Quality Manager - Life Science Division

Job Description

Job Description

Quality Manager impacts the organization by leading the quality unit of life science warehouses and distribution facilities 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. This position 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.

This position oversees the Quality Specialist personnel and is accountable for all quality measures of performance for the operations.

Key Outcomes Expected

• 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).

Quality Performance Expectations

Maintains Customer Expectations

Education and Experience

Physical Demands

Physical movements including bending, stooping, and lifting up to 50 pounds as part of daily work routine. Will be working on concrete in a warehouse environment (subject to heat and cold).

Work Environment

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

Disclaimer

This job description is not intended to be all-inclusive. This position may be required to perform other related duties assigned to meet the ongoing needs of the organization. Langham reserves the right to modify job responsibilities and expectations as business demands evolve.

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