Lead Site Auditor

* 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
* 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 technical knowledge in areas pertaining to the hiring site (e.g, Quality Systems, Manufacturing, Testing/Stability, Microbiology testing, Packaging, Distribution, Data Integrity, Automation)
* Knowledge of QBD development & submission requirements, as applicable to site
* Ability to lead, motivate, develop and mentor other auditors
* Knowledge of and experience in Quality Risk Management methods
* Knowledge of US and European cGMP guidelines, ICH and other international regulatory requirements, as applicable
* Experience with hosting or participating in Health Authority inspections and/or Divisional audits
* Highly motivated, flexible, and have excellent organizational and communication skills
* Excellent verbal and written communication skills
* Ability to prioritize and balance work from multiple projects in parallel
** Los Angeles Residents Only:
** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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