Senior Director, Commercial Quality Control & Compliance

Serán BioScience; Bend (OR); Sur place; USD 180 000 - 260 000; Plein temps

Avantages offerts par ce poste

Paid time off

Health plans

Retirement plan

Life Insurance

Disability

Employee assistance program

Pet insurance

Résumé du poste

Serán BioScience seeks a Director of Commercial Quality Control to lead and shape the QC function for commercial and late-stage product testing. You will ensure compliant release testing, stability programs, and data integrity while aligning with regulatory expectations and business objectives.

The role requires strong leadership, strategic oversight, and cross-functional collaboration in a fast-paced environment.

Qualifications

• 5+ years of QC management experience in pharmaceutical settings.
• 10+ years related experience preferred.
• Experience with drug product release and stability testing.
• Regulatory knowledge including FDA/EU guidelines and cGMPs.

Responsabilités

• Lead and develop a high-performing QC organization.
• Ensure inspection readiness and regulatory readiness across laboratories.
• Oversee raw material, in-process, and finished product testing.
• Drive continuous improvement and data integrity across quality systems.
• Manage external laboratory oversight and vendor relationships.

Connaissances

GMP QC operations

Regulatory inspections experience

Data integrity

Stakeholder collaboration

Leadership and people development

Process improvement

Quality systems

Formation

B.S. / M.S. in chemistry, pharmaceutical sciences, or related discipline

Description du poste

Serán BioScience seeks a Director of Commercial Quality Control to lead and shape the QC function for commercial and late-stage product testing. You will ensure compliant release testing, stability programs, and data integrity while aligning with regulatory expectations and business objectives.

The role requires strong leadership, strategic oversight, and cross-functional collaboration in a fast-paced environment.