QA Manager, Pharma/API Quality & Compliance

Compass Consulting; Morton Grove (IL); On-site; USD 150,000 - 230,000; Full time

Job summary

Compass Consulting represents a global biopharmaceutical client in the greater Chicago area seeking a Manager of Quality Assurance. This leader drives SQE activities to ensure CGMP compliance across manufacturing, testing, and distribution, partnering with R&D, operations, and regulatory affairs to embed quality in all processes.

The role emphasizes audit readiness, CAPA governance, supplier qualification, and continuous improvement within a highly regulated environment.

Qualifications

• 10+ years of progressive experience in pharmaceutical/biotech QA.
• Strong knowledge of FDA, EMA, and global regulatory standards.
• Experience in both commercial and development phases of pharma products.
• Proven ability to lead in regulated, fast-paced environments.
• Experience with QMS in line with cGMP and ICH.
• CAPA, deviation management, change control, and training systems.
• Risk management and supplier qualification audits.
• Global organization experience is a plus.
• Excellent communication and stakeholder management.
• Detail-oriented with a proactive, solution-driven mindset.

Responsibilities

• Develop and implement quality policies and systems aligned with regs.
• Set measurable quality objectives and embed quality into culture.
• Communicate quality importance to stakeholders and regulators.
• Supervise QA team including hiring and performance reviews.
• Oversee inspections and internal/external audits.
• Investigate deviations and CAPA processes.
• Monitor supplier quality and manage vendor contracts.
• Lead process improvements for quality and compliance.
• Maintain QMS and quality metrics reporting.
• Collaborate with R&D, production, regulatory to embed quality.

Skills

Regulatory knowledge

Quality Assurance

Audit management

QMS / cGMP

CAPA management

Risk management

Supplier qualification

Cross-functional

Change control

Documentation

GxP familiarity

Education

Bachelor's degree

Job description

Compass Consulting represents a global biopharmaceutical client in the greater Chicago area seeking a Manager of Quality Assurance. This leader drives SQE activities to ensure CGMP compliance across manufacturing, testing, and distribution, partnering with R&D, operations, and regulatory affairs to embed quality in all processes.

The role emphasizes audit readiness, CAPA governance, supplier qualification, and continuous improvement within a highly regulated environment.