Quality Manager - Life Science Division

Job Description

Job Description

The Langham Logistics Life Sciences Quality Manager impacts the organization by leading the quality team at our Whiteland, Indiana warehouse and distribution facility 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 from the Whiteland, Indiana 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 pharmaceutical distribution operations. The position oversees other Quality personnel and is accountable for all quality measures of performance for the operations.

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

Maintains Customer Expectations

Manages Performance and Systems Reporting

Qualifications :

Skills required :