Senior Manager, GxP Auditor – GCP, GMP

Role Overview

• 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

Tech Stack

• Google Cloud Platform
• Vault

Benefits

• Bonus
• Benefits
• Participation in the company’s stock plan