Langham Logistics · 1 month ago
Quality System and Compliance Manager
Indianapolis, IN
Full-time
Onsite
Senior Level
5+ years expLangham Logistics is a company supporting the pharmaceutical industry, and they are seeking a Quality System and Compliance Manager. This role is responsible for overseeing quality and compliance activities, ensuring operations meet regulatory requirements and maintaining audit readiness while focusing on continuous improvement of the Quality Management System.
AutomotiveTransportation
Responsibilities
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
Qualification
Required
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
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
Company
Langham Logistics
Langham Logistics is a logistics company offering supply chain management services.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Tracy Jaisle
Chief Financial Officer
Brian Landrum
Chief Operating Officer
Recent News
Indianapolis Business Journal
2023-12-26
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