Quality Assurance Manager

Manager of Quality Assurance

The Manager of Quality Assurance is a pivotal role within our SQE organization, ensuring that all pharmaceutical manufacturing, testing, and distribution processes adhere to stringent regulatory, safety, and quality standards. This position is vital in safeguarding patient safety, maintaining product efficacy, and ensuring compliance with laws such as U.S. FDA regulations and international standards. The role requires close collaboration 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, and suppliers.
• Lead 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.
• Collaborate with R&D, production, supply chain, and regulatory affairs to ensure quality is embedded in all processes.

Essential Skills

• 10+ years of progressive experience in pharmaceutical or biotech Quality Assurance, with a preference for experience with small-molecule/API.
• 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.

Additional Skills & Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, Engineering, or a related scientific/technical discipline.
• Experience working in global organizations is a plus.
• Strong attention to detail and ability to operate effectively in highly regulated environments.
• Excellent critical thinking and risk-based decision-making skills.
• 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.

Work Environment

The QA team consists of over six individuals, supporting the CDMO QC Lab and Production teams onsite at the Morton Grove production/lab/office facility. The work is conducted in an office environment located above the lab/production area.

Job Type & Location

This is a Permanent position based out of Morton Grove, IL.

Pay and Benefits

The pay range for this position is $120000.00 - $140000.00/yr. Health insurance, 401k, dental, vision, PTO, etc. 10% STI incentive bonus for this role.

Workplace Type

This is a fully onsite position in Morton Grove, IL.

Application Deadline

This position is anticipated to close on Aug 12, 2026.