Life Sciences Quality Manager

The Langham Logistics Life Sciences Services Quality Manager impacts the organization by leading the quality unit of life science warehouses and distribution facilities and acting as the primary authority for all decisions affecting quality aspects of the operations, including processes, policies, work instructions, and implemented practices.

The Quality Manager will interface directly with the respective quality counterparts of all clients serviced. This position drives the quality culture, establishes policies and procedures, oversees implementation of learning management tools, and acts as the liaison for all regulatory agency interactions on behalf of Langham Life Sciences and in compliance with client quality standards for pharmaceutical distribution operations.

This position oversees the Quality Specialist personnel and is accountable for all quality measures of performance for the operations.

Represent Langham Logistics:

1. Provide courteous, professional service to both internal and external customers.
2. Present a positive image of Langham.

Performance will be evaluated based on meeting the requirements of the job description; meeting performance metrics and other quality indicators established for this position; working according to specifications, policies, and standards established by Langham; working effectively in a team environment; and providing a high level of internal and external client service.

The Quality Associate is expected to operate according to all safety and security guidelines.

Performance metrics for this position will be established annually based on quality of work, productivity, and attendance.

• Drives the development of quality culture, strategy, policy, warehouse team objectives, and overall processes affecting Quality Assurance in conjunction with clients.
• Interprets and applies applicable GxP regulations and policies to unique and often complex issues.
• Manages internal and external, routine and non-routine audits and assessments, as well as quality projects related to regulatory inspections and potential non-compliance observations.
• In partnership with the Operations Manager, manages resources, priorities, schedules, and projects to assure delivery of the operational quality objectives.
• Leads all projects, programs, or team development activities that have GxP compliance implications.
• Contributes to a quality culture environment that optimizes employee productivity and participation and adds value to the client.
• Develops warehouse operations team skill sets and knowledge base to ensure ongoing compliance with evolving regulations and expectations for quality performance from client organizations.
• Directs the activities of one or more direct reports and/or leads a matrix team or business processes, as required for effective management of the quality program.
• Actively engages in risk management activities to identify effective risk management strategies, including the escalation of risks and their solutions.
• Acts as a coach, mentor, or trainer to develop a passion for quality in others.
• Proactively identifies, communicates, and monitors business and regulatory changes that could impact the quality position of warehouse operations.
• Provides suitable recommendations and mutual solutions that show measurable quality improvement and added value to internal and external customers.
• Engages with the business in strategic and operational decisions on behalf of clients.

Facilitates Achievement of Operations and Quality Performance Expectations

1. Provides Langham leadership with updates on quality measures and performance for the overall warehouse and distribution operations in Whiteland, Indiana.
2. Prepares and presents account-level quality performance to Langham leadership on a quarterly basis.
3. Acts as new and existing account quality lead on behalf of Langham Logistics, with responsibility for providing new clients with in-depth analysis on quality programs and metrics available through Langham Logistics business out of the Whiteland location.
4. Manages and coordinates quality audits and inspections.

Maintains Customer Expectations

1. Represents Langham Logistics at customer meetings and quarterly business reviews to provide information and updates on quality performance of the operations.
2. Continually monitors CQAs and CPPs of the operations and makes recommendations on revised policies and procedures in order to maintain world-class quality performance.
3. Serves as the point of contact for client quality requests, including reporting, investigations, training updates, inspections, and CAPAs.
4. Facilitates exceptional response to routine and non-routine client requests for data, fulfillment, reporting, customer service support, problem resolution and investigations, and other operational or quality initiatives.

Manages Performance and Systems Reporting

1. Reviews performance metrics to ensure operations personnel adhere to company and client standards, policies, procedures, and defined goals.
2. Reviews and analyzes quality metrics to identify recommendations for operational improvements on a continual basis.

1. Strong leadership characteristics and the ability to lead in an operations setting is desired.
2. Mastery of current Good Manufacturing, Good Distribution, and Good Documentation Practices (GMP/GDP) as they apply to pharmaceutical distribution operations.
3. Strong planning and organizational skills with evidence of attention to detail.
4. Communication: ability to communicate ideas and data both verbally and in writing in a persuasive and appropriate manner. Spanish fluency will be considered a plus.
5. Analytical skills: ability to thoughtfully analyze a wide variety of information and data to make key decisions regarding potential risks associated with product quality or regulatory violations.
6. Teamwork: ability to establish professional relationships and rapport with internal and external peers and higher-level management; must be able to work as part of a cross-functional, interdisciplinary team to achieve goals.
7. Proactiveness: ability to anticipate potential problems and risks related to commercial product operations, investigate solutions, and implement preventive actions.
8. Regulatory understanding: broad-based knowledge of domestic regulations and general knowledge of international regulations, such as U.S. FDA 21 CFR Parts 11, 205, and 211; EudraLex Volume 4 cGMP; European Commission GDP Guidelines; and USP standards.

Work is performed in a warehouse, office, and external environment with multiple zones of varying temperature: frozen, refrigerated, controlled room temperature, and environmental.

Work is also performed in a warehouse environment subject to temperature variances.

1. Bachelor's degree in Biochemistry, Chemistry, Biology, or another STEM field preferred.
2. 7–10 years of experience in Quality Operations or a related field within a GMP facility.

• Physical movements include bending, stooping, and lifting up to 50 pounds as part of the daily work routine. Work may be performed on concrete in a warehouse environment subject to heat and cold.