Quality System Manager Jobs in Fishers, IN (NOW HIRING)

**This is a 2nd shift position**

The Quality Supervisor is responsible for leading daily quality operations in the Raw Material Warehouse and Sampling Suite, ensuring compliance with GMP, regulatory agencies, and client-specific requirements. This role oversees a team of Quality Associates engaged in receiving, inspecting, sampling, and testing raw materials and components while maintaining strict adherence to regulatory standards and internal procedures. The Associate Manager ensures that cleanroom and sampling activities are performed under controlled conditions, safeguarding product integrity and preventing cross-contamination.

In addition to managing team performance and workforce planning, the Quality Supervisor serves as a key liaison between Quality, Warehouse, and Operations, facilitating timely resolution of material quality issues, deviations, and client inquiries. This position supports audits, continuous improvement initiatives, and cross-functional projects to strengthen compliance and operational efficiency.

The role embodies Langham Logistics’ core values—teamwork, accountability, integrity, communication, and respect—while providing professional service to internal and external partners. The Quality Supervisor also ensures that all activities comply with safety, security, and regulatory requirements, including those related to hazardous materials, Department of Homeland Security (DHS), and Food and Drug Administration (FDA) guidelines.

• Leadership & Team Development
  Lead, mentor, and develop a team of Quality Associates working in the Raw Material Sample Suite.
  Promote a culture of compliance, accountability, and continuous improvement.
• GMP Compliance & Oversight
  Ensure all sampling, inspection, and testing activities comply with GMP, FDA, and client requirements.
  Maintain oversight of cleanroom operations, including gowning, trafficking, cleaning, environmental monitoring, and contamination control.
• Quality Systems Management
  Manage and support quality system processes including deviations, CAPA, change control, investigations, and training related to the Sample Suite.
  Review and approve quality records, ensuring completeness, accuracy, and regulatory compliance.
• Material Quality Control
  Oversee quality checks for incoming raw materials and sampling processes to ensure product integrity and traceability.
  Collaborate with Warehouse and Operations to resolve material discrepancies and quality-related issues.
• Audit Readiness & Client Support
  Serve as the primary quality contact for internal and external audits and inspections related to the Sample Suite.
  Ensure timely and accurate communication with clients regarding quality issues in alignment with SOPs and Quality Agreements.

• Continuous Improvement & Risk Management
  Identify process gaps and lead initiatives to enhance operational efficiency and regulatory compliance.
  Conduct risk assessments to support decision-making and ensure robust quality oversight.
• Safety & Security
  Ensure all activities comply with safety protocols and hazardous material handling guidelines.
  Adhere to security requirements mandated by the Department of Homeland Security (DHS), FDA, and other regulatory authorities.

The Quality Supervisor is expected to:

• Work according to Langham Logistics company values, policies and procedures
• Ensure delivery of quality objectives in partnership with management through resource management, prioritization, schedules and/or projects.
• Ensure raw material sampling and inspection activities are completed accurately, on schedule, and in compliance with GMP requirements.
• Provide oversight and maintenance of quality systems
• Maintain a state of inspection readiness.
• Plan and allocate daily manpower, schedules, and instructions to ensure timely completion of sampling, inspection, and quality control activities in alignment with client and operational priorities.
• Assign daily tasks based on individual team member skills (e.g., gowning, sampling, environmental monitoring, inspection, documentation, or material checks).
• Accept or reject raw materials based on quality, regulatory, and client-specific standards.
• Physically verify incoming and outgoing raw materials for damage, discrepancies, and compliance with specifications.
• Crosstrain Quality Associates to ensure operational flexibility and coverage across all suite functions.
• Maximize efficiency through proper use of systems and tools (e.g., LIMS, Raman, calipers, Go / No Go gauges, where applicable).
• Ensure all team activities comply with Langham policies, SOPs, GMP requirements, and safety standards.
• Provide coaching, guidance, and support to employees, assisting with work process challenges and reinforcing adherence to compliance expectations.

• Strong understanding of current Good Manufacturing, Good Distribution, and Good Documentation Practices (GMP/GDP), as they apply to raw materials and pharmaceutical distribution operations.
• Proficient computer skills, including Microsoft Office.
• Planning and organizational skills to manage dynamic environment with shifting priorities.
• Decision Making – ability to assess situations, evaluate risks, and implement effective & compliant solutions in a GMP environment.
• Communication – ability to effectively communicate to internal and external teams both verbally and written in an appropriate manner.
• Analytical Skills – ability to thoughtfully analyze a wide variety of information and data to make key decisions regarding potential risks associated with product quality.
• Teamwork – ability to establish professional relationships and rapport with internal and external peers and management.
• Proactiveness – ability to anticipate potential problems and risks related to product, operations, and investigate solutions.
• Organization – ability to manage multiple quality records with various due dates to ensure timely completion and maintain records in a readily retrievable format.

• Bachelor’s degree in scientific or technical discipline (e.g., Biology, Chemistry, Pharmaceutical Sciences) or equivalent experience.
• Minimum 3 years of Quality experience in GMP-regulated environment
• Strong knowledge of GMP regulations (FDA, EU, ICH)
• Previous Supervisory or Managerial experience required

Physical Demands and Work Environment: Physical movements include bending, stooping, and lifting to 50 pounds as part of daily work routine. Will work on concrete in a warehouse environment (subject to heat and cold). Work is performed in a warehouse environment subject to temperature variances.

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.