Quality Assurance Manager

ESTEVE; Morton Grove (IL); On-site; USD 120,000 - 170,000; Full time

Job summary

Esteve is seeking a Manager of Quality Assurance to lead the QA function within its SQE organization in Illinois. You will ensure compliance with FDA, EMA, and global standards across manufacturing, testing, and distribution, protecting patient safety and product quality.

You will collaborate with T&D, Engineering, Operations, and external partners to maintain a robust QMS, drive CAPA, audits, and continuous improvement in a fast-paced, regulated environment.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Engineering, or related field.
• 10+ years in pharmaceutical/biotech QA with small-molecule/API experience preferred.
• Strong knowledge of FDA/EMA global regulatory standards.
• Experience across commercial and development phases, including audits.
• Experience in QMS, CAPA, deviation management, change control, and training systems.

Responsibilities

• Develop and implement quality policies, standards and systems.
• Set measurable quality objectives and embed quality in culture.
• Communicate quality importance to stakeholders including regulators.
• Supervise QA team including hiring, training and evaluations.
• Oversee inspections and respond to audits (internal and external).
• Investigate deviations, non-conformances, and CAPA processes.
• Monitor supplier quality and manage vendor contracts.
• Lead initiatives to improve process efficiency and compliance.
• Maintain and update the QMS and quality metrics reporting.
• Collaborate with R&D, production, supply chain and regulatory affairs.

Skills

Quality Assurance

CAPA

QMS

Audits

Regulatory knowledge

Education

Bachelor's degree in Pharmacy, Chemistry, Biology, Engineering, or a related scientific/technical discipline

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