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Senior Quality Manager

Morton Grove, IL 60053

Posted: 02/04/2026 Employment Type: Direct Hire Industry: Quality and Regulatory Affairs Job Number: 12526 Pay Rate: $135k - $142k Remote Friendly: Onsite

Job Description

Our client is a global API development and manufacturing company expanding end-to-end CDMO services in the U.S.


Roles and Responsibilities:
  • Lead and manage the Quality Assurance and Quality Control teams at the site, as well as working with Global Regulatory Affairs for RA topics.
  • Ensure compliance with GMP regulations, global quality standards, and customer requirements for API manufacturing.
  • Oversee batch release activities, including review and approval of clinical and commercial GMP batches.
  • Develop, implement, and maintain Quality Systems (deviations, CAPA, change control, investigations, audits, etc.) to ensure a state of continuous compliance and inspection readiness.
  • Act as the primary quality contact for clients, regulatory authorities, and internal stakeholders for the site.
  • Support regulatory inspections and client audits; ensure timely and effective closure of observations.
  • Collaborate closely with Operations, Engineering, Regulatory Affairs, and Project Management to support manufacturing and technology transfer activities.
  • Drive continuous improvement initiatives to enhance quality performance and operational efficiency.
  • Manage and develop the Quality team through effective leadership, training, and performance management.
  • Contribute to the site’s strategic planning as part of the site leadership team.

Job Profile:
  • Required Studies: Bachelor’s / master’s degree in chemistry, Pharmacy, Chemical Engineering, or related field.?

Job Requirements

Specialized Knowledge:
  • Proven experience in a CDMO environment, working with multiple customers and projects.
  • Strong experience with clinical GMP batch manufacturing and release.
  • Previous experience managing and developing teams.
  • In-depth knowledge of ICH guidelines, GMP regulations (e.g., EU GMP, US FDA), and regulatory expectations.
  • Excellent communication skills and ability to interact effectively with internal and external stakeholders.
  • Strong problem-solving and decision-making skills.

Professional Experience:
  • Minimum 5 years of experience in Quality roles within the pharmaceutical or chemical API industry.

Organization Chart and Job Relationships:
  • Line Manager: Global Quality Head
  • Matrix Manager: Site Head
  • Direct Reporting: 2 direct reports: QA Manager and QC Manager

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!