Commercial QC Director - Quality Control Leader

Serán BioScience; Bend (OR); On-site; USD 180,000 - 280,000; Full time

Benefits offered by this job

Paid time off

Retirement plan

Health insurance

Employee assistance program

Job summary

Serán BioScience seeks a Director of Commercial Quality Control to lead and direct QC operations supporting commercial manufacturing and late-stage clinical programs. The role ensures GMP compliance, data integrity, and readiness for regulatory inspections, while aligning with stakeholders and external partners.

Responsibilities include staffing, training, performance management, and driving continuous improvement across laboratories, stability programs, and material testing to support timely

Qualifications

• B.S./M.S. in chemistry or related discipline; 5+ years QC management experience; 10+ years related experience preferred (CDMO experience preferred).
• Expert level knowledge of drug product and raw material release and stability testing, industry expectations, methods, and systems for pharmaceutical products.
• Working knowledge of regulatory requirements including cGMP, FDA/EU, ICH and USP.

Responsibilities

• Lead and develop a high-performing Quality Control organization.
• Provide mentoring, coaching, and professional development for staff; conduct performance evaluations.
• Establish departmental goals aligned with quality and operational objectives.
• Oversee laboratory operations to ensure staffing, qualification, and inspection readiness.
• Drive continuous improvement initiatives to enhance laboratory effectiveness and compliance.

Skills

GMP QC leadership

Regulatory inspections

Leadership & people management

Project management

Communication skills

Analytical/problem solving

Cross-functional collaboration

Time management

Education

B.S./M.S. in chemistry or related discipline

5+ years QC management experience

10+ years related experience

Tools

Microsoft Office Suite

Job description

Serán BioScience seeks a Director of Commercial Quality Control to lead and direct QC operations supporting commercial manufacturing and late-stage clinical programs. The role ensures GMP compliance, data integrity, and readiness for regulatory inspections, while aligning with stakeholders and external partners.

Responsibilities include staffing, training, performance management, and driving continuous improvement across laboratories, stability programs, and material testing to support timely