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Quality Assurance Lead
2 months ago
CMIC, Inc. is a prominent Contract Research Organization (CRO) specializing in bioanalytical services to support toxicokinetic and pharmacokinetic studies for both pre-clinical and clinical development phases.
We are seeking a **Quality Assurance Lead** to oversee the QA and QC divisions. This role involves spearheading the development and execution of an independent quality management system tailored for bioanalytical laboratory operations. The successful candidate will identify regulatory risks and communicate these to laboratory and senior management.
Key Responsibilities:
- Develop and deliver training programs for all employees on quality assurance policies, programs, and GLP regulatory requirements.
- Ensure compliance with company quality standards and GLP regulations during document reviews and process implementations.
- Draft, review, and approve quality documentation and procedures as necessary.
- Conduct thorough reviews of study data and final reports to support regulatory submissions.
- Mentor the Quality Assurance Team and stay updated on evolving regulations.
Qualifications:
- In-depth knowledge of FDA regulations related to GLP, specifically 21 CFR Part 58 and Part 11.
- Strong understanding of quality systems in the contract research sector, including good documentation practices.
- Experience managing multiple teams and projects effectively.
- Excellent time-management skills with the ability to prioritize tasks efficiently.
- Proficient oral and written communication skills, with the ability to interact with personnel at all levels.
- Detail-oriented with strong organizational skills for managing confidential information.
- Proactive and able to demonstrate initiative.
- Team-oriented with experience in handling complex tasks.
- Strong computer skills, including proficiency in Word, Excel, and PowerPoint, with a willingness to learn new systems.
Education:
Bachelor's Degree required; a Master's degree is preferred, along with relevant industry experience in pharmaceutical or bioanalytical settings.
Minimum of 3 years in a GLP environment, with at least 2 years in a quality assurance or related capacity, including team management experience.
Company OverviewCMIC is a leading Bioanalytical Contract Research Organization (CRO) providing services for small molecules, large molecules, biomarkers, and oligonucleotides. Our state-of-the-art laboratory in Hoffman Estates, Illinois, is designed to facilitate seamless method and knowledge transfer, reflecting our commitment to quality and efficiency.
