Quality Manager - Life Science Division

The Quality Manager leads the quality unit of a life science/pharmaceutical warehouse and distribution facility, 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

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.
  
  

Critical Skills and Knowledge

• 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. Spanish fluency will be considered a plus.
• 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.).
  
  

Education and Experience

• 8-10 years’ experience in quality management in pharmaceutical/medical device manufacturing.
• Bachelor's Degree in Biochemistry, Chemistry, Biology, or other STEM field preferred.
• 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 pharmaceutical distribution operations.
  
  

Physical Demands and Work Environment: 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 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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