Lead Site Auditor

Merck•Durham, NC

8h•Hybrid

About The Position

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 site audit program to achieve excellence and ensure 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.

Requirements

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
Accountability
Accountability
Aseptic Processing
Audit Management
Biological Sciences
cGMP Training
Customer-Focused
Detail-Oriented
Driving Continuous Improvement
Ethical Standards
GMP Compliance
Immunochemistry
Internal Auditing
IS Audit
Management Process
Medical Devices
Molecular Microbiology
Quality Auditing
Quality Control Documentation
Quality Control Management
Quality Management Systems (QMS)
Quality Metrics
Quality Risk Assessment
Quality Risk Management
Regulatory Compliance Consulting

Nice To Haves

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

Responsibilities

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