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.

You will be responsible for:

• 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.

You will need to have:

• 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.

We would prefer for you to have:

• Lean Six Sigma or Other Quality Certifications:
  Formal training or certification in Lean, Six Sigma, Kaizen, or similar methodologies for process improvement.

• Project Management Certification:
  PMP (Project Management Professional) or similar certification indicating strong project management skills.

• Experience with Digital Solutions:
  Proficiency with digital tools for sample management, automation, or laboratory digitalization (e.g., advanced LIMS, electronic batch records, barcoding solutions).

• Cold Chain Logistics Expertise:
  Specialized knowledge and experience in cold chain management, cryogenic sample handling, or temperature-controlled shipping.

• Audit and Inspection Experience:
  Direct involvement with health authority inspections (FDA, EMA, MHRA, etc.) and experience preparing responses or managing remediation activities.

• Vendor/Supplier Management:
  Experience negotiating, managing, and auditing third-party logistics providers, couriers, biorepositories, or sample storage facilities.

• Change Control and Risk Assessment Skills:
  Expertise in managing change controls, performing risk assessments (FMEA, HACCP), or driving risk mitigation projects in a GMP environment.

• Excellent Data Analytics Skills:
  Strong ability to analyze operational and quality data, interpret trends, and present findings to senior leadership.

• Experience in Biologics or Advanced Therapies:
  Background working with complex modalities such as biologics, cell and gene therapy materials, or highly potent compounds.

The annual base salary for this position ranges from $110,000 to $166,000. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.