Senior QA Lead, External CMOs - GMP Compliance

Initial Therapeutics, Inc.; Basking Ridge (NJ); On-site; USD 153,600 - 230,400; Full time

Job summary

Initial Therapeutics, Inc. is hiring for a QA management role focusing on ensuring compliance within contract manufacturing operations. The role involves oversight of Quality Management Systems, partnering with quality leaders, and supporting validation efforts for drug products.

Ideal candidates will have over 7 years in the pharmaceutical sector, understanding regulatory compliance, and are expected to frequently collaborate across functional teams. The position includes travel requirements of up to 30% and offers a competitive salary range.

Qualifications

• Bachelor’s Degree in scientific discipline required; advanced degree preferred.
• 7+ years in pharmaceutical operations including knowledge of drug manufacturing.
• Experience with contract manufacturing organizations is required.

Responsibilities

• Ensure robust Quality Management System compliance with industry guidelines.
• Support drug product management and operational activities.
• Participate in cross-functional teamwork with Quality Leaders.

Skills

Knowledge of drug manufacturing

Quality management principles

Experience in contract manufacturing

Aseptic/Sterile Manufacturing

Ability to work in a project environment

Education

Bachelor’s Degree in scientific discipline

Master’s Degree or advanced degree preferred

Job description

Initial Therapeutics, Inc. is hiring for a QA management role focusing on ensuring compliance within contract manufacturing operations. The role involves oversight of Quality Management Systems, partnering with quality leaders, and supporting validation efforts for drug products.

Ideal candidates will have over 7 years in the pharmaceutical sector, understanding regulatory compliance, and are expected to frequently collaborate across functional teams. The position includes travel requirements of up to 30% and offers a competitive salary range.