Quality Manager - Life Science Division

Langham Logistics, Inc•Whitestown, IN

2d•Onsite

About The Position

The Quality Manager for Langham Logistics’ Life Sciences division leads the quality team at the Whiteland, Indiana warehouse and distribution facility and serves as the primary authority for decisions affecting operational quality, including processes, policies, work instructions, and implemented practices. The role interfaces directly with quality counterparts at clients served from the location and drives the quality culture, establishes policies and procedures, oversees learning management tools, and serves as liaison for regulatory agency interactions on behalf of Langham Life Sciences. The position ensures compliance with client quality standards for pharmaceutical distribution operations, oversees other Quality personnel, and is accountable for operational quality performance measures. The Quality Manager develops quality strategy and procedures with clients, interprets applicable GxP requirements, manages audits and assessments, and partners with Operations Management to align resources and priorities with operational quality objectives. The role leads GxP-related projects and team development, supports risk management, develops employee capabilities, and monitors regulatory and business changes that could affect warehouse quality. It also provides quality performance updates to leadership and clients, manages customer quality requests and inspections, and analyzes metrics to recommend continual operational improvements.

Requirements

5–7 years of experience in quality management in logistics or pharmaceutical/medical device manufacturing.
Demonstrated teamwork, initiative, and problem-solving skills.
Strong analytical, planning, and organizational skills, with attention to detail.
Mastery of current Good Manufacturing, Good Distribution, and Good Documentation Practices as applied to pharmaceutical distribution operations.
Good communication and interpersonal skills, and ability to work on a cross-functional, interdisciplinary team.
Ability to speak and write English.
Leadership competency, including leading a team and managing others.
Ability to communicate ideas and data verbally and in writing in a persuasive and appropriate manner.
Ability to analyze varied information and data to make decisions about risks related to product quality or regulatory violations.
Ability to build professional relationships with internal and external peers and higher-level management.
Ability to anticipate commercial product operations problems and risks, investigate solutions, and implement preventive actions.
Broad knowledge of domestic regulations and general knowledge of international regulations, including examples such as U.S. FDA 21 CFR Parts 11, 205, and 211; EudraLex Volume 4 cGMP; European Commission GDP Guidelines; and USP standards.

Nice To Haves

Bachelor’s degree in Biochemistry, Chemistry, Biology, or another STEM field preferred.
Spanish fluency is a plus.
Strong leadership characteristics and ability to lead in an operations setting are desired.

Responsibilities

Lead the quality team at the Whiteland warehouse and distribution facility and oversee other Quality personnel.
Serve as the primary authority for operational quality decisions, including processes, policies, work instructions, and practices.
Develop quality culture, strategy, policies, warehouse objectives, and quality assurance processes in conjunction with clients.
Interpret and apply applicable GxP regulations and policies to operational issues.
Manage internal and external, routine and non-routine audits and assessments, and quality projects related to inspections and potential non-compliance observations.
Partner with Operations Management to manage resources, priorities, schedules, and projects supporting operational quality objectives.
Lead projects, programs, and team development activities with GxP compliance implications.
Develop warehouse team skills and knowledge to support ongoing compliance with evolving regulations and client quality expectations.
Direct direct reports and/or lead matrix teams and business processes as needed to manage the quality program.
Engage in risk management, identify risk strategies, and escalate risks and solutions.
Coach, mentor, or train others to develop a strong commitment to quality.
Monitor and communicate business and regulatory changes that could affect the quality position of warehouse operations.
Recommend solutions that deliver measurable quality improvement and value to internal and external customers.
Participate in strategic and operational business decisions on behalf of clients.
Provide Langham leadership with updates on warehouse and distribution quality measures and performance.
Prepare and present account-level quality performance to Langham leadership quarterly.
Lead quality for new and existing accounts, including providing prospective clients with analysis of available quality programs and metrics at the Whiteland location.
Manage and coordinate quality audits and inspections.
Represent Langham Logistics at customer meetings and quarterly business reviews, providing quality performance information and updates.
Monitor operational CQA's and CPP's and recommend policy and procedure revisions to maintain quality performance.
Serve as the point of contact for client quality requests, including reporting, investigations, training updates, inspections, and CAPAs.
Respond to client requests involving data, fulfillment, reporting, customer service support, problem resolution, investigations, and other operational or quality initiatives.
Review performance metrics to ensure personnel comply with company and client standards, policies, procedures, and goals.
Analyze quality metrics and recommend continual operational improvements.