Apply on Employer Site

Merck · 7 hours ago

Lead Site Auditor

Durham, NC

Full-time

Hybrid

Mid, Senior Level

$126K/yr - $199K/yr

5+ years exp

Merck is a global healthcare company committed to improving health and well-being. They are seeking a Lead Site Auditor who will oversee the site internal audit program, ensuring its effectiveness and leading initiatives for compliance and quality assurance in a GMP environment.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

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

Qualification

GMP ComplianceQuality SystemsAudit ManagementRisk ManagementGMP Audit ExperienceRegulatory ComplianceQuality Risk AssessmentDriving Continuous ImprovementCommunication SkillsDetail-OrientedCustomer-FocusedMentoring Skills

Required

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

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

Preferred

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