Senior CMC Quality Leader – Inhalation Drug/Device

Aerogen Ltd.; Foster City (CA); On-site; USD 165,000 - 205,000; Full time

Benefits offered by this job

Medical, Dental, Vision Coverage

401k Retirement Plan

Life Insurance

Paid Time Off (15-20 days)

Global EAP Program

Short-Term Disability & FMLA

Job summary

Aerogen Pharma, a US-based clinical-stage specialty pharmaceutical company, seeks an Associate Director, CMC Quality Assurance to lead GMP quality oversight across development programs, reporting to the VP of Quality Assurance. This role partners with CMC, Device, Regulatory Affairs and external partners to ensure quality and regulatory readiness while maintaining speed in an entrepreneurial environment.

The ideal candidate has 15+ years in pharmaceutical QA with CMC/GMP leadership, experience

Qualifications

• Bachelor’s degree in a scientific, engineering or related discipline required; advanced degree (MS or PhD) preferred.
• Minimum of 15+ years of progressive Quality Assurance experience in pharma/biotechnology, with substantial responsibility for CMC and GMP activities; experience with inhaled drug development and/or drug‑device combination products is a plus.
• Demonstrated experience providing Quality oversight of CDMOs, contract laboratories, vendors and development partners.
• Depth in managing pharmaceutical quality systems and GMP requirements, including deviations/investigations, CAPA, change control, validation/qualification, documentation, supplier quality, risk management, QMS compliant 21 CFR Parts 4, 210/211, 600/601 and 820 (QMSR), EudraLex Vol. 4 & Annexes, MDR 2017/745, ISO 13485 and 14971
• Working knowledge of ICH and global regulatory expectations, including FDA, Health Canada, MHRA, and other applicable health authority requirements.

Responsibilities

• Own and execute the CMC Quality strategy across development programs, ensuring phase‑appropriate GMP controls, decision frameworks, and readiness for registration and commercialization.
• Serve as the senior Quality partner to CMC, Device, Regulatory Affairs, Clinical Supply, Supply Chain, Program Leadership, and external partners, providing independent, risk‑based Quality judgment.
• Provide GMP oversight for drug substance, drug product, device and drug‑device combination interfaces, analytical testing, stability, packaging, labeling, clinical supply, and related CMC operations.
• Ensure effective governance and execution of core Quality Systems, including deviations, investigations, CAPA, change control, risk management, validation and qualification, documentation practices, training, and applicable complaint processes.
• Lead Quality oversight of CDMOs, contract laboratories, suppliers, and other external CMC partners, including quality agreements, performance management, issue escalation, audits, remediation, and sustainable closure of commitments.
• Provide Quality leadership for process and analytical development, scale‑up, technology transfer, validation strategy, manufacturing readiness, and transition from clinical to commercial controls.
• Lead Quality risk assessments for complex CMC, compliance, supply, and partner issues, defining pragmatic mitigation strategies, contingency plans, decision thresholds, and escalation pathways.
• Drive inspection and regulatory readiness for assigned CMC areas, including documentation quality, traceability, issue history, partner readiness, and support for health authority questions or findings.
• Support preparation for and participation in regulatory and government agency inspections.
• Act as a hands‑on senior Quality leader who influences across the matrix, challenges constructively, creates alignment, and implements scalable improvements that strengthen accountability, compliance, and execution speed.
• Contribute to the design, implementation, and continuous improvement of robust Quality Management Systems (QMS), including document control, deviation management, Corrective and Preventive Actions (CAPA), and change control.
• Support the development, coordination, and delivery of Quality and GxP training activities.

Skills

Quality judgment

Communication

Cross-functional collaboration

Ambiguity tolerance

Ownership & accountability

Regulatory compliance

Auditing experience

KPIs & metrics

Travel availability

CDMO management

Education

Bachelor's degree in scientific/engineering field

MS/PhD preferred

Job description

Aerogen Pharma, a US-based clinical-stage specialty pharmaceutical company, seeks an Associate Director, CMC Quality Assurance to lead GMP quality oversight across development programs, reporting to the VP of Quality Assurance. This role partners with CMC, Device, Regulatory Affairs and external partners to ensure quality and regulatory readiness while maintaining speed in an entrepreneurial environment.

The ideal candidate has 15+ years in pharmaceutical QA with CMC/GMP leadership, experience