Director, GMP Quality Assurance

Role Overview:

• The Director, GMP QA provides QA support across Jade’s product pipeline, serving as a key partner to CMC and cross-functional teams.
• This role offers QA expertise, guidance, and risk-based input to support development and product quality strategies.
• The role provides QA oversight of contract manufacturers and service providers, ensuring alignment with GMP requirements and Jade quality standards.

Key Responsibilities:

• Serve as the QA lead for assigned GMP-related activities including quality oversight of CDMOs, tech transfer, scale-up, manufacturing, and disposition of clinical materials.
• Collaborate with CMC, Supply Chain, Analytical Development and Program Management to ensure on-time delivery and compliance with cGMP regulations.
• Lead quality risk management activities to proactively identify, assess, and mitigate GMP-related risks across manufacturing and supply operations.

Qualifications:

• Bachelor’s degree and 15 years of experience or a master’s degree with 12+ years of experience in a scientific discipline or comparable experience.
• 10+ years of experience in GMP Quality Assurance at an operational level supporting manufacturing and quality control in a pharmaceutical or biotech environment.
• Experience with all phases of development (Ph 1-4 including commercial) and in-depth knowledge of GMP FDA, EMA regulations, and ICH guidelines.