Change Control and Deviation Coordinator

The Change Control / Deviation Coordinator is responsible for managing and tracking all change control and deviation activities within a Langham Logistics supporting biologics, vaccines, and general pharmaceutical products. This role ensures that any changes to processes, equipment, or systems are properly assessed, documented, and approved, and that deviations are investigated, resolved, and reported in compliance with cGMP, GDP, and FDA regulations.

The Coordinator works closely with quality, operations, and regulatory teams to maintain product integrity, regulatory compliance, and continuous improvement.

Key Outcomes Expected

• Coordinate and manage all change control requests within the Quality Management System (QMS), ensuring proper documentation, review, and approval.
• Track and investigate deviations and non-conformances from standard operating procedures, processes, or regulatory requirements.
• Conduct root cause analysis (RCA) and assist in implementing corrective and preventive actions (CAPA).
• Ensure all change control and deviation activities comply with applicable cGMP, GDP, FDA, and ICH guidelines.
• Maintain accurate records and documentation to support audit readiness for internal, client, and regulatory inspections.
• Collaborate with operations, warehouse, and regulatory teams to assess the impact of changes or deviations on temperature-controlled products (biologics/vaccines) and general pharmaceuticals.
• Facilitate cross-functional change control review meetings and ensure timely communication of decisions.
• Monitor trends and generate reports on deviations, change control activities, and CAPA effectiveness to support management review and continuous improvement.
• Provide guidance and training to associates on deviation reporting and change control procedures.
  
  

Education And Experience

• Bachelor’s degree in Life Sciences, Quality Management, Pharmacy, or related field.
• 3–5 years of experience in quality, compliance, or regulatory roles within pharmaceutical, biotech, or 3PL logistics environments.
• Solid understanding of cGMP, GDP, FDA, and ICH guidelines.
• Experience handling temperature-sensitive biologics and vaccines preferred.
• Strong organizational, problem-solving, and analytical skills.
• Excellent written and verbal communication skills.
• Proficiency with QMS software, deviation tracking systems, and MS Office applications.
  
  

Preferred Skills

• Experience conducting root cause analysis (RCA) and managing CAPAs.
• Knowledge of cold chain management, validation protocols, and risk assessment.
• Familiarity with audit processes and regulatory inspections.
• Prior experience in pharmaceutical distribution or 3PL operations.
  
  

Physical Demands

• Physical movements including bending, stooping, and lifting up to 75 pounds as part of daily work routine.
• May be working on concrete in a warehouse environment (subject to heat and cold).
• Must be able to operate computer equipment.
  
  

Work Environment

This role operates in a regulated warehouse and office environment, including areas requiring temperature-controlled storage. Occasional travel may be required for audits, training, or client meetings.

Disclaimer

This job description is not intended to be all-inclusive. This position may be required to perform other related duties assigned to meet the ongoing needs of the organization. Langham reserves the right to modify job responsibilities and expectations as business demands evolve.

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