Head of Quality Not right for you? We've got others

$180,000 - $220,000
Saint Louis, Missouri
September 13th 2021
Minimum Degree:
Relocation Assistance:
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Primary Responsibilities and Essential Functions of the Position:

 • Direct the development of short-term and long-term goals and objectives and assure that year-end goals are attained.

• Ensure that departmental performance meets the expectations of customers (internal and external) and support the achievement of broader business goals.

 • Direct and review quality compliance audits and document control.

• Organize, approve, and direct training sessions and programs.

• Guide, instruct, and coach members of management in compliance issues.

• Oversee the label control program, including inventory, accountability, and reconciliation of labels and labeling inventories.

• Oversee all in-process QC inspection and testing activities including Microbiology.

• Assist the QC head and QC lab in planning to ensure on-time release of commercial product batches as well as exhibit batches

 • Oversee

• Review and approve master batch records, analytical methods, validation and cleaning protocols and reports, annual product review reports, standard operating procedures (SOPs), change control documents, etc.

• Development and oversight of Supplier Qualification Program..

• Host FDA inspections, Corporate Quality inspections, and inspections by any consultants / customers • Work closely with Regulatory Affairs to coordinate responses to regulatory authorities (e.g., the FDA), FDA Form 483 responses, client responses, etc.

• Serve as primary contact for site-specific customer and regulatory audits.

• Perform root cause analysis with appropriate site personnel and ensure that necessary corrective actions are implemented. Track and measure effectiveness of corrective actions.

• Develop, implement, and maintain internal auditing program.

• Work with Corporate QA to ensure site compliance with the company's corporate Quality Management System (QMS).

 • Ensure that controlled documentation is generated, revised, approved, and maintained per company Standard Operating Procedures (SOPs) and regulatory agency procedures.

• Ensure potential or existing quality issues that may jeopardize cGMP compliance or regulatory position are addressed to an appropriate end.

 • Ensure that department activity is coordinated with departments within and outside of Quality operations.

• Annual budgeting and budgetary control for Quality department

• Recommend / suggest upgrading QC lab and QA with respect to new instruments, techniques, controls and compliance software

Growing Company 

Great Benefits & Cluture

WorldWide Presence. 



Skills and Abilities Required:


Minimum Education and Experience Required:


Physical Requirements:


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