Quality System and Compliance Manager

5 hours ago

Indianapolis, IN, United States Langham Logistics Full time

The Quality System and Compliance Manager is responsible for overseeing quality and compliance activities for Langham Logistics supporting the pharmaceutical industry, including biologics, vaccines, and general pharmaceutical products. This role ensures all operations meet regulatory requirements, client expectations, and company standards while maintaining a state of audit readiness.

The Manager will implement, maintain, and continuously improve the Quality Management System (QMS), with a strong focus on cGMP, GDP, and cold chain requirements for sensitive pharmaceutical products.

Key Outcomes Expected

  • Develop, implement, and maintain a compliant Quality Management System (QMS) in accordance with cGMP, GDP, FDA, and ICH guidelines.
  • Oversee document control, change management, deviation handling, CAPA, and training programs.
  • Conduct and manage internal audits, coordinate client audits, and support regulatory inspections.
  • Ensure compliance for all pharmaceutical storage, handling, and distribution activities, including cold chain logistics for biologics and vaccines.
  • Monitor and ensure the integrity of temperature-controlled shipments, including validation of storage and transportation equipment.
  • Review and Approve investigations, deviations, nonconformances, and customer complaints; root cause analysis and corrective actions.
  • Maintain quality metrics and prepare management review reports to monitor system performance.
  • Collaborate with operations, warehouse, and client service teams to ensure adherence to GDP and cold chain protocols.
  • Review and approve SOPs, validation protocols, and quality agreements.
  • Ensure all associates receive appropriate quality and compliance training.
  • Support continuous improvement initiatives to drive operational excellence and regulatory compliance.
Education and Experience
  • Bachelor's degree in Life Sciences, Quality Management, Engineering, or related field (advanced degree preferred).
  • 5+ years of experience in Quality or Compliance within pharmaceutical, biotech, or 3PL logistics environments.
  • Strong knowledge of cGMP, GDP, FDA, and ICH guidelines for both general pharmaceuticals and temperature-sensitive biologics.
  • Experience managing quality systems, audits, and regulatory inspections.
  • Proven ability to interpret and apply regulatory requirements in a logistics environment.
  • Excellent communication, leadership, and problem-solving skills.
  • Proficiency with QMS software and MS Office tools.
Preferred Skills:
  • Experience in cold chain management for biologics, vaccines, or temperature-sensitive products.
  • Knowledge of ISO 9001, ISO 13485, or other relevant standards.
  • Background in risk management, supplier quality oversight, and validation of storage/transport equipment.
  • Prior experience working with pharmaceutical clients, regulatory agencies, or clinical trial logistics.
Physical Demands and Work Environment
  • 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.
  • 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 visits.


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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