Senior CMC Quality Leader – GMP, Drug/Device

Aerogen Pharma; Raleigh (NC); On-site; USD 165,000 - 205,000; Full time

Benefits offered by this job

Performance‑based incentive bonus

Medical, Dental, Vision coverage

401k Retirement

Job summary

Aerogen Pharma is seeking an Associate Director, CMC Quality Assurance to provide strategic and hands‑on GMP quality oversight across development programs. You will partner with CMC, Device, Regulatory Affairs, Clinical Supply, and external manufacturers to ensure compliance while preserving speed in a dynamic startup environment.

The role requires 15+ years in pharmaceutical quality, deep knowledge of GMPs, and a proven ability to lead quality decisions, risk assessments, and inspections.

Qualifications

• Bachelor’s degree in a scientific, engineering or related discipline required; advanced degree preferred.
• Minimum 15+ years of progressive Quality Assurance experience in pharmaceutical/biotech with CMC/GMP focus.
• Experience with CDMOs, contract labs, vendors and development partners.

Responsibilities

• Own and execute the CMC Quality strategy across development programs with phase‑appropriate GMP controls.
• Serve as senior Quality partner to CMC, Device, Regulatory, Clinical Supply, Supply Chain, and external partners.
• Provide GMP oversight for drug substance/product, device interfaces, analytics, stability, packaging, labeling and clinical supply.

Skills

Quality leadership

Regulatory comprehension

Risk management

Communication

Accountability

Continuous improvement

Audits

KPIs

Travel up to 30%

Education

Bachelor's degree

MS or PhD preferred

Job description

Aerogen Pharma is seeking an Associate Director, CMC Quality Assurance to provide strategic and hands‑on GMP quality oversight across development programs. You will partner with CMC, Device, Regulatory Affairs, Clinical Supply, and external manufacturers to ensure compliance while preserving speed in a dynamic startup environment.

The role requires 15+ years in pharmaceutical quality, deep knowledge of GMPs, and a proven ability to lead quality decisions, risk assessments, and inspections.