Pharmaceutical Scientist - Quality Assurance Management, GMP (m/f/d)

Beschreibung

Senior Manager QA TMQ

Germany (Baden-Württemberg) Biberach

Job ID: 221870
Job Level: Experienced
Functional area: Quality
Schedule: Full-Time

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

As Senior Manager QA - Team Member Quality (TMQ) we offer you the opportunity to bring in your motivating leadership skills and broad knowledge regarding drug development and manufacturing as Team Member in R&D projects. You proactively consult international interdisciplinary R&D teams regarding GMP topics, ensure quality oversight and thereby contribute to the successful development of new drugs from a QA perspective for our rapidly developing product pipeline.

Discover our Biberach site: xplorebiberach.com

Please include a cover letter with your application.Tasks & responsibilities

• In your new role as Senior Manager QA TMQ you act as representative of Global Quality Development in international R&D project teams for GMP topics.
• You promote GMP compliance and contribute to the successful development of new NBE drugs from a QA perspective.
• As TMQ you are responsible for product quality governance in these projects from Start of Development to Launch/Transfer. This includes ensuring adequate quality oversight for multiple development projects during their development phases and the long-standing development process according to cGMP requirements.
• As Team Member you provide proactive consultancy in international R&D project teams for new drugs on GMP topics and you manage the required project related information and data exchange between Global Quality Development and the project team.
• You are the responsible function in Global Quality Development for the “QA transfer” of drug product to first manufacturer or external partner as sending unit and you support product or project specific quality topics as QA representative in the (MOCK-) PAI Preparation Team.
• In addition, you lead international and interdisciplinary quality working groups and ensure that deliverables are defined and timely achieved.

Requirements

• Master’s degree in Pharmaceutical Science, Chemistry, Biology or related field; a Doctoral degree is considered advantageous
• Proven practical experience in the area of drug manufacturing or analytics, quality assurance and/or development in the biotechnological pharmaceutical industry
• Advanced knowledge of development processes for investigational medicinal products as well as In-depth knowledge of cGMP regulations for biotechnological IMPs
• Profound cross-functional and cross-cultural leadership experience (line function, matrix, project teams) and expert knowledge of health authorities requirements (cGMP regulations e.g. EU-GMP Guide, CFR etc.)
• Conceptual thinking, high customer focus and results orientation
• Strong oral and written communication skills in English and German

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 ethnicity, color, religion, sex, sexual orientation, gender identity or national origin.