Quality Assurance Manager

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

The Manager of Quality Assurance is a critical contributor within Esteve’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.

Responsibilities

• Develop and implement quality policies, standards, and systems aligned with the organization’s mission and regulatory obligations
• Set measurable quality objectives and integrate quality into the plant’s 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

Requirements

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Engineering, or a related scientific/technical discipline
• 10+ years of progressive experience in pharmaceutical or biotech Quality Assurance, experience with small-molecule/API preferred
• Strong working knowledge of FDA, EMA, and other global regulatory standards
• Experience in both commercial and development phases of pharmaceutical products, including clinical development, manufacturing, and post-market activities
• Demonstrated experience in autonomous and collaborative team environments, with a track record of managing change in complex, fast-paced settings
• Ability to prepare for and manage internal and external audits (including investigator sites, CROs, and vendors)
• Experience developing, implementing, and maintaining a Quality Management System (QMS) in compliance with cGMP, ICH, and other standards
• Oversight of CAPA (Corrective and Preventive Action), deviation management, change control, and training systems
• Experience with risk management, design control, and supplier qualification audits
• Experience working in global organizations is a plus