Quality Assurance Manager

We are seeking an experienced Quality Assurance professional to support clinical packaging and labeling operations within a GMP-regulated pharmaceutical environment. The ideal candidate will oversee quality activities related to clinical trial materials, ensuring compliance with GMP requirements and applicable quality standards.

Required Qualifications:

• Bachelor's degree in a scientific discipline, Pharmaceutical Sciences, or a related field.

• 7+ years of experience in Pharmaceutical Quality Assurance, Quality Operations, or GMP-regulated environments.

• Hands-on experience with clinical packaging and labeling operations.

• Strong knowledge of GMP requirements, Investigational Medicinal Products (IMPs), and clinical supply processes.

• Experience reviewing batch records, managing deviations, CAPAs, change controls, and quality documentation.

• Experience working with Contract Manufacturing Organizations (CMOs) and external pharmaceutical vendors.

• Strong technical writing, communication, organizational, and risk assessment skills.

Preferred Qualifications:

• Experience supporting early-phase clinical development programs.

• Experience with vendor quality oversight, audits, and quality agreements.

• Familiarity with electronic Quality Management Systems (eQMS) and document management platforms.

• Ability to manage multiple priorities in a fast-paced clinical supply environment.