Quality Assurance Manager

Compass Consulting

Morton Grove, IL

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JOB DETAILS

SKILLS

Active Pharmaceutical Ingredient (API), Contract Management, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Critical Care, Drug Manufacturing, Embedded Systems, External Audit, FDA Requirements, GxP, Internal Audit, Maintain Compliance, Manufacturing, Patient Safety, Performance Analysis, Performance Reviews, Policy Implementation, Process Improvement, Product Safety, Quality Assurance, Quality Assurance Methodology, Quality Management, Quality Metrics, Quality Monitoring, Regulations, Regulatory Compliance, Research & Development (R&D), Safety Standards, Software Testing, Supply Chain, System Lifecycle, Team Lead/Manager, Vendor/Supplier Management

LOCATION

Morton Grove, IL

POSTED

30+ days ago

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

Quality Assurance Manager

Compass Consulting

Morton Grove, IL

About the Company

Compass Consulting

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