Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Director, Quality Control/ Quality Assurance - Consumer Health

Your tasks and responsibilities

YOUR TASKS AND RESPONSIBILITIES

 

The primary responsibilities of this role, Director, Quality Control Quality Assurance, are to: 

 

  • Manage the overall operation of the Quality Department, including Raw Material and Packaging Supplier Quality Assurance at the Cleveland, TN site
  • Direct, evaluate and develop staff in order to prepare them for higher-level positions.  
  • Serve  as a key member of the Cleveland, TN site management team with responsibility to assure quality and regulatory compliance of all activities including capital projects, new product introductions, and cost saving initiatives.
  • Assure the development of, and adherence to, meaningful Quality Assurance specifications for all raw materials, components, intermediates, and finished products;
  • Assure compliance to Bayer Health Care policies and directives and to FDA current Good Manufacturing Practices (cGMP's), DEA Regulations for controlled substances and agreed upon third party (customer) Quality Agreements;
  •  Provide QA approval systems for new products, trials, data reviews, and raw material changes, process changes, immediate container approvals, and other similar processes that require coordination with regulatory affairs, medical and other R&D functions at BHC Headquarters;
  • Evaluate and authorizes release for sale all Cleveland produced products for both domestic and international distribution that are judged to meet corporate, divisional, and government regulatory requirements;
  • Authorize the quarantine, rejection, or re-work of those products found not to be in compliance with all requirements;
  • Maintain QA classification and control of all materials used in production;
  • Manage the major computerized QA release systems and archival batch records systems.  These systems are indispensable for manufacturing, materials control, and distribution;

Who you are

operations;
  • Ensure adequate follow-up to all internal and external audit reports and findings to correct any deficiencies identified (e.g. FDA, TAC, third Party Customer);
  • Manage all regulatory inspectional activity at the site (related to Quality) and assures proper communication during an inspection to Global BHC QA, Regional Management and third party customers;
  • Provide support to R&D in compilations of the Chemistry and Manufacturing Controls (CMC) sections of NDA, ANDA submissions;
  • Prepare the plant for regulatory Pre-Approval Inspections necessary for new product approvals by the FDA;
  • Provide analytical lab testing support and regulatory consulting service to the Tech Ops department as they work to optimize manufacturing processes, reduce production costs, and resolve technical problems;
  • Manage the divisional stability program for long term studies;
  • Develop, evaluate, and approve chemical and microbiological methods transfers;
  • Develop; new or improved test methods to increase efficiency and/or reduce testing costs;
  • Provide technical support to Consumer Relations through investigation of consumer complaints and monitoring of complaint trends. Assists in complaint follow-up to consumers and regulatory agencies;
  • Establish and maintain a safe and healthy work environment in the quality department. Assures departmental compliance to Bayer safety standards and fully supports adherence to all OSHA and environmental regulations;
  • Support workforce diversity and company employee training and development programs;
  • Assure that the plant is registered with the appropriate authorities and obtains the applicable licenses and permits.

 

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:

 

  • Bachelors of Science Degree with at least 15 years of experience in Quality Assurance/Quality Control in the pharmaceutical, healthcare or consumer packaged goods industry;
  • Degree in Chemistry or Pharmacy preferred;
  • Total experience must include at least 10 years of supervisory experience;
  • An in-depth knowledge of chemistry, pharmaceutical analytical technologies, including microbiology and government regulations is required;
  • Familiarity with pharmaceutical manufacturing and packaging equipment is necessary;
  • A working knowledge of statistics and computerization (electronic documentation) of Quality Assurance data is required;
  • Must have a demonstrated ability to plan, organize and direct subordinates toward company and departmental goals in a rapid and effective manner;
  • Requires a demonstrated ability to support and ensure that direct reports are developed technically and prepared for higher positions of responsibility and trust;
  • A demonstrated ability to communicate effectively with people at all levels in the organization, from other departments and divisions, as well as regulatory agencies is required;
  • Must possess the ability to utilize positive human relations and negotiation skills to ensure the coordination of efforts among the management, subordinates, and peers from within and outside the Quality Assurance department required.
  • Relocation Assistance is available

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

 

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

 

Country: United States
Location: TN-Cleveland