SENIOR QUALITY MANAGER - STERILE - Judge Group

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.