Lead and execute internal audits across GMP, GCP, and GPV systems and associated functions, ensuring timely follow-up through CAPA implementation
Conduct GxP audits in accordance with applicable regulatory requirements, including preparation of detailed audit reports and oversight of corrective and preventive actions
Apply strong knowledge of clinical and CMC development processes to manage and continuously improve the internal GxP audit program
Independently manage multiple priorities, solve complex problems, and maintain a high level of inspection readiness
Support external audits and regulatory inspections, partnering closely with cross-functional teams
Represent Quality Vendor Management in cross-functional meetings, contributing to aligned and compliant decision-making
Oversee the GxP vendor and supplier management program to ensure compliance with regulatory standards and internal requirements
Perform risk assessments and drive continuous improvement initiatives to strengthen quality and compliance frameworks
Author, review, and update SOPs to ensure alignment with evolving regulatory expectations and business needs
Develop and implement tools and processes to enhance audit consistency, efficiency, and overall compliance
Support inspection readiness activities and collaborate with stakeholders to ensure organizational preparedness
Ensure supplier management processes, including qualification and ongoing oversight, are executed in accordance with SOPs and KPIs
Support the development and maintenance of Quality Agreements and supplier contracts as needed
Escalate critical findings to appropriate management and ensure timely and effective resolution in line with company procedures
Lead the development and monitoring of supplier performance metrics to proactively identify risks and mitigate compliance issues
Maintain and manage the approved supplier list to ensure accuracy and compliance

Requirements

ASQ Certified Quality Auditor (CQA) or equivalent certification required
BA/BS in Biological Sciences, Chemistry, or a related field, or equivalent combination of education and experience
Minimum of 10+ years of experience in the pharmaceutical or biotechnology industry, including at least 5+ years in GMP, GCP, and/or GVP auditing
Strong working knowledge of GMP, GCP, GPV, and GLP regulations across U.S. and EU frameworks, including ICH guidelines
Demonstrated leadership capabilities with experience in people management and development
Excellent written and verbal communication skills, with strong organizational abilities
Willingness and ability to travel up to 25% to support audit activities
Proven ability to operate effectively in a fast-paced, high-growth environment with evolving priorities
Hands-on experience with Quality Systems and electronic databases (e.g., eQMS platforms) and clinical systems such as Veeva Vault/RIM, ARGUS, and Medidata
Proficiency in Microsoft Office Suite, including Excel, Outlook, PowerPoint, and Word

Benefits

Bonus
Benefits
Participation in the company’s stock plan

Applicant Tracking System Keywords

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

Hard Skills & Tools

GMPGCPGPVGLPauditingrisk assessmentsCAPA implementationSOP authoringquality complianceclinical development processes

Soft Skills

leadershipproblem-solvingorganizational abilitiescommunication skillscross-functional collaborationinspection readinesstime managementdecision-makingcontinuous improvementpeople management

Certifications

ASQ Certified Quality Auditor (CQA)