Sr. Director, GMP Quality Assurance - Remote

Overview

The Sr. Director, GMP Quality Assurance will provide leadership, direction, and Quality Assurance (QA) oversight of contract manufacturers (CMOs) and service providers for cell bank, drug substance (DS), drug product (DP), packaging and labeling, and distribution of multiple products.

In Short

• Serve as the QA lead for all GMP-related activities including supplier qualification and tech transfer.
• Quality reviewer and approver for various quality records.
• Collaborate with CMC, Supply Chain, and Program Management.
• Manage quality oversight of CDMOs.
• Represent the Quality function in product development teams.
• Lead quality risk management activities.
• Facilitate resolution of quality issues.
• Review and approve CMC sections of regulatory filings.
• Contribute to a positive team-focused company culture.

Requirements

• Bachelor’s degree and 17+ years of experience or a Master’s degree and 15+ years of experience in a scientific discipline.
• 15 years of experience in GMP Quality Assurance in a pharmaceutical or biotech environment.
• In-depth knowledge of GMP FDA, EMA regulations, and ICH guidelines.
• Experience managing CDMOs and performing person-in-plant.
• Experience with technology transfer, scale up, and validation.
• Strong communication and influencing skills.
• Ability to thrive in a fast-paced environment.

Benefits

• Competitive salary range of $255,000 - $275,000.
• Remote work flexibility with periodic travel required.
• Opportunity to lead QA efforts for innovative therapies.
• Collaborative work environment with cross-functional teams.
• Supportive company culture focused on teamwork and development.