Manager QA Validation

We are currently looking to add a Manager QA Validation (Oversight) to our growing team. This position is responsible for the management of the QA Validation Review teams for internal drug product facilities at Regeneron IOPS (Industrial Operations and Product Supply), providing quality oversight and management support to validation activities for IOPS.

In this role, a typical day might include the following:

- Overseeing QA Validation team supporting drug product operations, with a focus on mentoring and developing the team
- Engaging cross-functionally to define and support validation review activities, including guidance and review of validation deviations.
- Collaborating with QA Validation operations at each site to ensure critical validation activities are completed on time and with the highest degree of quality.
- Reviewing and providing quality oversight of the outcomes of validation activities, including, but not limited to: Shipping, Equipment, Computerized Systems, QC and methods, and process.
- Engaging with other QA leaders to ensure robust and consistent, quality-driven processes are developed to support a global IOPS organization.
- Providing leadership and tactical support for regulatory, partner and internal audits.
- Minimal travel may be required.

This role might be for you if you:

- Are excited to work in a start-up environment
- Have validation experience in a GMP environment; drug product validation experience preferred but not required
- Build and maintain strong working relationships across the business and with external partners, while providing exceptional customer service
- Have a continuous improvement mentality to identify and implement improvement opportunities
- Are flexible to working outside of core business hours, as needed

To be considered for this role you must hold a Bachelor’s degree in Engineering, Chemistry, or Life Sciences with a minimum of 7 years of overall experience; 4+ years’ experience in validation within biotech and/or pharma industry required.

LI-Onsite

REGNQA
Salary Range (annually)

$101,800.00 - $166,000.00