Quality Assurance Manager at ESTEVE Quality Assurance Manager at ESTEVE in Wilmette, Illinois Posted in 13 days ago.

Type:

full-time 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