QA Manager (Hybrid)
We are looking for a Quality Assurance Manager to lead Quality operations at a New Jersey facility with a customized global clinical trial supply management service company.
This role includes overseeing one direct report and is in need of an experienced, proactive Quality professional with a background in clinical trial packaging, pharmaceutical manufacturing, or distribution.
We are looking for a Quality Assurance Manager to lead Quality operations at a New Jersey facility with a customized global clinical trial supply management service company.
This role includes overseeing one direct report and is in need of an experienced, proactive Quality professional with a background in clinical trial packaging, pharmaceutical manufacturing, or distribution.
Key Responsibilities:
- Oversee the Quality Assurance function at the New Jersey site
- Manage and maintain all GMP-controlled documents
- Initiate and manage EQMS reports (Deviation, CAPA, Change Control)
- Qualify GMP equipment, systems, and facilities
- Ensure regulatory and quality documentation compliance with SOPs and regulatory standards
- Develop and conduct necessary Quality training for staff (GMP, SOPs)
Qualifications and Experience:
- At least 5 years of experience in a QA role within clinical trial packaging, pharmaceutical packaging, or distribution
- Degree or diploma from an accredited institution
- Proven leadership and team coaching abilities
- Comprehensive understanding of FDA and New Jersey Dept. of Health regulations
- Familiarity with Health Canada regulations is an advantage