Senior GMP Auditor

Medvacon Life Sciences•Sparta, NJ

12d•Remote

About The Position

Our organization is seeking a highly experienced Senior GMP Auditor with deep expertise in pharmaceutical manufacturing and clinical packaging operations. This role will perform a comprehensive, independent audit of a CDMO manufacturing and clinical packaging facility located in the United States. The auditor will focus on the strength and effectiveness of key quality systems, clinical packaging and labeling controls, and overall GMP compliance that supports clinical trial material supply.

Requirements

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.

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.