Manager, Clinical QC - GMP Sample Management and Testing, Analytical Development & Clinical QC

This is what you will do:

The Manager for Clinical QC (GMP) Shipping, Receiving, Sample Management, and Sample Stability is responsible for leading a team in the coordination and execution of all activities related to the shipment, receipt, management, and stability monitoring of Quality Control (QC) samples within a GMP-regulated environment with additional oversight of compendial testing. This role ensures strict adherence to GMP guidelines, regulatory requirements, and internal quality standards, supporting manufacturing operations and product release processes.

The manager provides oversight, leadership, and continuous improvement, partnering with Quality, Manufacturing, Logistics, and external vendors to ensure the secure, traceable, and compliant handling of QC samples across their lifecycle.

• Team Leadership & Training: Supervise, mentor, and develop staff engaged in GMP‑compliant QC sample shipping, receiving, storage, and stability monitoring. Ensure ongoing training and competency in GMP policies, sample handling, and documentation requirements.
• GMP Compliance: Oversee all sample management and compendial testing (Appearance, pH, Osmolarity, sub‑visible particle testing, etc.) operations to ensure complete compliance with GMP, internal SOPs, and regulatory requirements (FDA, EMA, etc.). Lead the team through internal and external audits/inspections, investigate deviations, and ensure timely implementation of CAPAs.
• Sample Shipping & Receiving: Manage and direct the shipping and receipt of Clinical QC samples/reference material, ensuring correct packaging, secure transit, accurate documentation, and compliance with environmental control (e.g., temperature) requirements. Hands‑on experience with international sample shipping, customs documentation, and regulatory requirements for global operations.
• Sample Inventory & Chain‑of‑Custody: Implement and maintain robust sample tracking and inventory systems to guarantee sample integrity, traceability, and chain‑of‑custody throughout the process. Regularly review inventory, reconcile records, and ensure proper archival or disposal of samples.
• Sample Stability Management: Oversee the management of sample stability studies, including planning, initiation, monitoring, documentation, and reporting in alignment with GMP and protocol requirements. Ensure prompt response to any storage excursions and accurate data recording for regulatory filings.
• Process Improvement & Compliance Monitoring: Identify and implement opportunities for process optimization, efficiency improvements, and risk mitigation while maintaining GMP compliance. Support digitalization, automation, and adoption of new technologies in sample logistics.
• Cross‑Functional
  
  Collaboration:
  
  Act as liaison with Quality Assurance, Manufacturing, Analytical Labs, Supply Chain, and Logistics to coordinate QC sample movement, resolve issues, and align on project timelines. Ability to effectively communicate complex technical content to diverse audiences, including regulatory bodies.
• Vendor and Resource Management: Oversee the selection and management of couriers and service providers, negotiate contracts as needed, and ensure service level agreements (SLAs) are met.
• Reporting & Documentation: Ensure accurate and timely reporting of inventory, sample disposition, stability data, and key operational KPIs. Provide data and support for regulatory submissions and product release.

• A successful candidate will have a BS Degree or Master’s degree in a scientific field (e.g., Chemistry, Biology, Pharmacy) or equivalent.
• 5+ years of experience with GMP environments and QC sample management, including proven leadership or management track record.
• Deep understanding of GMP, ICH, and country‑specific regulatory requirements related to sample handling, shipping, and stability.
• Proficiency in Laboratory Information Management Systems (LIMS), inventory tracking, and Microsoft Office Suite.
• Strong problem‑solving, organizational, and communication skills.
• Demonstrated ability to lead teams through audits and regulatory inspections.

• Lean Six…