QA Associate Director: Clinical Ops & Compliance

Serán BioScience; Bend (OR); On-site; USD 150,000 - 190,000; Full time

Job summary

Serán BioScience is seeking an Associate Director of Quality Assurance to oversee day-to-day QA operations, clinical manufacturing oversight, and warehouse activities, including disposition of raw materials and drug products. The role requires a results-driven QA leader with broad regulatory and quality systems experience.

You will lead continuous improvement, manage investigations, CAPAs, and inspections, mentor staff, and collaborate across functions to maintain cGMP compliance and timely

Qualifications

• Bachelor’s degree in scientific discipline; advanced degree preferred.
• 10+ years GMP and Quality experience in pharmaceutical manufacturing with oversight of OSD.
• Experience with FDA and EU regulatory inspections.

Responsibilities

• Lead and mentor QA personnel; oversee daily operations and staff development.
• Review investigations, CAPAs, complaints, and Change Management.
• Ensure cGMP compliance for raw materials, drug products, packaging, and warehouse.
• Manage department operations scheduling and continuous improvement initiatives.
• Support internal and regulatory audits and inspections.
• Define quality objectives and build cross-functional teams.
• Review SOPs and batch records; ensure release and disposition.

Skills

GMP knowledge

Quality assurance

Regulatory inspections

Leadership

Project management

Cross-functional

Investigations

Training mentoring

Communication skills

Problem solving

Change management

Client relations

People management

Quality systems

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Job description

Serán BioScience is seeking an Associate Director of Quality Assurance to oversee day-to-day QA operations, clinical manufacturing oversight, and warehouse activities, including disposition of raw materials and drug products. The role requires a results-driven QA leader with broad regulatory and quality systems experience.

You will lead continuous improvement, manage investigations, CAPAs, and inspections, mentor staff, and collaborate across functions to maintain cGMP compliance and timely