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Director of Quality

Date: Sep 15, 2021

Location: Lafayette, IN, US

Company: Evonik Industries AG

Discover a world of opportunities. #HumanChemistry

See what chemistry can do for your career: careers.evonik.com


Exploring opportunities. Growing together.

 

VACANCY REFERENCE NUMBER 144059
 

Director Quality (Tippecanoe)

 

Location: United States : Lafayette, IN

Function: Innovation Management (R&D)

Career Level: Senior professionals (> 5 years)

Legal Entity: Evonik Corporation

Business Line: Health Care

 

What we offer

You will work on exciting and challenging topics together with a team in an ultra-modern, innovative and creative environment. Intensive on-the-job training with expert colleagues guarantees you will quickly become familiar with your duties and perform them independently. Performance related pay and the opportunity for personal and professional development are of course part of the package. Since 2009 Evonik Industries AG has been certified as a family-friendly company by the German Hertie Foundation.

Click here to learn more about Evonik from our employees

 

 

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 internal 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
 

Your Application

To ensure the fastest process of your application and to protect the environment, please apply online via our careers portal at https://careers.evonik.com.

VACANCY REFERENCE NUMBER 144059

Evonik Corporation is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, gender, sexual orientation, national origin, disability status, protected veteran status or any other legally protected status.

Please note that Evonik will not accept any unsolicited application documents sent by staffing firms. Evonik works in conjunction with preferred service providers and will not pay any fee to staffing firms in the absence of an appropriate framework agreement. Should Evonik receive a candidate profile from a staffing firm with which it has no framework agreement, and should this candidate subsequently be considered in the recruitment process or offered employment, no claims from the staffing firm will be entertained in this regard.
 


Nearest Major Market: Lafayette