Supporting transition from legacy paper-based processes to a scalable and compliant Electronic Quality Management System (eQMS)
Ensuring Quality System supports all stages of drug development — from nonclinical development through clinical development, regulatory submission (IND, NDA/BLA), commercialization, and product lifecycle management
Ensuring compliance with applicable GxP requirements (GLP, GCP, GMP), applicable FDA and global regulatory expectations, and industry best practices
Supporting inspection readiness, regulatory submissions, vendor oversight, and fostering a culture of quality and compliance across the organization

Requirements

Bachelor's degree (BS) or higher in a scientific discipline (e.g., Biology, Chemistry, Pharmacy, Biomedical Sciences, or related field)
Direct experience of transitioning from paper-based systems to an Electronic Quality Management System (eQMS)
Familiarity with IND and NDA/BLA regulatory submissions
Regulatory agency inspections and inspection readiness
GxP environments (GLP, GCP, GMP)
Several years of progressive Quality experience in the pharmaceutical or biotechnology industry
Demonstrated experience supporting multiple stages of drug development: research, clinical development, regulatory submission, commercialization, and lifecycle management
Working knowledge of applicable regulations including 21 CFR Parts 210, 211, 312, 820 (if applicable), ICH guidelines, and related global standard
Experience with validating eQMS platforms and computerized system validation (CSV/CSA) is a plus.

Benefits

Competitive compensation for your work
Generous time off policy
Opportunity to broaden your horizons by attending popular conferences
Emphasis on work/life balance
Collaborative and team-oriented environment

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Electronic Quality Management System (eQMS)computerized system validation (CSV/CSA)regulatory submissiondrug developmentquality assurancevalidation of eQMS platformsGxP complianceinspection readinessvendor oversightlifecycle management

Soft Skills

fostering a culture of qualityorganizational skillscommunication skillsleadership skills