Sr. Manager, GxP Auditor (GCP & GMP)

Responsibilities

• 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

Qualifications

• 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

Preferred Qualifications:

• Experience in quality management within a GxP-regulated environment

• Experience supporting cell and/or gene therapy products

• Strong strategic thinking and project management skills

• Direct experience leading or participating in regulatory inspections

• Demonstrated ability to develop executive-level presentations and analyze complex datasets

The national base salary range for this position is $155K-$180K annually. This salary range is an estimate of what we reasonably expect to pay for this position, and the actual salary may vary based on various factors that may include but are not limited to quality and length of experience, education, geographic location and alignment with market data. This position is also eligible for bonus, benefits, and participation in the company’s stock plan.