Develop standard operating procedures, work instructions, forms, and templates to ensure a fit-for-purpose clinical auditing and inspection management program to ensure compliance with Good Clinical Practice(GCP)/Good Pharmacovigilance Practice(GPvP)/Good Clinical Laboratory Practice (GpLP).
Develop dynamic, risk-based audit strategy and plan for critical sponsor processes and systems, clinical trials, investigator sites, and vendors/contract service providers (CSPs).
Plan, lead, conduct, document, report, and follow-up on clinical quality audits according to regional compliance regulations, guidance, contracts, and quality agreements.
Ensure appropriate escalation to responsible management for critical audit findings and support.
Provide education and guidance on audit processes and activities.
Manage audit reports, findings, and CAPAs in Veeva Quality Management System (QMS) and review and approve finding responses and actions in system.
Develop and monitor audit finding response and CAPA timeliness performance metrics and present trends and improvement plans to senior management.
Partner with departments across organizations to ensure consistent implementation and execution of audit program.
Work independently with respect to decision making and problem solving.

Requirements

10+ years of experience in clinical quality assurance and GCP compliance.
Bachelor’s degree in Life Sciences, Engineering, or a related field required; CQA certification is preferred.
Strong knowledge and application of Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and Good Clinical Laboratory Practice (GCLP).
Ability to travel up to 40%-60% of time.
Experience conducting audits of vendors and investigative sites.
Excellent organizational, written, verbal, and presentation communication skills, including audit report writing, presentation, and defense of findings.
Experience in inspection readiness and preparation.
Experience hosting and interacting with regulatory authorities.
Critical thinking and prioritization skills.
Experience managing and being accountable for vendors/contractors and their deliverables.
Proven ability to lead cross-functional teams and drive continuous improvement.
Proven track record and experience in supporting regulatory inspections (FDA, EMA).

Benefits

99% of the premium paid for medical, dental and vision plans.
Company-paid life insurance.
AD&D benefits.
Disability benefits.
Voluntary plans to personalize your coverage.
401(k) matching up to 6% on eligible contributions.
Long-term stock incentives.
Employee Stock Purchase Program (ESPP).
Discretionary quarterly bonus.
Flexible wellness benefit.
Generous PTO.
Paid holidays.
Company-wide shutdowns.

Applicant Tracking System Keywords

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

Hard Skills & Tools

clinical quality assuranceGCP complianceaudit strategyaudit managementCAPA managementVeeva Quality Management Systemaudit report writinginspection readinessregulatory inspectionsvendor management

Soft Skills

organizational skillscommunication skillscritical thinkingprioritization skillsproblem solvingleadershipcross-functional team collaborationpresentation skillsdecision makingeducation and guidance

Certifications

CQA certification