QA Training & Document Control Manager

Abzena; San Diego (CA); On-site; USD 100,000 - 150,000; Full time

Job summary

Abzena, a leading CDMO, seeks a Quality Assurance Manager to lead the Document Control and Training teams in a GMP-regulated environment. You will manage the document management program, collaborate with Quality leadership on strategic quality initiatives, and ensure timely delivery of controlled documents and training to satisfy regulatory and site requirements.

Ideal candidates have 7+ years in QA within GMP settings, 3–5 years of people leadership, and strong written/verbal communication

Qualifications

• Bachelor-level degree in science or related field required.
• Minimum 7 years in Quality Assurance within GMP-regulated environments.
• 3–5 years of direct people leadership experience.
• Excellent written and verbal communication skills.
• Experience with regulatory inspections, client/internal audits, and GDP/good documentation practices.

Responsibilities

• Direct leadership of Document Control and Training teams and functions.
• Manage the document management and training program.
• Partner with Quality leadership to drive short- and long-term quality initiatives.
• Ensure timely delivery of documents and training to meet regulatory and site goals.
• Lead daily tasks in Document Control and Training; operate in team and solo settings.
• Maintain and improve the global Document Control system and SOPs, batch records, and related documents.
• Issue control documents, logbooks, and archival records; track workflows to ensure on-time completion.
• Evaluate quality processes for continuous improvement and provide quality metrics.
• Support QMS and CSV qualification activities as required.
• Conduct internal audits of document control and training processes.

Skills

Leadership

Communication

GMP knowledge

Regulatory inspections

Multitasking

Documentation practices

Education

BS/BA degree, preferably in science

Tools

Microsoft Office

Job description

Abzena, a leading CDMO, seeks a Quality Assurance Manager to lead the Document Control and Training teams in a GMP-regulated environment. You will manage the document management program, collaborate with Quality leadership on strategic quality initiatives, and ensure timely delivery of controlled documents and training to satisfy regulatory and site requirements.

Ideal candidates have 7+ years in QA within GMP settings, 3–5 years of people leadership, and strong written/verbal communication