Associate Director CMC Quality

About Aerogen Pharma:

Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company with a mission to develop inhaled drug/biologic and device combination products. At Aerogen Pharma, our advanced science starts with a deeply human purpose: improving outcomes and access to medicines for preterm infants and other critically ill patients with life-threatening respiratory diseases around the globe. We bring together patient and healthcare system understanding, pharmaceutical innovation and advanced aerosol delivery technology to develop inhaled therapies designed specifically for the unique needs of the world’s most vulnerable patients.

We are a growing company at an exciting and dynamic stage in our development. Our portfolio includes APC-0101, an aerosolized surfactant currently in phase 3 clinical trial and APC-0201, a synthetic surfactant currently in pre-clinical development. Each of these products are designed to treat respiratory distress syndrome in premature infants and together set a foundation for exciting future opportunities.

Joining Aerogen Pharma means becoming part of an experienced, dedicated team working collaboratively to advancing respiratory and critical care through innovation. Our “We Care” culture is reflected in how we work together creating a welcoming, inclusive environment where people make time to support one another, share their expertise and ensure every team member feels connected and empowered to contribute. At Aerogen Pharma, the work you do every day will have direct impact to the advancement of meaningful development programs as you collaborate with experienced leaders and experts across the pharmaceutical and medical technology industries

What is the role?

The Associate Director, CMC Quality Assurance is a senior Quality leader accountable for providing strategic and hands-on GMP quality oversight across Aerogen Pharma's development programs. The position serves as the primary Quality partner to CMC, Device, Supply Chain, Regulatory Affairs, Clinical Supply, Program Leadership, and external manufacturing and testing partners, ensuring that development activities are executed with appropriate quality rigor, regulatory compliance, and phase-appropriate systems while preserving the speed and pragmatism required in an entrepreneurial pharmaceutical company. Reporting to the VP of Quality Assurance, the Director CMC Quality Assurance role requires a leader who can move seamlessly between strategic Quality decision-making and detailed execution: establishing GMP quality strategy, challenging technical and compliance assumptions, making risk-based decisions, resolving issues in real time, and personally driving critical work when resources are constrained or timelines are compressed.

What are the key 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.

What education and experience are required?

• 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 the pharmaceutical or biotechnology industry, 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 practical application of 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 relevant global regulatory expectations, including FDA, Health Canada, MHRA, and other applicable health authority requirements.

What key skills will make you great at the role?

• Senior-level Quality judgment with the ability to distinguish material compliance risk from issues that can be managed pragmatically and proportionately.
• Comfort operating in ambiguity, with incomplete information, changing priorities and limited resources while maintaining control of critical Quality risks.
• High sense of ownership, urgency, accountability and follow-through; willing to roll up sleeves and drive work to closure rather than only advise from the sidelines.
• Excellent written and verbal communication skills, including the ability to communicate complex Quality and compliance matters in concise, decision oriented language to senior leaders and external partners.
• Credibility and confidence to challenge cross-functional leaders and external partners constructively, while building trusted and collaborative relationships.
• Pragmatic, solutions-oriented leadership style with a continuous improvement mindset and strong commitment to patient safety, product quality, data integrity and regulatory compliance.
• Audit experience is preferred.
• Experience developing, monitoring, and reporting Quality metrics and Key Performance Indicators (KPIs) is preferred.
• Candidates can be based in either Morrisville, North Carolina or San Mateo, California to be considered for this role.
• Must be available for Travel within US, up to 30% of time.

Why Aerogen Pharma?

As a key member of Aerogen Group, the global market leader in high-performance aerosol drug delivery, Aerogen Pharma is at a pivotal point in the company's life cycle. With plans to expand and centralize our US hubs over the next two years, we offer an environment where you can thrive professionally and learn from driven industry leaders in drug development and commercialization, inhaled devices and neonatology. We foster an inclusive culture that empowers you to contribute to the transformation of Neonatal care, where potential is recognized and professional development is encouraged.

Equal Employment Opportunity

Aerogen Pharma is committed to providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status or any other characteristic protected by applicable law. Salary Range for this position is estimated at $165,000-$205,000 and will depend on the candidate's skills, qualification and experience. The role is eligible for a performance-based incentive bonus and comprehensive benefit package including Medical, Dental, and Vision Coverage, 401k Retirement, Enhanced Global Life Insurance, Paid Time Off (15-20 days tenure related), Global EAP Program, Short-Term Disability and FMLA Benefits. The company reserves the right to adjust this pay range at any time.

City

Candidates based in either San Mateo, California or Morrisville, North Carolina will be considered for this role.