The Head of Quality Operations - Pine City, MN, United States - Aurora Solutions

Aurora Solutions
Aurora Solutions
Verified Company
Pine City, MN, United States

3 days ago

James Miller

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James Miller

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Freelance
Description

Head of Quality Operations / Qualified Person - Pine City, MN

230022

OUR COMPANY
At Boehringer Ingelheim, we are dedicated to developing breakthrough therapies and innovative healthcare solutions for both humans and animals.

As a family-owned company, we prioritize long-term performance and believe that with talented and ambitious individuals who are passionate about innovation, there is no limit to what we can achieve.

We started with just 28 employees and now have a global team of 50,000, fostering a diverse, collaborative, and inclusive culture.


THE POSITION
Make a difference every day


Tasks & Responsibilities:

  • As the Qualified Person, you will be responsible for approving biopharmaceutical drugs in accordance with AMG1415 and EU guidelines for Good Manufacturing Practice (GMP).
  • You will lead the "Quality Operations Drug Product Captive" team, which is responsible for the following tasks:
  • Approval of deviations, CAPAs, and change requests related to the production, storage, testing, and transport of biopharmaceutical medicinal products, following AMG, GMP Annex16, cGMP, and Boehringer Ingelheim standards.
  • Participation in new product introductions and launches.
  • Quality oversight over "fill&finish", packaging, and combination products assembled on site.
  • You will maintain excellent communication with national and international authorities, as well as internal clients, and provide necessary documents such as deviations, change requests, or quality over
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