BAYER

Director Inspection Preparedness

Posted on: 26 Mar 2020

Houston, TX

Job Description

The primary responsibilities of this role, Director Inspection Preparedness, are to: 

Review the sites’ current processes to prepare for HA inspections and run inspections;
Challenge current processes per the FDA requirements and guidelines;
Drive improvement of the sites’ inspection preparedness plans;
Complete SWOT analysis and Map and create an action plan of strengths and weaknesses of current processes;
Propose improvement strategies and prepare implementation plans in close cooperation with Divisional Q;
Enhance the overall compliance profile of the company to ensure patient safety and safeguarding the Bayer brand;
Ensure Quality compliance and inspection readiness of the sites;
Challenge current process by providing insights per the FDA perspective with the objective to increase robustness of inspection preparation and execution;
Improve HA inspection results and thus guarantees the sites’;
Be able to always ensure the company’s license to operate.
 

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:

Bachelor’s degree;

At least 5 years of experience as US FDA field investigator;

At least 15 years of experience as GMP auditor or Quality Manager;
Broad background and overview across the industry to assess current; industry practice and standards;
Strong audit background, good network within industry and FDA mandatory.

Preferred Qualifications:

Master’s degree.

Visa Sponsorship Available

BAYER

Albany, NY

For over 150 years, Bayer has been an innovation company rooted in science. Our presence in the U.S. harkens back to the mid-19th century as a chemical company making dyes in Albany, NY. By the late 19th century, we moved into the healthcare field with the introduction of one of our flagship products, Aspirin. Throughout the next two centuries, we have developed scientific and medical breakthroughs and continued creating some of America’s most loved brands.

In line with our mission “Bayer: Science for A Better Life,” we aim to improve people’s quality of life. For this endeavor, we focus on our core competency of developing and successfully commercializing innovative products and solutions based on scientific knowledge.

Our solutions help farmers in America provide adequate nutrition to our growing population while maintaining the health and sustainability of our environment.
We are improving people’s quality of life by preventing, alleviating or curing diseases.
We are developing innovative care for animals—providing family pets with a longer, better quality of life and ensuring the health and safety of livestock.
Our high-tech polymer materials are making significant contributions in areas such as energy and resource efficiency for mobility, construction and home living.

 

  • Industry
    Biopharmaceuticals
  • No. of Employees
    110,838
  • Jobs Posted
    44

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