Senior Quality Control Leader - cGMP & Compliance

Silgan Dispensing; Spokane (WA); On-site; USD 100,000 - 120,000; Full time

Job summary

Silgan Dispensing in Spokane, WA seeks an experienced Quality Control leader to oversee QC operations for both commercial and development-stage products. You will develop and implement QC systems to ensure cGMP compliance and provide coaching and performance management for laboratory staff.

Lead inspections, audits, and CAPA processes while driving continuous improvement across analytical and microbiology testing, environmental monitoring, and stability programs.

Qualifications

• Bachelor's degree in a related scientific discipline.
• 10+ years of progressive Quality Control experience in pharmaceutical/biotech/manufacturing environments.
• 5+ years of leadership or management experience.
• Experience supporting FDA-regulated manufacturing operations.
• Strong knowledge of 21 CFR Part 11, Part 210, Part 211, Part 820; ISO 13485/14644.
• Hands-on lab experience in analytical and microbiological testing.
• Experience with OOS Phase I and Phase II investigations.
• Excellent technical writing and investigative skills.

Responsibilities

• Direct and manage Quality Control operations supporting commercial and development-stage products.
• Develop, implement, and maintain QC systems and procedures to ensure cGMP compliance.
• Provide leadership, coaching, mentoring, and performance management for laboratory personnel.
• Establish departmental goals, metrics, and continuous improvement initiatives.
• Serve as QC subject matter expert during regulatory inspections and audits.

Skills

Leadership

Quality control

Regulatory compliance

Process improvement

Problem solving

Coaching

Education

Bachelor's degree in Microbiology, Biology, Chemistry, Pharmaceutical Sciences, Engineering, or related

Tools

LIMS

Electronic quality systems

Job description

Silgan Dispensing in Spokane, WA seeks an experienced Quality Control leader to oversee QC operations for both commercial and development-stage products. You will develop and implement QC systems to ensure cGMP compliance and provide coaching and performance management for laboratory staff.

Lead inspections, audits, and CAPA processes while driving continuous improvement across analytical and microbiology testing, environmental monitoring, and stability programs.