Lead Change Control processes, including intake, coordination of review boards, tracking, and reporting of key metrics
Manage Quality Event records (e.g., deviations), including tracking, reporting, and facilitating cross-functional review meetings
Coordinate and oversee the APQR process, ensuring timely review, approval, and documentation
Support Quality Management Review meetings, including scheduling, content development, and follow-up on action items
Partner with internal teams to ensure alignment and continuous improvement of quality systems and processes
Assist other QS&C Team Members with routine activities

Requirements

Bachelor’s degree with 5+ years of experience in Quality Systems or Quality Assurance within pharma/biotech
Strong knowledge of GMPs, including Change Control, Quality Events, and APQR processes
Experience with Veeva Vault Quality Suite or similar eQMS platforms
Proven analytical, problem-solving, and project management skills
Excellent communication skills with the ability to collaborate across technical and non-technical teams
Proficiency in Microsoft Office (Excel, PowerPoint, Word, Outlook).

Benefits

Competitive salary and annual bonus.
Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
Generous parental leave and family planning benefits.
Outstanding culture and opportunities for personal and professional growth.

Applicant Tracking System Keywords

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

Hard Skills & Tools

Change ControlQuality Event managementAPQR processGMPsanalytical skillsproblem-solving skillsproject management skillsMicrosoft ExcelMicrosoft PowerPointMicrosoft Word

Soft Skills

communication skillscollaboration skills