Pharma QA Leader: Compliance, CAPA & Audits

ESTEVE; Morton Grove (IL); On-site; USD 120,000 - 180,000; Full time

Job summary

ESTEVE is seeking a senior Manager of Quality Assurance in the US to lead the SQE organization, ensuring that pharmaceutical manufacturing, testing, and distribution meet strict regulatory and quality standards. You will partner with T&D, Engineering, Operations, and external customers to support GxP systems across the product lifecycle.

The role requires 10+ years in pharma/biotech QA, extensive regulatory knowledge (FDA/EMA), and proven success in leading teams, conducting audits, and driving

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Engineering, or related field.
• 10+ years of QA experience in pharma/biotech, small-molecule/API preferred.
• Strong working knowledge of FDA, EMA, and other global regulatory standards.
• Experience in clinical development, manufacturing, and post-market activities.
• Demonstrated experience leading autonomous and collaborative teams in fast-paced settings.
• Experience developing, implementing, and maintaining a QMS in compliance with cGMP and ICH; audits experience.

Responsibilities

• Develop and implement quality policies, standards, and systems aligned with regulatory obligations
• Set measurable quality objectives and integrate quality into the plant’s culture
• Communicate the importance of quality to 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
• Investigate deviations, non-conformances, and CAPA 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 embed quality in all processes

Skills

Quality Assurance

Regulatory compliance

GxP systems

Audits

Vendor management

Education

Bachelor’s degree in Pharmacy, Chemistry, Biology, Engineering, or related field

10+ years pharma/biotech QA experience

Tools

QMS (cGMP)

CAPA systems

Job description

ESTEVE is seeking a senior Manager of Quality Assurance in the US to lead the SQE organization, ensuring that pharmaceutical manufacturing, testing, and distribution meet strict regulatory and quality standards. You will partner with T&D, Engineering, Operations, and external customers to support GxP systems across the product lifecycle.

The role requires 10+ years in pharma/biotech QA, extensive regulatory knowledge (FDA/EMA), and proven success in leading teams, conducting audits, and driving