Quality Engineering & CSA Director - GMP & Data Integrity

Serán BioScience; Bend (OR); On-site; USD 190,000 - 270,000; Full time

Benefits offered by this job

Over four weeks of paid time off annually

Employer 401(k) contributions after 90 days

Various health plans

Basic life and long-term disability coverage

Employee Assistance Program

Pet insurance access

Job summary

A dynamic biotechnology company in Bend, Oregon, seeks a Director of Quality Engineering & Computer System Assurance. This role involves strategic oversight of validation and computerized systems assurance for GMP manufacturing and laboratory operations. The ideal candidate has a background in FDA regulations and extensive experience in quality assurance. Responsibilities include leading validation lifecycle management, ensuring compliance, and fostering a culture of quality improvement. Offering competitive benefits and a supportive work environment.

Qualifications

• Broad knowledge of FDA and international regulations related to GMPs and Pharmaceuticals.
• Minimum of 10+ years previous GMP and Quality experience in the Pharmaceutical or Biotechnology industry.
• Demonstrated experience with regulatory inspections by the FDA and EU authorities.

Responsibilities

• Oversee validation lifecycle management for computerized systems.
• Lead initiatives to modernize validation practices.
• Provide leadership to cross-functional teams supporting validation activities.

Skills

FDA regulations knowledge

Computer System Validation expertise

Data integrity regulations understanding

Project management skills

Analytical problem-solving

Excellent communication

Leadership skills

Collaboration

Education

Bachelor’s degree in a scientific discipline

Advanced degree preferred

Tools

Microsoft Office Suite

Job description

A dynamic biotechnology company in Bend, Oregon, seeks a Director of Quality Engineering & Computer System Assurance. This role involves strategic oversight of validation and computerized systems assurance for GMP manufacturing and laboratory operations. The ideal candidate has a background in FDA regulations and extensive experience in quality assurance. Responsibilities include leading validation lifecycle management, ensuring compliance, and fostering a culture of quality improvement. Offering competitive benefits and a supportive work environment.