Senior QA Operations Lead — Biologics Manufacturing

Abzena Inc.; San Diego (CA); On-site; USD 100,000 - 120,000; Full time

Job summary

Abzena Inc. is seeking an experienced Quality Assurance Operations Supervisor to lead QA oversight across biologics manufacturing, including cell culture, fermentation, harvest, purification, and bulk drug substance.

You will supervise quality personnel, handle on-the-floor escalations, and support document review and approvals. The role partners with Manufacturing, Supply Chain, Facilities, and MSAT to meet production objectives while driving a culture of safety, compliance, and continuous

Qualifications

• Bachelor’s degree in Life Sciences, or related scientific discipline.
• Minimum 4 years of biopharmaceutical GMP manufacturing experience.
• Minimum 3 years in a Quality Assurance function.
• Minimum 2 years of leadership or supervisory experience.
• Hands-on experience with biologics operations in QA or Production.

Responsibilities

• Lead QA collaboration and oversight to staff, ensuring GDP, data integrity, and GxP readiness.
• Supervise on-the-floor production activities and verify procedures and regulatory compliance when departures occur.
• Lead batch record review on the floor for buffer/media/upstream and downstream records.
• Lead disposition of buffer/media solutions manufactured at Abzena.
• Supervise regular area walkthroughs of manufacturing, warehouse and Quality Control areas.
• Authorize deviations and perform root-cause analysis to drive remediation and improvements.
• Review and approve manufacturing deviations, risk assessments, CAPAs, change controls, and SOPs.
• Review and approve master batch records and client batch records.
• Support client and internal audits as required.
• Support other departments to fulfill business needs.
• Comply with Abzena’s policies and procedures.
• Communicate effectively with clients, colleagues and staff.
• Adhere to quality standards set by regulations and Abzena policies.

Skills

Biopharma manufacturing

Quality Assurance

Leadership

GMP compliance

Education

Bachelor's degree in Life Sciences or related field

Job description

Abzena Inc. is seeking an experienced Quality Assurance Operations Supervisor to lead QA oversight across biologics manufacturing, including cell culture, fermentation, harvest, purification, and bulk drug substance.

You will supervise quality personnel, handle on-the-floor escalations, and support document review and approvals. The role partners with Manufacturing, Supply Chain, Facilities, and MSAT to meet production objectives while driving a culture of safety, compliance, and continuous