Avalo Therapeutics
Sr. Manager, Quality Assurance
Chesterbrook, PA · Senior
Sponsorship not specifiedDetected 21 days ago
Data AnalysisHRFDA RegulatoryCommunicationCollaborationGxP
About the role
- Serve as the system owner and administrator for Veeva QMS.
- Ensure system configuration aligns with company needs and regulatory expectations.
- Monitor and report training compliance metrics to the team and management.
Responsibilities
- Manage user access, workflows, and periodic system updates.
- Document Control & Compliance:
- Oversee document lifecycle management including creation, revision, approval, and archival.
- Support staff in following SOPs and Work Instructions during document revisions.
- Provide guidance and hands-on assistance with document drafting and formatting.
Requirements
- Bachelor's degree in Life Sciences, Engineering, or related field.
- Minimum 7 years of experience in QA within the biotech or pharmaceutical industry.
- Proven experience managing electronic QMS platforms, preferably Veeva.
- Strong understanding of GxP regulations and CSV principles.
Skills
- Experience in a small or startup biotech environment.
- Knowledge of data analytics tools for tracking QA metrics.
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This listing is sourced directly from Avalo Therapeutics's careers page and normalized into a canonical job model.