Lead Site Auditor

Job Description

The Quality Associate Director/GMP Lead Site Auditor will have leadership responsibility for the site internal audit program, encompassing the full scope of site operations. Collaboration is required with site leadership, regional compliance leadership and Divisional Quality Assurance to elevate the site audit program to achieve excellence and ensure the program is effective. The position requires ability to lead and perform the operational aspects of the audit program, apply risk‑based principles, communicate results to stakeholders, and evaluate/verify CAPA closure.

Position requires risk communication related to the totality of audit and inspection findings at the site. Ability to lead an audit program that is focused on early detection and robust remediation of observation across the site. Ability to play a lead role in hosting Health Authority inspections and Divisional Audits at the site.

• Actively manage, mentor, and support site auditors to ensure performance of auditors contributes to the effectiveness of the site audit program
• Function as a change agent related to culture and audit program performance
• Lead change and process improvement initiatives related to Auditing, Inspections, CAPA, and other compliance topics
• Perform routine risk communication pertaining to audits/inspection to Site, Regional, and Divisional Management
• Mentor new auditors to ensure comprehensive training and full understanding of auditor roles and responsibilities
• Achieve and maintain auditor qualification status through robust training and continuing education
• Lead training/orientation for new Quality Auditing staff
• Ensure preparation of annual audit schedule, using risk‑based approaches
• Schedule and perform assigned audits for site program
• Ensure timelines and quality of content for audit execution (audit pre‑work, conducting audit, issuance of audit report, CAPA review and verification) meet established expectations
• Perform, lead, and mentor other auditors during site audits; participate in opportunities to audit at regional sites
• Review and approve Audit Reports
• Actively monitor, report and trend observations/CAPAs, along with standard site audit metrics to Quality Council and Management
• Actively participate and take a leadership role in the Auditor Community of Practice and Guest Auditor Program
• Review and ensure CAPA responses to Audits and Inspections are robust
• Perform a risk‑based verification and effectiveness check on key CAPAs from audits and inspections
• Recommend and lead implementation of improvements to the Audit and Inspection Management programs based on new regulations, guidance documents, and industry standards
• Lead company and site preparation activities for support of regulatory and customer inspections
• Provide compliance advice to site, development and commercial product teams
• Supports and continually enhance the ongoing site Permanent Inspection Readiness status
• Obtain and maintain cutting‑edge knowledge and auditing techniques across applicable technical/Quality topics

• Bachelor's degree in engineering, Biology, Chemistry or related field

• Minimum of five (5) years of manufacturing, technology, laboratory, and/or quality operations experience within GMP environment
• GMP Compliance knowledge and proficiency in interpreting and applying domestic and international regulatory requirements
• Knowledge of Quality Systems within a GMP environment
• Demonstrated ability to establish and maintain collaborative relationships with key stakeholders
• Ability to work independently with limited supervision
• Ability to build relationships and influence across disciplines and all levels

• GMP Audit experience in the pharmaceutical industry (CQA or other certification preferred)
• Experience with leading effective audits and obtaining meaningful audit observations
• “Subject Matter Expertise”, including knowledge and demonstrated application in one or more of the following areas, based on site activities;
  Medical Device/Combination products, Biologics, Vaccines, API's or Non Sterile or Sterile Drug Product
• Specific…