The Quality Manager will interface directly with the respective quality counterparts of all clients serviced from the Whiteland, IN location. He/She 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 the client quality standards for medical distribution operations.
The position oversees the Quality Specialist personnel and is accountable for all quality measures of performance for the operations. Job Duties: 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 Gx P regulations/policies to unique and often complex issues.
Manages internal and external, routine and non-routine audits backssments 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 Gx P 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 Whitestown. 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 Whitestown 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. Critical Skills, Knowledge & Behaviors: People Management - ability to lead a team of associates in a warehouse environment to ensure adherance to KPIs 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 key decisions 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 Proactiveness – ability to anticipate potential problems and risks related to commercial product operations, investigate solutions, and implement preventive actions. Regulatory Understanding – broad based knowledge of domestic and general knowledge of international regulations (e. g. U. S. FDA 21 CFR Part 11, 205, 211, Eudra Lex Vol. 4 c GMP, European Commission GDP Guidelines, USP standards, etc.
). Education/Experience: Bachelor's Degree in Biochemistry, Chemistry, Biology, or other STEM field preferred. Strong leadership characteristics and ability to lead a team in an operations setting is desired. Demonstrated teamwork, initiative, and problem-solving skills. Strong analytical, planning and organizational skills with evidence of attention to details. Mastery of current Good Manufacturing, Good Distribution, and Good Documentation Practices, as they apply to medical distribution operations. Good Communication and Interpersonal Skills a must. Must be able to work as part of a cross functional, interdisciplinary team in order to achieve goals.
Physical Demands/Work Environment Work is performed in a warehouse/office environment with multiple zones of varying temperature. Physical movements include bending, lifting up to 50 lbs as part of daily work. Keywords: STEM, Quality Management
