Quality Manager - Life Science Division

About the role

The Quality Manager leads the quality unit of life science warehouses and distribution facilities, acting as the primary authority for all decisions affecting quality aspects of operations, including processes, policies, work instructions, and implemented practices. This position interfaces directly with quality counterparts of all clients serviced, drives quality culture, establishes policies and procedures, oversees learning management tools, and serves as the liaison for regulatory agency interactions on behalf of Langham Life Sciences.

Responsibilities

• 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/policies to unique and often complex issues.
• Manages internal and external, routine and non-routine audits/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/or projects to assure delivery of 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 the client(s).
• 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/regulatory changes that could impact the quality position of the warehouse operations.
• Provides suitable recommendations/mutual solutions that show measurable quality improvement and added value to internal/external customers.
• Engages with the business in strategic/operational decisions on behalf of the client(s).
• Provides Langham leadership with updates on quality measures and performance for the overall warehouse and distribution operations in Whiteland, IN.
• Prepares and presents account-level quality performance to Langham leadership on a quarterly basis.
• Acts as new and existing account quality lead on behalf of Langham Logistics, providing new clients with in-depth analysis on quality programs and metrics.
• Manages and coordinates quality audits and inspections.
• Represents Langham Logistics at customer meetings and quarterly business reviews to provide updates on quality performance.
• Continually monitors Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) of operations and recommends revised policies and procedures to maintain world-class quality performance.
• Serves as the point of contact for client quality requests, including reporting, investigations, training updates, inspections, and CAPAs.
• Facilitates exceptional response to routine and non-routine client requests for data, fulfillment, reporting, customer service support, problem resolution/investigations, and other operational or quality initiatives.

Requirements

• Bachelor’s Degree in Biochemistry, Chemistry, Biology, or other STEM field preferred.
• 7-10 years’ experience in Pharmaceutical and/or Life Science Quality Operations.

Physical Demands

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

Work Environment

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