Description: Our client is currently seeking a Senior Quality Manager - Sterile Products. This is a permanent, direct hire position offering a hybrid work schedule near Newark, NJ
Overview:
Lead quality oversight for sterile products and medical devices across the product lifecycle while fostering collaboration with external business partners and CMOs.
Key Responsibilities:
Supervise direct reports, including goal setting and performance reviews.
Manage quality oversight for multiple product lines and partners.
Review and approve critical documentation: validations, SOPs, change controls, and product releases.
Support audits, inspections, and regulatory activities.
Oversee product release systems for US and ROW markets.
Drive process improvements and CAPA implementation.
Support technical transfers, validations, and troubleshooting.
Maintain metrics on quality systems and partner performance.
Qualifications:
BS in Pharmacy, Chemistry, Microbiology, or Biology with 15+ years in the pharmaceutical industry (10+ in quality roles).
Experience with sterile products, medical devices, FDA, and ICH guidelines.
Strong leadership, communication, technical writing, and organizational skills.
Contact: jgood@judge.com
This job and many more are available through The Judge Group. Find us on the web at www.judge.com
