Manager, Quality Control Electronic Systems
About The Position
At OXB, our people are at the heart of everything we do. We’re on a mission to enable life-changing therapies to reach patients around the world—and we’re looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful. Following the expansion of our US footprint with the acquisition of a new commercial-scale viral vector facility in Durham, North Carolina we have some new opportunities to join us. We’re currently recruiting for an on-site Manager of Quality Control Electronic Systems to join our Quality team. You will provide strong guidance for the governance of lab automation and computerized systems, as well as defining Compliance for Data Integrity for electronic applications within the Quality Control labs, playing a key part in advancing our mission and making a real difference.
Requirements
- BS/BA in a relevant field preferred
- Knowledge of 21 CFR Part 11, Annex 11 regulations, GAMP 5 and GMPs
- Minimum of 5 years of relevant experience in a similar role
- Adept at managing systems for Compliance and inspections
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
- Superb organizational, analytical, and communications skills
Responsibilities
- Serve as SME for all QC electronic systems, including Data Integrity and interfacing with regulatory agencies during inspections
- Ensures QC electronic systems are compliant with applicable regulations and procedures
- Develops, authors and maintains the relevant site policies and procedures within the QMS for the QC electronic systems at OXB-Durham
- As a member of Quality, initiates/ owns and participates fully within Change Management, Investigations and Continuous Improvement activities for QC Electronic Systems at OXB-Durham
- Monitors system configuration and use account privileges to ensure Data Integrity and Compliance with regulations
- Partners with IT to enable system patches, updates and upgrades
- Sets up new lab equipment within the QC systems compliantly as per site procedures
- Provides day-to-day end user support for QC systems
- Represents QC on cross functional infrastructure projects to ensure QC electronic systems remain compliant
- Lead and support continuous improvement initiatives and CAPAs related to QC electronic and lab automation systems
- Provides training, customer support and troubleshooting of problems as needed
Benefits
- Competitive total reward packages
- Wellbeing programs that support your mental and physical health
- Career development opportunities to help you grow and thrive
- Supportive, inclusive, and collaborative culture
- State-of-the-art labs and manufacturing facilities
- A company that lives its values: Responsible, Responsive, Resilient, Respect
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What This Job Offers
Job Type
Full-time
Career Level
Manager
