MEDVACON LIFE SCIENCES, LLC · 16 hours ago
Senior GMP Auditor
United States
Full-time
Remote
Senior Level, Lead/Staff
$90/hr - $100/hr
15+ years expMEDVACON LIFE SCIENCES, LLC is seeking a highly experienced Senior GMP Auditor with expertise in pharmaceutical manufacturing and clinical packaging operations. The role involves conducting comprehensive audits of CDMO facilities, focusing on quality systems and GMP compliance to support clinical trial material supply.
ConsultingHuman ResourcesLife ScienceQuality Assurance
Responsibilities
Plan, lead, and execute a full scope GMP audit of the CDMO manufacturing and clinical packaging site
Evaluate the design, implementation, and effectiveness of core quality systems, including deviation management, investigations, CAPA, change control, complaint handling, batch record management, and document control
Review training systems for operations, quality, and support personnel, with attention to role-based qualification and ongoing GMP training
Assess data integrity and data governance practices across paper and electronic systems that support manufacturing, testing, and release
Perform a detailed audit of clinical packaging operations, including labeling, kitting, packaging component controls, storage conditions, and distribution interfaces
Evaluate control of printing, reconciliation, and verification activities for labels and patient specific or blinded clinical supplies
Review environmental monitoring, temperature and humidity controls, and segregation practices for clinical trial materials
Confirm that packaging, labeling, and associated documentation provide adequate control to support complex clinical trial designs, randomization schemes, and blinding requirements
Assess the overall maturity and effectiveness of the site quality management system, including governance, quality metrics, and management review
Review supplier and service provider qualification processes relevant to manufacturing and clinical packaging
Evaluate investigation quality, root cause analysis, and effectiveness checks for deviations and complaints related to packaging and manufacturing
Identify compliance gaps, systemic weaknesses, and areas where risk to product quality or patient safety may exist
Prepare a clear, detailed written audit report that documents observations, evidence, and associated risk levels
Provide practical, prioritized recommendations for corrective and preventive actions that align with GMP expectations
Present key findings and risk themes to site leadership and client stakeholders in a professional, objective manner
Support follow up discussions related to remediation plans, timelines, and verification of effectiveness, as requested
Qualification
Required
Minimum of fifteen years of GMP experience in pharmaceutical manufacturing, clinical packaging, or quality assurance, with significant time spent in auditing roles
Demonstrated experience conducting comprehensive audits of manufacturing and clinical packaging operations at CDMO or large pharmaceutical sites
Strong working knowledge of United States FDA regulations, ICH guidelines, and current industry expectations for clinical trial material manufacturing and packaging
Deep familiarity with quality systems that support clinical packaging, including label control, reconciliation, randomization support, chain of custody, and documentation practices
Proven ability to independently evaluate the maturity and robustness of complex quality systems and to distinguish between isolated issues and systemic risks
Excellent written and verbal communication skills, with a track record of producing clear, defensible audit reports and communicating with senior stakeholders
Ability to travel to and work on site at the CDMO facility in the United States
Strong professional presence, objectivity, and sound judgment when interacting with site leadership and functional teams
Ability to manage the audit scope and timeline efficiently while maintaining depth and quality of assessment
Company
MEDVACON LIFE SCIENCES, LLC
MEDVACON is a globally recognized company offering tailored FDA Quality Compliance and Technical Consulting Services.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Raymond Roggero
Managing Partner
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