Quality Assurance Manager

4 days ago


Hoffman Estates, Illinois, United States CMIC, Inc. Full time
Job Description

**About CMIC, Inc.**

CMIC, Inc. is a leading Bioanalytical Contract Research Organization (CRO) offering specialized services in support of pre-clinical and clinical developments. Our state-of-the-art laboratory in Hoffman Estates, Illinois, provides cutting-edge capabilities and sophisticated expertise in bioanalytical method development, method validation/qualification, and study sample analysis for small and large molecules.

**Job Summary**

We are seeking a highly skilled Quality Assurance Manager to provide oversight of our QA and QC business units. The successful candidate will lead the development and implementation of an independent quality system to support bioanalytical lab operations, identify areas of regulatory risk, and ensure compliance with GLP and regulatory requirements.

**Key Responsibilities**

  • Develop and execute training programs for employees on quality assurance policies, programs, and initiatives, as well as GLP regulatory requirements.
  • Review and approve procedures and quality documentation, ensuring compliance with company quality policies and procedures.
  • Conduct review of study data and final reports in support of regulatory submissions.
  • Mentor the Quality Assurance Team and monitor new developments in regulations.
  • Manage multiple teams and prioritize tasks to meet deadlines.
  • Communicate effectively with employees at all levels and handle confidential information with discretion.

**Requirements**

  • Strong understanding of FDA regulations relating to GLP, 21 CFR Part 58, and Part 11.
  • Sound understanding of quality systems and good documentation practices within a CRO, life science, and pharmaceutical industry.
  • Management experience and ability to handle multiple projects.
  • Excellent communication and interpersonal skills.
  • Ability to prioritize tasks and complete work in a timely fashion.
  • Good team player with experience dealing with complex tasks.
  • Excellent computer skills, including proficiency in Word, Excel, and PowerPoint.

**Education and Experience**

  • Bachelor's Degree; M.S. degree preferred with industry experience and/or equivalent.
  • 3+ years working in a GLP environment with 2+ years in a quality assurance or related role.
  • Team management experience.


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