Director of Quality

Bayer   •  

Shawnee, KS

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 51 days ago

The primary responsibilities of this role, Bayer Animal Health Director of Quality are to:

  • Direct the activities of the Manufacturing QA, Pharm QC, Environmental Control, sterility testing, endotoxin testing, Compliance and Validation areas to provide oversight and support to the Manufacturing, QA/QC Departments to assure that quality systems are in place and all appropriate requirements are being met. Activities include, but are not limited to, establishing quality systems, procedures and practices, audit of technical operations activities, review of all batch records for release for sale, administration of specifications and standards, label coordination, implementation of Good Manufacturing Practice (GMP) regulations, training, quality standards, and primary contact for regulatory inspections including FDA, EPA, OSHA, USDA, UK and EU;
  • Administrate the Document Control group that provides a document system to control, approve and administer master documentation as it relates to Bayer Animal Health, North America, and production. For the review and approval of all specifications, test methods, SOP’s and batch records impacting on the quality of products manufactured at Bayer Animal Health, North America, as well as for contract manufacturers;
  • Provide leadership to the Bayer Animal Health North America Business Group to create a coordinated team effort including QA, QC, Production, Engineering, R&D, Human Resources, Supply Chain, Regulatory, and Validation groups;
  • Be responsible for timely delivery of quality product and accurate and effective support to the Production Department and other departments for Bayer Animal Health, North America;
  • Be responsible for the establishment of a Quality Policy and Quality Systems including GMP/GLP procedures to meet worldwide regulatory requirements which provide controls for effective and reproducible operations in the entire Bayer Animal Health organization from research and development, through production, testing and distribution, to include field complaint follow-up in order to accomplish continuous improvement. Responsible for providing expertise to the emerging global Animal Health QA function in Monheim, to assure a timely and complete Quality Program for a global quality function to meet all regulatory requirements worldwide;
  • Be responsible for the change control process which assures that as changes to our procedures or processes (bulk, in process or finished product) occur, that we have adequate data to support the change for preparation and submission of federal and state applications;
  • Be responsible to establish/maintain discipline and adherence to procedures. Assure assigned operations are conducted in conformance with applicable government regulations and in-house specifications, including health, safety and environment. This includes the development of appropriate compliance audit programs, follow-ups and improvement procedures;
  • Be responsible for hiring, developing and training employees in the field of quality, laboratory testing, validation who can perform these duties at Bayer Animal Health, North America and be prepared to be utilized/transferred elsewhere in the company. Administers and develops systems for effective performance evaluation;
  • Be responsible for budgeting, cost monitoring and control for the QA/QC Departments;
  • Participate in FDA, OSHA, EPA, USDA/APHIS, UK, and EU activities related to attaining and maintaining North American and European licenses;
  • Develop standards for major operational issues such as validation standards, quality standards, change control training, facility, utility, equipment standards;
  • Represent Bayer Animal Health, North America, in the worldwide organization as it relates to quality issues and standards. An active participant in the global Pharma / Animal Health CCQA groups that provide scope, policy and direction to company Q.A. philosophy on key issues. This includes policy writing and review, problem solving, quality data review and quality goal setting;
  • Be part of the worldwide Bayer Animal Health Quality Team, this position is responsible for the European active ingredient supply and NAFTA supplies of components and products as they relate to quality certification and quality audits (GMP, etc.) for the worldwide Bayer Animal Health organization.

Who you are

Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

  • Requires a Bachler of Science or Bachler of Business Administration and a minimum of ten to fifteen years’ experience with emphasis related to both veterinary biological and pharmaceutical products. Requires professional scientific education with emphasis on microbiology, biology, chemistry, virology or related fields. Further education in Business Administration is also desirable;
  • Profound expertise in QA, Pharm QC, Bio QC, Validation, Environmental Control and GMPs;
  • Experience in production, regulatory and administrative areas, including engineering, cost planning, inventory control, and human resources is a plus;
  • Experience in dealing directly with regulatory agencies with particular emphasis on FDA;
  • Proven experience in dealing with outside contacts for contract manufacturing regarding QA/QC, production and validation concerns when initiating new production in the facility. Experience in decision making and dealing with the risks involved with contract work;
  • The incumbent must be able to assess trends in the regulatory area and be pro-active in defining regulatory deficiencies and solving them prior to inspections by the regulatory agencies;
  • Requires experience in dealing with multiple site issues, renovation and new construction experience from compliance as well as an economic perspective.