Sr. Manager, CQA GLP
$146,410–$192,164 year
Hybrid · Somerset, New Jersey, United States
Job Summary
Sr. Manager, GLP - CQA responsible for GLP quality oversight of nonclinical studies and auditing of external vendors, with ownership of QA processes, SOP development/review, and ensuring GCP/GLP compliance. Will support deviations, data integrity review, and collaboration with cross-functional study teams to reinforce a quality culture. Located in Somerset, NJ with a hybrid work schedule (2-3 days on-site) and reporting to the Sr. Director of Clinical Quality Assurance. Key activities include GLP QA system management, vendor audits, cross-functional data review, development of GLP-related SOPs/training, and preparation for inspections and regulatory interactions. Requirements include a bachelor’s degree in biology/biochemistry/life sciences, 3 years GLP QA experience in biologics, auditing experience, CRO/vendor interaction experience, strong communication skills, and knowledge of FDA/ICH GCP guidelines.
Required Qualifications
- Bachelor’s degree in biology, biochemistry, or the life sciences
- English communication
- A minimum of 3 years (Sr. Manager) or 1 year (Manager level) of related industry experience in Quality
- 3 years of experience in GLP Quality in laboratories testing biologics
- Experience auditing GLP testing labs
- Experience working with CROs, vendors, and relationship management
- Ability to work with diverse employees and customers
- Strong project management skills
- Knowledge of FDA, ICH GCP guidelines, and GLP regulations
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