Quality Assurance Manager
Company Summary: An international CRO, specializing in small molecules and large molecule bioanalysis, is currently seeking a driven, motivated, and multi-faceted QA Manager. This role will be located in the greater Chicago area. The QA Manager will play a critical role in ensuring lab operations are in compliance with GLP requirements. The ideal candidate will have strong leadership skills, attention to detail, and a thorough understanding of GLP requirements.
The QA Manager will be responsible for:
- Developing and implementing a quality system to support bioanalytical lab operations.
- Serving as a company SME on GLP requirements from a quality assurance perspective.
- Leading and reporting inspections, data audits, quality systems audits, etc.
- Develop, review, and authorize documents necessary to maintain GLP compliance.
- Collaborate with management to stay informed about compliance challenges and communicate audit findings, facilitating necessary discussions.
- Manage the controlled document system to ensure accurate and up-to-date documentation.
- Oversee the quality aspects of sponsor visits and audits.
The QA Manager should have the following qualifications:
- Strong leadership/management qualifications
- Deep familiarity with quality assurance systems in a bioanalytical lab - experience with ICH M10 guidelines
- Strong understanding of regulatory requirements and quality standards applicable to pharmaceutical manufacturing (e.g., FDA regulations, GLP guidelines)
If you see yourself in this QA Manager role and are interested, then please don't wait to apply.
