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Head of Biologics Development Quality Assurance
vor 5 Monaten
**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.**
**Head of Biologics Development Quality Assurance (M/F/d)**
**YOUR TASKS AND RESPONSIBILITIES**
- Directing and supervising the QA-group at the site Wuppertal
- Managing the functional unit in terms of resources, costs, project timelines, HR issues, and PMP and actively pursuing the improvement of processes and techniques based on broad development and QA experience
- Deciding independently on the release or rejection of biological drug substances and formulated biological bulk product as the responsible QA head, in order to ensure consistent GMP-quality and compliance
- Maintaining and improving compliant quality standards for biological development products, to assure approvability of CTAs/IMPDs/NDAs and ensuring close QA-monitoring of all manufacturing operations (internally and externally) by performing timely and professional Batch Record Reviews and the approval of Master Batch Records
- Assessing, approving or rejecting deviations, Change Requests, Out of Specification results (OOS), and Validation Plans in order to ensure GMP-compliance within production and QC functions
- Reviewing and approving SOPs, Testing Standards, and Specifications and maintains and continually improving an efficient Change Management
- System in order to assure regulatory compliance of processes and biological development products
- Supervising and finally performing the QA release of raw materials, excipients, and packaging materials used for biological development products
**WHO YOU ARE**
- Advanced degree in Biology, Biotechnology or similar field, with strong preference given to PHD, Credentialed Qualified Person (QP) strongly preferred
- Long-term experience in biological development functions, with strong knowledge of pharmaceutical production of biologics, quality control, QA, and international drug laws
- Proven track record of successful management of a biological development and/or CGT quality function
- Experience in cross-functional and multicultural teams, with proven leadership skills in managing such teams
- Very good communication skills, striving for continuous improvements and effective collaborations
- Proficient in German and English language in both verbal and written form
**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.
**Location**: Germany : North Rhine Westfalia : Wuppertal-Elberfeld
**Division**: Pharmaceuticals
**Reference Code**:789124
