Senior Manager QA CRO - 200056

Boehringer Ingelheim

Senior Manager QA CRO - 200056

Boehringer Ingelheim

Biberach, Germany

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

Working as Senior Manager QA means collaborating with highly motivated, cross-functional teams within Boehringer Ingelheim as well as joining forces with external partners.

You are involved in the projects where biological Investigational Medicinal Products for use in our clinical trial programs are developed, manufactured and/or tested externally. Your focus will be on assuring the highest standards concerning product quality and patient safety always ensuring compliance with GMP requirements as well as with regulatory and internal requirements.

Join our multinational team and start your next chapter towards success.

Tasks and responsibilities

  • In your new role, you are the primary Quality Assurance contact for our contract manufacturers, contract laboratories or service providers in their day-to-day business to ensure quality oversight as well as compliance to GMP and regulatory requirements;
  • You execute supplier qualifications and ensure implementation of life-cycle-management according to internal procedures. This includes negotiation and update of Quality Assurance Agreements;
  • In addition, you will conduct GMP audits at external companies and follow-up on the agreed upon corrective and preventive actions. You also evaluate external quality incidents and review associated investigation reports including CAPA;
  • You act as a quality expert for (bio) pharmaceutical and/or ATMP manufacturing processes and you will become key contact partner for Development Project Teams to represent quality aspects;
  • You will lead (or participate in) global initiatives and quality projects to ensure GxP compliance within Corporate Development and you will represent our department in external, global and intercompany committees.

Requirements

  • Master degree in pharmaceutical sciences, Chemistry, Biotechnology or a related field with deep professional experience in an international environment or a comparable vocational training with long-term professional experience in an international environment;
  • Expert knowledge of international regulatory guidelines (EU, US, ICH) and quality/GMP standards and the derived quality management systems;
  • Experience in Quality Management and/or qualification as a GMP/Quality Auditor;
  • Fluent oral and written communication skills in English and German;
  • Profound experience in leading projects (e.g. process improvements, development project related activities);
  • Willingness and ability to travel locally and internationally.

EFFECTS OF COVID-19

We will continue to hire talented people and we look forward to receiving your applications. As a result of COVID-19, we have introduced alternative working arrangements to ensure that our employees can stay safe and healthy, because the health of our employees is among our top priorities. At all company locations, we work remotely whenever possible. Additionally, we are now hosting virtual video interviews for applicants. During the limited in-person interviews we still have during this time, we pay special attention to distance and the hygiene rules recommended by the Robert Koch Institute. New employees who do not start on site in production or the laboratories are sent the necessary IT equipment, our Welcome Days take place online, and we plan to conduct their onboarding training virtually whenever possible.

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: Artur Reich, Tel: +49 (7351) 54-175904.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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