Our client is a global biopharmaceutical company with an Active Pharmaceutical Ingredient (API) development and manufacturing facility in the greater Chicago area.
Main Role:
The Manager of Quality Assurance is a critical contributor within our client's SQE organization, responsible for ensuring that all pharmaceutical manufacturing, testing, and distribution processes meet strict regulatory, safety, and quality standards. This role is critical to protecting patient safety, maintaining product efficacy, and ensuring compliance with laws such as the U.S. FDA regulations and international regulations and standards. This role partners closely with T&D, Engineering, Operations, and external customers and vendors to support the full lifecycle of GxP systems.
Key Responsibilities:
Develop and implement quality policies, standards, and systems aligned with the organizations mission and regulatory obligations
Set measurable quality objectives and integrate quality into the plants culture
Communicate the importance of quality to all stakeholders, including management, employees, suppliers, and regulators
Supervise the QA team, including hiring, training, and performance evaluation
Oversee inspection preparations and respond to internal and external audits
Conduct investigations into deviations, non-conformances, and CAPA (Corrective and Preventive Action) processes
Monitor supplier quality and manage vendor contracts
Lead initiatives to improve process efficiency, product quality, and compliance
Maintain and update the quality management system and quality metrics reporting
Work with R&D, production, supply chain, and regulatory affairs to ensure quality is embedded in all processes
Numbers & Facts
Location
Morton Grove, IL
Skills
Active Pharmaceutical Ingredient (API)unmatched
Contract Managementunmatched
Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Critical Careunmatched
Drug Manufacturingunmatched
Embedded Systemsunmatched
External Auditunmatched
FDA Requirementsunmatched
GxPunmatched
Internal Auditunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Patient Safetyunmatched
Performance Analysisunmatched
Performance Reviewsunmatched
Policy Implementationunmatched
Process Improvementunmatched
Product Safetyunmatched
Quality Assuranceunmatched
Quality Assurance Methodologyunmatched
Quality Managementunmatched
Quality Metricsunmatched
Quality Monitoringunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Research & Development (R&D)unmatched
Safety Standardsunmatched
Software Testingunmatched
Supply Chainunmatched
System Lifecycleunmatched
Team Lead/Managerunmatched
Vendor/Supplier Managementunmatched
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