Senior Director, Quality Assurance

What you'll do

• Build and maintain the QMS, including CAPA, deviations, change control, training, document management, and SOPs.
• Oversee vendor and site qualification and audits, product release activities, clinical quality, and regulatory inspection readiness.
• Set data-integrity and validation practices for AI/ML-enabled workflows in collaboration with Compute and Data Science.

What they ask for

• 12+ years in pharma or biotech quality, with progression into senior QA leadership.
• Advanced a molecule from preclinical development through IND and into Phase 2 or beyond in a resource-constrained, substantially outsourced environment.
• Deep expertise in either GMP or GCP and working competence in the other; participated in a sponsor-side FDA GMP or BIMO inspection.
• Hands-on QMS building or configuration experience, plus grounding in data integrity and computer system validation, including ALCOA+, 21 CFR Part 11, GAMP 5 categorization, and audit trail review.

Pay

USD $273,000 - $290,000 base salary

Tools

ZenQMS, Veeva Vault QMS, Qualio, MasterControl, TrackWise, ALCOA+, 21 CFR Part 11, GAMP 5

AI focus

Define data integrity, documentation, change control, and validation approaches for AI/ML outputs used in patient and biomarker selection and trial design; address model drift and evolving algorithms under regulatory scrutiny.