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Senior Global Quality Manager - OOS Process

Employer
Boehringer Ingelheim
Location
Ingelheim, Germany
Salary
Competitive
Start date
2 Oct 2022
Closing date
26 Oct 2022

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Discipline
Quality, Regulatory Affairs, Compliance
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

OUR COMPANY

At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.


THE POSITION


In your new role you will give active support to operative units for quality and compliance related topics and projects.


Tasks & responsibilities


  • As Senior Quality Manager, you’ll act as owner of the Quality Systems Out of Specification (OOS) at a corporate/global level (GMSO).
  • You’ll ensure adherence of BI sites and contract partners worldwide to current and emerging legal quality / GMP authority requirements and norms.
  • Moreover, you’ll ensure GoTrack IT Tool processes support investigation as well as CAPA handling of Out of Specification (OOS), Out of Trend (OOT) and Out of Expectation (OOE) for all relevant divisions and organizations.
  • One of your key tasks will be to define and implement a “fit for purpose and fit for future” strategy for relevant quality systems.
  • You’ll drive the data analytics program for relevant systems with the aim of developing risk prediction tools for BI’s products and site performance.
  • Driving the change management (mindset, quality culture, tools) in parallel to strategy definition and implementation will also be part of your profile.



Requirements


  • Academic degree (e.g., B.Sc., M.Sc., Ph.D. preferred) in life science, chemistry, engineering or comparable with a major focus on (bio-)pharmaceuticals
  • Long-term professional experience in a GxP regulated environment
  • Several years of experience in a managerial or influencing position being accountable for QC operations, OOS/OOT/OOE processes and investigations, and/or deviation management
  • Few years of experience in leading international and intercultural teams
  • Expert knowledge of quality / GxP regulations and regulatory processes; experience with regulatory processes within industry preferred
  • Excellent knowledge and practical experience with Trackwise (GoTrack)
  • Ability to work strategically and conceptually (concept definition and communication) with a focus on cross-functional and cross-cultural alignment
  • Fluency in the English language, both verbal and written



WHY BOEHRINGER INGELHEIM?


This is where you can grow, collaborate, innovate and improve lives.

We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth. We also offer a competitive salary, generous amount of vacation time, and numerous benefits towards your wellness & financial health and work-life balance. Plus, an onsite gym (Ingelheim), in-house doctor and best-in-class cafeterias and coffee bars to keep you energized and healthy. To learn more about what benefits could be waiting for you, please visit our Career area .

Want to learn more about us? Visit https://www.boehringer-ingelheim.com/

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin.


READY TO CONTACT US?


Please contact our Recruiting EMEA Team, Tel: +49 (0) 6132 77-173173

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Company

With 47,700 employees in 103 countries, Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies. Since its foundation in 1885, the family-owned company has been pursuing an ambitious goal: to research and develop innovative pharmaceuticals that improve the health and quality of life of humans and animals alike

Find Us
Website
Location
Binger Straße 173
Ingelheim am Rhein
55216
Germany
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