Associate Director, QC Operations
$130k/y-$170k/y
ClinLab Staffing2 days ago
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OnsiteFull-timeDirector
Summary
ClinLab Solutions Group is seeking an Associate Director, QC Operations to join their team in Hopewell, NJ. The role involves leading analytical strategy, method lifecycle management, and QC operations to support GMP testing and release of materials, intermediates, and finished products.
About the Role
As an Associate Director, QC Operations, you will be responsible for developing and overseeing quality control procedures for GMP testing, leading laboratory investigations, managing assay development, and providing technical guidance for regulatory submissions. You will coordinate analytical testing, train laboratory personnel, and ensure compliance with regulatory standards while collaborating cross-functionally to support product life-cycle timelines.
About You
Required:
- Bachelor’s degree in Biology or related field and 8+ years of experience in analytical sciences and GMP/GLP environments.
- Minimum 5 years of managerial experience leading teams and projects.
- Working knowledge and experience with chemistry analytical methods such as HPLC, GC, TOC, and Capillary Electrophoresis.
- Strong understanding of GMP/GLP regulations.
- Excellent project management and cross-functional collaboration skills.
Preferred:
- Master’s degree in a relevant field.
- Hands-on experience in analytical team building with strong problem-solving skills.
- Conversant with ICH guidelines and applicable laws and regulations of major markets.
- Experience in CMC document preparation for IND and NDA filing.
Benefits
- Competitive salary range of $130k–$170k.
- Comprehensive benefits package including health insurance and retirement plans.
ClinLab Staffing
ClinLab Staffing was created in 2002 to provide recruitment and career solutions within pharmaceutical, biotech, and med-device companies, CROs and CMOs, hospitals and medical schools. Let us help advance your goals, as you concentrate on science and we concentrate on talent development and success.
Hopewell, NJ