Provide guidance and leadership for the CSV Auditing group
Build strategic partnerships and implement risk-based quality auditing activities across GDQA
Lead audits of higher complexity (e.g., directed audits)
Schedule, prepare, conduct, report and follow-up on routine and directed CSV audits
Support other GxP (GCP, GLP, GVP) audits as a CSV SME
Guide and train team members

Requirements

Bachelor’s degree (Master’s degree preferred)
6+ years of relevant proven experience
4+ years of direct CSV/IT audit experience preferred
Must understand GxP regulations/principles
Previous experience with European, FDA or other Regulatory Inspections of Marketing Authorization Holders or CROs
Ability to optimally communicate across a global organization to key partners
Capability to work autonomously and navigate ambiguous situations
Strong project management, customer management, teamwork skills and negotiation of sophisticated situations

Benefits

health and wellness programs (including medical, dental, vision, life, and disability insurance)
fitness centers
401(k) company match
family support benefits
equity awards
annual bonuses
paid time off
paid leaves (e.g., military and parental leave)

Applicant Tracking System Keywords

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

Hard Skills & Tools

CSV auditingGxP regulationsrisk-based quality auditingdirected auditsproject managementcustomer managementteamworknegotiation

Soft Skills

leadershipcommunicationautonomynavigating ambiguityguidancetraining

Certifications

Bachelor’s degreeMaster’s degree