Strategic CMC Quality Leader – Associate Director

Aerogen Pharma; Foster City (CA); Sur place; USD 165 000 - 205 000; Plein temps

Avantages offerts par ce poste

Medical coverage

Dental coverage

Vision coverage

401k Retirement

EAP

Résumé du poste

Aerogen Pharma is seeking an Associate Director, CMC Quality Assurance to provide strategic and hands-on GMP quality oversight across development programs. Reporting to Quality leadership, you will shape the GMP strategy, lead risk-based decisions, and drive quality across CMC, device interfaces, and external partners.

You will manage deviations, CAPA, change control, and quality systems while ensuring readiness for regulatory submissions.

Qualifications

• 15+ years of progressive Quality Assurance experience in pharma/biotech with substantial CMC/GMP responsibility.
• Experience with inhaled drug development or drug–device combinations is a plus.
• Demonstrated experience providing Quality oversight of CDMOs, contract labs, vendors and development partners.
• Depth in managing pharmaceutical quality systems and GMP requirements (deviations, investigations, CAPA, change control, validation, documentation).
• Working knowledge of global regulatory expectations (FDA, Health Canada, MHRA, MDR, ISO 13485/14971).

Responsabilités

• Lead CMC Quality strategy across development programs with phase-appropriate GMP controls.
• Act as senior Quality partner to CMC, Device, Regulatory Affairs, Clinical Supply, and external partners.
• Provide GMP oversight for drug substance, drug product, device interfaces, analytical testing, stability, packaging and labeling.
• Govern core Quality Systems: deviations, investigations, CAPA, change control, risk management, validation, documentation, training.
• Oversee CDMOs, contract labs, suppliers; manage quality agreements, audits, remediation and KPI tracking.
• Drive regulatory readiness and support for inspections and health authority inquiries.

Connaissances

Quality leadership

GMP compliance

Risk assessment

Vendor oversight

Regulatory readiness

Documentation control

CAPA management

Formation

Bachelor’s degree in science

MS/PhD preferred

Outils

QMS software

Documentation systems

Description du poste

Aerogen Pharma is seeking an Associate Director, CMC Quality Assurance to provide strategic and hands-on GMP quality oversight across development programs. Reporting to Quality leadership, you will shape the GMP strategy, lead risk-based decisions, and drive quality across CMC, device interfaces, and external partners.

You will manage deviations, CAPA, change control, and quality systems while ensuring readiness for regulatory submissions.