Director of Quality
The Director of Quality is responsible for all quality related decisions at the Evonik Lafayette plant site. This role will establish and maintain an independent quality organization, ensuring compliance to pharmaceutical Good Manufacturing Practices (cGMPs), customer, external, governmental, and requirements. In addition, this function is responsible for the Quality Control Laboratories, which develops, implements, and executes all analytical test methods for raw materials, in-process controls of intermediates, and release testing for final products at the site. This function approves all site standards, policies, and procedures related to maintaining cGMP and ISO standards and has cGMP oversight for all affected site functions. RESPONSIBILITIES Develop, implement and continuously improve the quality system procedures that are effective and compliant to applicable standards, as outlined in ISO 9001, RC 14001 and applicable cGMP regulations for Active Pharmaceutical Ingredients (e.g. 21 CFR 211, EU GMP Guide Part I, ICH guidelines). Provide leadership to a team of Quality Assurance (QA), Quality Control (QC) and RA personnel Establish cGMP training systems and perform on-site staff training in quality-related matters. Operate as an independent subject matter expert for the Quality function to ensure delivery of product that meets regulatory and customer requirements. Ensure the Quality Control Laboratories meet business and customer requirements with respect to the development and transfer of testing methods for raw materials, in-process controls, and intermediate and final products. Author Quality Agreements between Evonik and clients Coordinate and host customer audits and develop audit responses as required by the respective auditing customer. Coordinate and host regulatory agency audits, coordinate follow-up communication and supervise necessary corrective actions on site. Coordinate and host ISO 9001 / RC 14001 audits. Ensure compliance with all commitments (to customers or authorities) in conjunction with regulatory approvals of products and processes Establish and manage QA tracking and trending of essential performance measures and the preparation of periodic reports for management review. Propose and develop continuous quality initiatives to improve efficiency, reduce or contain costs, or improve the level of control and compliance. Set up and maintain appropriate KPI s to monitor performance and improvement. Promote a Quality culture at Evonik with appropriate responsibility and accountability at all levels and functions of the site. REQUIREMENTS Bachelor's degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or related is required. 10
years of experience in a regulated industry such as pharmaceutical or food Past experience within a Quality department is preferred Leadership experience Ability to effectively plan and manage multiple tasks and/or initiatives simultaneously Strong work ethic and high level of integrity Strong negotiating and decision making skills Proficient at building and maintaining business relationships Strong communication skills (verbal and written), including the ability to interact with suppliers and customers
Salary Range:
$200K -- $250K
Minimum Qualification
Quality Management, Operations ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
years of experience in a regulated industry such as pharmaceutical or food Past experience within a Quality department is preferred Leadership experience Ability to effectively plan and manage multiple tasks and/or initiatives simultaneously Strong work ethic and high level of integrity Strong negotiating and decision making skills Proficient at building and maintaining business relationships Strong communication skills (verbal and written), including the ability to interact with suppliers and customers
Salary Range:
$200K -- $250K
Minimum Qualification
Quality Management, Operations ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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