Commercial Quality Manager

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Job Description:

The Commercial Quality position is responsible for the execution of Quality Management Systems and compliance with applicable laws and regulations at the Regional Distribution Center. The position is also responsible for executing and leading on assigned projects in RDC as well as ASIAPAC as per project scope and timeliness. The position will work closely with various internal and external stakeholders.

• Internal: Franchises, Affiliates, Regional and global function

• External: Third Party Logistic Partners where applicable

Key responsiblities :

• Oversight of process and systems related with cGMPs, Product handling and storage, quality investigations and managing partnerships with Franchises and Affiliates.

• Serve as single point of contact to internal and external partners on Distribution Quality related matters and liaise with multiple Quality organizations to drive timely resolution of Quality related issues. Identify opportunities to continuously improve quality, cost and time factors, consistent with both commercial quality function as well as Deliver Operation business objectives. Identifies significant business issues, prioritize for action, and lead improvement opportunities and problem solutions in collaboration with other Distributions Centers.

• Plans, coordinates, and directs quality assurance programs designed to ensure effective and consistent processes with established standards.

• Responsible for Quality oversight within the DC.

• Responsible for ensuring returned product is disposition according to procedures.

• Responsible for resolving discrepancies in a timely fashion with appropriate partner.

• Responsible for Quality management of repack relabel operation in the DC, management of temperature-controlled facilities ensuring compliance with monitoring of ambient environment (temperature and humidity as required) and excursions management.

• Responsible for implementation of quality system programs such as validation, CAPA, NC, IA, Document management software systems oversight.

• Responsible for compliance to change control and for oversight for compliance with training management, including operator certification.

• Responsible for oversight for monitoring of calibration and preventive maintenance systems.

• Responsible for the oversight for capture and processing of Affiliate Delivery Service Issues including tracking and trending and for management of delivery service-related issues.

• Responsible for establishing or overseeing appropriate internal-external Quality Agreements. Create, review, and approve assessment plans, risk assessment reports, non-conformance reports, corrective and preventative actions, audits, and other documentation.

• Support leadership and compliance activities including, but not limited to the creation and revisions of global and local procedures.

• Evaluate overall compliance risk, recommend corrective actions, and track progress

• Escalate all appropriate issues to Management. Responsible for conducting/support internal Quality audits of DCs (schedule, plan, conduct, and follow up

• Responsible for oversight of DC facility licenses.

• Responsible for all Health Authority inspections (e.g. HSA) and/or Notify Body conducted at the DC, including reviewing the preparation plan with on-site management.

• Responsible for the execution of DC risk evaluation

• Provides interpretation of policies and regulations to unique site requirements and problems and acts as quality representative for management initiatives.

• Makes quality decisions based upon assessments of compliance risks balanced with the overall business needs.

• Drives innovation within functional area while ensuring functional initiatives are delivered in a compliant, cost-efficient manner. Ensures that new initiatives meet customer and regulatory requirements.

• Responsible for Quality management of repacking, relabeling, over labeling, kitting, and reworking operations conducted within the DC.

• Responsible for carrying out managerial responsibilities in accordance with the organization's policies and applicable laws; including if required interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; addressing complaints; and resolving problems.

• Manager must be a strong leader to provide leadership. He/she must support the round the clock operations of the Distribution Center.

• Responsible for leading the implementation of regional initiatives like JJOS and QE2 in ASPAC region and develop the Quality Engineering capability in RDC.

• Leads, and / or contributes to, the utilization of various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode, effects analysis)

• Supports execution of strategic vision or plan by collaborating with other quality leaders to identify required Quality Engineering skills and competencies

• Act as a backup for Senior Manager Commercial Quality and in his / her absence for approvals and other quality related matters as delegate

Requirements:

• Bachelors / Master's Degree with a minimum of 8-10 years in a FDA regulated environment in a pharmaceutical / Medical Devices, distribution or quality environment is required.

• Extensive knowledge of Quality Assurance, Quality Control and Compliance is required.

Technical Skills:

• Integrity and Credo Based Actions

• Strategic Thinking

• Big Picture Orientation with Attention to Detail

• Intellectual Curiosity

• Sense of Urgency

• Results and Performance Driven

• Collaboration and Teaming

• Prudent Risk Taking

• Self-Awareness

• Adaptability

Work Experience:

• Significant experience in the development, implementation and review of SOPs is required.

• General FDA and/or DEA audit experience is preferred.