Director of Quality Assurance

Kelly Science & Clinical is seeking a Director - Quality Assurance southeast of Cleveland, OH.

Direct Hire

Relocation assistance provided

We are seeking a Quality Assurance professional with experience and responsible for establishing and maintaining cGMP procedures and Quality Management Systems. The individual will lead the effort in providing oversight of all Quality Assurance activities. The position will also have technical and support responsibilities to win and manage commercial customers.

Duties include:

• All day to day Quality Assurance responsibilities.
• Providing Quality oversight and approval for a wide variety of internal laboratory activities that include stability studies, formulation development and characterization, process development, manufacturing of prototype formulations, and developing and executing analytical chemistry test methods.
• Responsible for the Quality Management System; including drafting, routing for approvals, distributing current revisions of Quality documents, initiating and documenting training, providing strategic direction to the company to continuously improve Quality.
• Manufacturing site identification, inspection, and qualification of CDMOs for company’s programs that require contract development and manufacturing and providing Quality oversight during production through release of company’s pharmaceutical products.
• In partnership with QC Operations, lead the identification and implementation of strategic facility and equipment initiatives, QMS continuous improvements, and oversight of third-party standards (FDA, GMP, ICH, ISO, etc.) to ensure continuous improvement and that customer needs are met.
• Lead efforts to identify, inspect, and qualify all appropriate cGMP vendors on an ongoing basis that includes CMOs, excipient and chemical suppliers, contract labs, and other organizations, as required.
• Manage storage of quality system records (paper and electronic) including SOPs, technical reports, training records, log books, and others as necessary.
• Provide Quality Assurance and program updates for customers, project teams, and other groups as needed.
• Provide technical input to Business Development for proposal preparation and Lead management
• Other duties as assigned

Requirements:

• A BS or MS in chemistry, pharmaceutics, chemical engineering, or other closely related fields.
• 15 years or more of pharmaceutical industry experience with an emphasis on Quality Assurance.
• A thorough understanding of the Quality Assurance function in the pharmaceutical and biotech industries.
• A thorough understanding of FDA, ICH and cGMPs requirements for pharmaceutical formulation, analysis, stability and manufacturing of drug products.
• Excellent verbal and written communication skills
• Self-motivated individual with self-starting capabilities
• Motivated to learn new skills and applying them to success and growth of company
• Must be a US citizen