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Langham Logistics · 1 month ago

Quality Manager - Life Science Division

Plainfield, IN

Full-time

Onsite

Senior Level, Lead/Staff

8+ years exp

Langham Logistics is a company specializing in the life science/pharmaceutical sector, and they are seeking a Quality Manager to lead their quality unit. The role involves overseeing quality measures, managing audits, and ensuring compliance with regulatory standards while fostering a quality culture within the organization.

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Responsibilities

Oversees Quality Indicators 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 Operations Management, 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)

Facilitates Achievement of Operations and Quality Performance Expectations Provides Langham leadership with updates on quality measures and performance for the overall warehouse and distribution operations in Whiteland

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

Maintains Customer Expectations 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

Manages Performance and Systems Reporting Reviews performance metrics to ensure operations personnel adhere to company and client standards, policies, procedures, and defined goals

Reviews and analyzes quality metrics to identify recommendations for operational improvements on a continual basis

Qualification

GMP/GDP PracticesQuality ManagementRegulatory UnderstandingAnalytical SkillsLeadershipProactivenessCommunicationTeamwork

Required

8-10 years' experience in quality management in pharmaceutical/medical device manufacturing

Strong leadership characteristics and ability to lead in an operations setting is desired

Mastery of current Good Manufacturing, Good Distribution, and Good Documentation Practices (GMP/GDP), as they apply to pharmaceutical distribution operations

Strong planning and organizational skills with evidence of attention to details

Communication – ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner

Analytical Skills – ability to thoughtfully analyze a wide variety of information and data to make very key decision regarding potential risks associated with product quality or regulatory violations

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

Proactiveness – ability to anticipate potential problems and risks related to commercial product operations, investigate solutions and implement preventative actions

Regulatory Understanding – broad based knowledge of domestic and general knowledge of international regulations (ex: US. FDA 21 CFR part 11, 205, 211, EudraLex Vol. 4 cGMP, European Commission GDP Guidelines, USP standards, etc.)

Demonstrated teamwork, initiative, and problem-solving skills

Strong analytical, planning and organizational skills with evidence of attention to details