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Quality Assurance Manager

Morton Grove, IL 60053

Posted: 07/06/2026 Employment Type: Direct Hire Industry: Quality and Regulatory Affairs Job Number: 12687 Pay Rate: $100k - $130k Remote Friendly: Onsite

Job Description

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

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

Job Requirements

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
  • 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

Meet Your Recruiter

Lexie Pierce
Senior Recruiter

As a Compass recruiter, Lexie brings in 15 years of experience in leadership and employee growth and development. She's incredibly passionate about helping candidates find and accept new opportunities, ultimately leading her to start her recruiting career in the life science industry. Her favorite part about connecting with Compass candidates and clients is witnessing the excitement the candidates exude and making an impact on their lives.

 

Outside of the office, Lexie enjoys going to the farmers' market on Saturdays with her son so she can find the best produce to use in her family dinners. She enjoys cooking, reading, knitting, restoring furniture, and spending time with her family and friends. Lexie is also passionate about supporting organizations that are looking to educate the community about Congenital Heart Defects (CHD).

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About Morton Grove, IL

Discover exciting job opportunities in and around Morton Grove, Illinois! Nestled in Cook County, this vibrant area offers a perfect blend of suburban charm and urban convenience. With easy access to nearby Chicago, Morton Grove provides a wealth of growth opportunities in diverse industries. Imagine working near the breathtaking Galloping Ghost Arcade, engaging with the local arts scene at Gallery Park, or enjoying delicious deep-dish pizza at Giordano's. From cheering on the Chicago Cubs at Wrigley Field to exploring the Morton Grove Prairie Nature Preserve, this region boasts a unique culture and endless possibilities for personal and professional growth. Explore our job listings today and take the first step towards an exciting career in Morton Grove!