Quality Manager

Katalyst CRO; Chicago (IL); On-site; USD 95,000 - 130,000; Full time

Job summary

Katalyst CRO in Chicago is seeking an experienced Quality Manager to enhance Quality Assurance and Control activities. You will oversee quality systems, ensure compliance with relevant regulatory standards, and lead initiatives for continuous improvement in a regulated environment.

The ideal candidate will have substantial experience in Quality Assurance within pharmaceuticals or life sciences, alongside a Bachelor's or Master's degree in a related field. You will manage audits and lead cross-functional teams to uphold quality standards.

Qualifications

• 8-15 years of Quality Assurance and/or Quality Control experience in a regulated industry.
• Previous experience in a leadership or management role.
• Strong understanding of Quality Management Systems and regulatory compliance.

Responsibilities

• Lead and manage the organization's Quality Management System (QMS).
• Ensure compliance with FDA, cGMP, ISO 9001, ISO 13485 regulations.
• Oversee Quality Assurance (QA) and Quality Control (QC) operations.
• Drive continuous improvement initiatives using Lean, Six Sigma methodologies.
• Collaborate with Manufacturing, Engineering, Validation, Regulatory Affairs, R&D, and Supply Chain teams.

Skills

Quality Management System (QMS)

Regulatory compliance

Lean methodologies

Six Sigma

Root cause analysis

Education

Bachelor's or Master's degree in Pharmacy, Biotechnology, Chemistry, Microbiology, Life Sciences, Engineering, or a related field

Job description

We are seeking an experienced Quality Manager to lead Quality Assurance and Quality Control activities within a regulated pharmaceutical, biotechnology, medical device, or life sciences environment. The ideal candidate will oversee quality systems, ensure compliance with global regulatory standards, drive continuous improvement initiatives, manage audits, and lead cross‑functional teams to maintain product quality and regulatory compliance.

Responsibilities

• Lead and manage the organization's Quality Management System (QMS).
• Ensure compliance with FDA, cGMP, ISO 9001, ISO 13485, ICH, and applicable regulatory requirements.
• Oversee Quality Assurance (QA) and Quality Control (QC) operations.
• Develop, review, and approve SOPs, quality procedures, and controlled documents.
• Manage deviations, investigations, CAPA, change controls, and non‑conformance reports (NCRs).
• Lead internal, supplier, customer, and regulatory audits and inspections.
• Ensure effective complaint handling, root cause analysis, and corrective/preventive actions.
• Monitor quality metrics and prepare management review reports.
• Support product development, technology transfer, process validation, and qualification activities.
• Manage supplier qualification and vendor audits.
• Collaborate with Manufacturing, Engineering, Validation, Regulatory Affairs, R&D, and Supply Chain teams.
• Lead risk assessments using FMEA and other quality risk management tools.
• Drive continuous improvement initiatives using Lean, Six Sigma, and Kaizen methodologies.
• Mentor and develop QA/QC personnel while fostering a quality‑focused culture.

Requirements

• Bachelor's or Master's degree in Pharmacy, Biotechnology, Chemistry, Microbiology, Life Sciences, Engineering, or a related field.
• 815+ years of Quality Assurance and/or Quality Control experience in a regulated industry.
• Previous experience in a leadership or management role.
• Strong understanding of Quality Management Systems and regulatory compliance.