Quality Manager - Life Science Division

Job Title
:
Quality Manager – Life Science Division

Company
:
Langham Logistics

Location
:
Indianapolis, IN

Salary
: $–$

Posted
: 3 weeks ago

The Quality Manager leads the quality unit of a life science/pharmaceutical warehouse and distribution facility. They are the primary authority for all decisions affecting quality aspects of the operations, including processes, policies, work instructions, and practices. They interface directly with the respective quality counterparts of all clients serviced, drive the quality culture, establish policies and procedures, oversee implementation of learning management tools, and act as liaison for regulatory agency interactions, ensuring compliance with client quality standards for pharmaceutical distribution operations.

• Drive the development of quality culture, strategy, policy, warehouse team objectives and overall processes affecting Quality Assurance in conjunction with clients.
• Interpret and apply applicable GxP regulations/policies to complex issues.
• Manage internal and external routine and non‑routine audits/assessments and quality projects related to regulatory inspections and potential non‑compliance observations.
• In partnership with Operations Management, manage resources, priorities, schedules and projects to assure delivery of operational quality objectives.
• Lead all projects, programs or team development activities that have GxP compliance implications.
• Contribute to a quality culture environment that optimizes employee productivity and participation and adds value to the client.
• Develop warehouse operations team skill sets and knowledge base to ensure ongoing compliance with evolving regulations and client expectations.
• Direct activities of direct reports or lead matrix teams as required for effective management of the quality program.
• Engage in risk management activities to identify effective risk management strategies.
• Act as a coach, mentor or trainer to develop a passion for quality.
• Proactively identify, communicate, and monitor business/regulatory changes that could impact the quality position.
• Provide recommendations or solutions that demonstrate measurable quality improvement.
• Engage in strategic/operational decisions on behalf of the client(s).
• Provide Langham leadership with updates on quality measures and performance for overall warehouse and distribution operations.
• Prepare and present account‑level quality performance to leadership quarterly.
• Serve as new and existing account quality lead for new clients with analysis on quality programs.
• Manage and coordinate quality audits and inspections.
• Represent Langham Logistics at customer meetings and quarterly business reviews.
• Monitor CQA's and CPP's continually and recommend revised policies and procedures.
• Serve as point of contact for client quality requests including reporting, investigations, training updates, inspections and CAPA's.
• Facilitate response to routine and non‑routine client requests for data, reporting, support, problem resolution and other initiatives.
• Review performance metrics to ensure adherence to standards and goals.
• Analyze quality metrics to recommend operational improvements.

• Strong leadership characteristics in an operations setting.
• Mastery of GMP, GDP, and GDS practices for pharmaceutical distribution operations.
• Strong planning and organizational skills, attention to detail.
• Communication: persuasive verbal and written, Spanish fluency considered a plus.
• Analytical skills to assess risks related to product quality or regulatory violations.
• Teamwork: build professional relationships and collaborate cross‑functionally.
• Proactiveness: anticipate problems, investigate solutions, implement preventive actions.
• Regulatory Understanding of domestic and international regulations (e.g., US FDA 21 CFR part 11, 205, 211, Eudra Lex, EU GDP Guidelines, USP standards).

• 8–10 years’ experience in quality management in pharmaceutical/medical device manufacturing.
• Bachelor’s Degree in Biochemistry, Chemistry, Biology, or other STEM field preferred.
• Demonstrated teamwork, initiative, and problem‑solving skills.
• Strong analytical, planning and organizational skills with attention to detail.
• Mastery of GMP, GDP, and GDS practices for pharmaceutical distribution operations.

Physical movements including bending, stooping, and lifting up to 50 pounds, working on concrete in a warehouse environment with heat and cold exposure.

• Seniority level
  :
  Mid‑Senior level
• Employment type
  :
  Full‑time
• Job function
  :
  Quality Assurance
• Industries
  :
  Consumer Services

This job description is not intended to be all‑inclusive. Additional duties may be assigned. Langham reserves the right to modify responsibilities as business demands evolve.