About the Role
This position is responsible for leading quality assurance operations during the night shift, ensuring that all drug substance manufacturing processes adhere to current good manufacturing practices, regulatory requirements, and company standards. The manager will oversee batch record review, deviation management, and quality oversight of production activities.
Responsibilities
- Lead quality assurance functions during the night shift hours
- Ensure compliance with cGMP regulations in manufacturing operations
- Oversee real-time review of batch production records
- Manage quality investigations for deviations occurring during production
- Support timely batch disposition decisions
- Collaborate with manufacturing and technical teams on process improvements
- Ensure proper documentation practices are followed
- Review and approve critical manufacturing documentation
- Escalate quality issues to senior management when necessary
- Monitor key quality performance metrics
- Participate in internal and external audits
- Ensure adherence to safety protocols in production areas
- Support validation activities for manufacturing processes
- Train production staff on quality requirements
- Maintain oversight of change control processes
- Ensure timely closure of quality-related actions
- Support regulatory inspection readiness efforts
- Coordinate with QA specialists and analysts
- Promote a culture of quality and compliance
- Respond to urgent quality issues during off-hours
Compensation
Competitive salary and benefits package
Work Arrangement
Full-time, night shift position
Team
Part of the Quality Assurance team within a global biopharmaceutical manufacturing environment
Why This Role Matters
This position plays a critical role in ensuring that all drug substance batches meet quality standards before release, directly impacting patient safety and regulatory compliance.
What We Offer
Opportunities for professional growth, a collaborative work culture, and the chance to contribute to life-changing therapies through high-impact quality oversight.
Not available for this position
