degree in Chemistry, Engineering, or Life Sciences (required).
Additional Requirements
- Gowning and cleanroom environment requirements detailing attire and safety precautions.
- Travel and regulatory activities as part of role (as applicable).