Director, Quality Systems and Compliance

Responsibilities

• Design and improve the electronic Quality Management System (QMS)
• Oversee the maintenance of eQMS documentation to ensure compliance
• Manage GxP computerized systems validation and approval processes
• Develop, approve, and manage Standard Operating Procedures (SOPs)
• Administer the training management system and ensure training compliance
• Conduct internal audits and prepare for external inspections
• Promote a culture of quality and continuous improvement within the organization

Qualifications

• Bachelor's degree in STEM or related field or equivalent work experience
• Minimum 10+ years of experience in quality assurance and compliance
• Hands-on experience with electronic QMS administration, including LMS
• Strong knowledge of QMS principles and GxP requirements (GCP/GLP and GMP)
• Proven experience leading FDA/regulatory inspections
• Track record in the animal health QA sector
• Exceptional writing, organizational, and communication skills
• Ability to manage multiple projects in a regulated environment

Benefits

• Full-coverage health insurance for you and dependents
• $1,000 home office equipment stipend
• $1,200/year learning budget
• $250/month wellness budget
• 4-day weekends every week
• Unlimited vacation and paid holidays
• Paw-ternity leave for new dog adopters
• Company equity options for new hires