Senior QA Manager Data Integrity (m/f/d)

Key Skills

Java Programming, Python Programming, SQL, German Language

Job Description

• As part of this role, you are in charge of the data integrity program 1.0/2.0 for the manufacturing site in Bitterfeld-Wolfen
• You will provide quality oversight for all data integrity (DI) related matters
• You take on all data integrity related strategies at the site 
• Responsibility for DI related activities of the annual quality plan (according to FDA guidance for industries), strategic compliance programs and other strategic initiatives as per site business strategy
• Furthermore, the implementation of global standards into local quality systems will be part of your work
• Support in providing state-of-the-art quality management systems, developing a quality-business strategy for quality systems and metrics 4.0 for DI related matters
• You are in charge of training all pharmaceutical functions in Data Integrity, while providing legal context and regulatory strategies

WHO YOU ARE

• You have a bachelor’s or master’s degree in science (chemistry, biology, pharmacy) or economy and equivalent experience in QA and manufacturing of pharmaceuticals
• Several years of experience in the field of data integrity, quality assurance and project management
• Strong background in manufacturing of pharmaceuticals
• Full knowledge of cGMP-legislation for EMEA-region, US and ROW countries.
• Full knowledge of regulatory guidelines of chemistry, manufacturing and control (CMC)
• As change leader (m/f/d) you have a strong affinity for digital ways of working
• Excellent communication skills in English and German are required

YOUR APPLICATION

This is your opportunity to tackle the world’s biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change. You have a voice, ideas and perspectives and we want to hear them. Because our success begins with you. Be part of something big. Be Bayer.

Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.