Langham Logistics · 2 months ago
Quality Manager - Life Science Division
Whitestown, IN
Full-time
Onsite
Senior Level
7+ years expLangham Logistics is focused on providing quality services in the life sciences sector, and they are seeking a Quality Manager to lead the quality unit for their warehouses and distribution facilities. The role involves driving the quality culture, overseeing compliance with regulations, and managing quality measures of performance for operations.
AutomotiveTransportation
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 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 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
Act 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 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
Manage and coordinate quality audits and inspections
Represents Langham Logistics at customer meetings and quarterly business reviews to provide information and updates on quality performance of the operations
Continually monitors CQA's and CPP's of the operations and makes recommendations on revised policies and procedures in order to maintain world class quality performance
Serves as the point of contact for client quality requests including reporting, investigations, training updates, inspections and CAPA's
Facilitates exceptional response to routine and non-routine client requests for data, fulfilment, reporting, customer service support, problem resolution/investigations, and other operational or quality initiatives
Qualification
Required
7-10 years' experience in Pharmaceutical and/or Life Science Quality Operations
Bachelor's Degree in Biochemistry, Chemistry, Biology, or other STEM field
Company
Langham Logistics
Langham Logistics is a logistics company offering supply chain management services.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Tracy Jaisle
Chief Financial Officer
Brian Landrum
Chief Operating Officer
Recent News
Indianapolis Business Journal
2023-12-26
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