Career Story: Global Quality Manager For A Drug Company

Global Quality Manager For A Drug Company

Job Title: Pharmaceuticals Global Quality Manager

Type of Company: A pharmaceutical company specializing in cancer drugs.

Education: BS, Biology, UMass-Dartmouth

Previous Experience: I started as a quality assurance inspector out of college and then found another job as a quality assurance specialist. After leaving that company, I moved into quality management. It is my 10th year in the industry and I am now at my fifth company.

Job Tasks: My primary responsibility is to ensure that the drugs produced by my company are safe for general use. I do this by performing quality system audits of companies and manufacturing sites which provide us with services or materials that are used in the manufacture of our drugs. After an audit is complete, I will send the site an observation letter to inform them of areas that we think need improvement. The observations are classified as "critical," "major," or "minor." Critical observations could potentially affect the drug quality and that could have an adverse effect on a patient's health, and the vendor is responsible, as a consequence, for providing a prompt response. To continue doing business with us, they have to provide the dates of completion of the steps they've taken to address our observations.

The US government's FDA agency also audits my company to make sure that our drugs are safe for human use. Additional responsibilities of my department include training other personnel to make sure they are familiar with all of the government's regulations.

Best and Worst Parts of the Job: The best part of my job would be that it is rewarding. My company provides drug therapy to people who are very sick with cancer and many times the therapy improves the patient's condition.

the worst part would be all of the travel. It's about 50% of the time and it often runs over into weekends.

Job Tips: To do this job, you need to be organized, efficient with your time, and dedicated. The job also requires someone to be able to multi-task and shift focus quickly. Being efficient with your time is critical as there are many deadlines set with each project or audit to ensure the drugs produced are safe for release to the public.

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