Our pharmaceutical client is looking for a Quality Assurance Manager. This role will be responsible for GMP related activities, including but not limited to, vendor audits, QMS management, and managing controlled documents. Experience with large molecules is a requirement for this role. This role requires travel to external partner sites.
Key Responsibilities
- Travel onsite for client, vendor, and other external partners to conduct audits and ensure regulations and guidelines are followed
- Implement, oversee, manage, and train team members on QMS systems
- Lead the development, execution, review and approval process of deviations, investigations, CAPAs, change request, SOPs and other various controlled documents
- Perform batch record review, product release, validation, stability reports, inspections, and root cause analysis
- Other responsibilities as assigned
Requirements:
- BS in Chemistry, Chemical Sciences, Biochemistry or equivalent education and experience
- Minimum 5+ years of Quality Assurance biopharmaceutical experience in a GMP environment
- Must have experience working with large molecules, gene therapy experience a plus
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