API Stability & Quality Assurance Lead

Jobtailor; New Jersey; On-site; USD 120,000 - 170,000; Full time

Job summary

Jobtailor is seeking a Senior Stability Leader in the United States (New Jersey) to oversee API and drug product stability programs. You will author protocols, manage sample handling, and drive lifecycle activities while supporting audits and regulatory filings.

Role requires a Bachelor’s in a technical field and at least 6 years in pharma/biotech/medical devices, with GMP knowledge and strong quality process expertise. Travel 5–10% may be needed.

Qualifications

• Bachelor’s degree in a technical/scientific discipline is required.
• Minimum 6 years of relevant industry experience in pharma/biotech/medical devices.
• Experience with API and drug product stability and GMP regulations is preferred.
• Strong knowledge of quality systems (change control, CAPA, risk management) is required.

Responsibilities

• Serve as stability point of contact for assigned API and drug product families.
• Oversee stability sample management and related documentation.
• Author and oversee stability protocols and stability reports per global SOPs.
• Support audits and regulatory filings related to stability questions.
• Manage stability lifecycle activities and continuous improvement initiatives.
• Support QA/operations partners with stability inquiries and investigations.
• Coordinate with Stability Labs to address questions promptly.
• Assist with stability notifications, excursions, and change controls.
• Maintain stability statements for assigned products.
• Contribute input during staff meetings to improve stability processes.

Skills

Stability Sample Management

Stability Protocol Authoring

Change Control

CAPA

Risk Management

Pharmaceutical Processes

Product Quality Assurance

Product Development

GMP Regulations

Temperature Excursion Management

Education

Bachelor’s degree in Pharmacy, Chemistry, Biology, Biochemistry, Engineering, or similar

Job description

Jobtailor is seeking a Senior Stability Leader in the United States (New Jersey) to oversee API and drug product stability programs. You will author protocols, manage sample handling, and drive lifecycle activities while supporting audits and regulatory filings.

Role requires a Bachelor’s in a technical field and at least 6 years in pharma/biotech/medical devices, with GMP knowledge and strong quality process expertise. Travel 5–10% may be needed.