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.

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