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Director of Quality
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Reference Number: MJB3884

Job Title:

Director of Quality

Summary:

Plan, direct and implement quality systems within areas of responsibility to deliver safe, quality products meeting customer requirements while ensuring that the company is in compliance with FDA and other regulatory agencies. For areas of responsibility, establish quality metrics, goals, objectives and accountabilities, ensuring they are in alignment with overall department and company targets, metrics and timelines. Support the company's business objectives without sacrificing product quality. Define and seek resources needed to support quality system improvements or efficiency/productivity enhancements. Execute the business plan within budget.

Job Duties:

Follow all company policies and procedures. Follow and ensure organizational compliance to quality system and cGMP programs. Provide quality and compliance oversight for multiple company locations. Review and dispose of finished product relative to customer and regulatory requirements. Inspect, utilize, deploy and/or dispose of returned goods. Responsible for the Document Control system. Responsible for the Product Standards function, development and maintenance of Master Manufacturing Records, Packaging Mater Records, Label Masters, product and material specifications, label receipt approval and disposition. Responsible for the Corrective and Preventative Action (CAPA) system. Responsible for the Quality Compliance function: review, approval and disposition of bulk and finished product inventory and associated records, maintenance of product retention system. Responsible for the Material Review Board (MRB). Designs and implements quality system process improvements through effective problem identification, root cause analysis and corrective actions. Handle and respond to any customer concerns and ensure proper audited response. Evaluate and qualify suppliers and supplier management systems, assuring optimal quality and service performances. Provide leadership, training, correction and development of staff. Perform other duties as assigned or needed.

Background Requirements:

Supervisory role of multiple direct and indirect reports. Must have a bachelor's degree or equivalent experience. Eight years of work experience. No certifications or licenses required. Must have complex math skills. Complex reading skills required. Basic computer skills needed. Must have complex language skills. Fluency in additional languages desirable. Must have complex writing skills. Must be willing to learn new tasks and procedures. Ability to efficiently and effectively perform all essential position duties and responsibilities with or without reasonable accommodation without posing a direct safety threat to self or others.

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