Quality Assurance Manager

Our client is a global biopharmaceutical company with an Active Pharmaceutical Ingredient (API) development and manufacturing facility in the greater Chicago area.

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Main Role:

The Manager of Quality Assurance is a critical contributor within our client'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.

Key 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

Required Studies:

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

Required Experience & Skills:

• 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
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• 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

Key Competencies:

• Strong attention to detail and ability to operate effectively in highly regulated environments
• Excellent critical thinking and risk-based decision-making skills
• Demonstrated ability to work as a trusted SME and advisor
• Proactive, self-driven, and solution-oriented mindset
• Strong collaboration and stakeholder management skills
• Excellent written and verbal communication skills, with the ability to translate complex compliance concepts for both technical and non-technical audiences
• Continuous improvement mindset with the ability to add value beyond basic compliance