Head of Biologics Development Quality Assurance in Wuppertal bei Bayer AG

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 (f/m/d)

The QA Biological Development is a central function at Bayer Pharma that involves developing, implementing, and applying GMP-relevant
quality assurance processes for the development of Biologics, with special focus on the Antibody, Antibody-Drug-Conjugate (ADC), and
Cell and Gene therapy pipelines. The development of new biological products is of strategic importance to Bayer. By providing state-of-the-art
QA processes at Biological Development Wuppertal, this function ensures timely clinical trial supply, guarantees patient safety, and ensures
regulatory and GMP compliance for the Wuppertal development portfolio. This is a major prerequisite for a successful product registration and
is essential for Bayer to maintain a strong position in product liability. The Head of Biologics Development Quality Assurance (m/f/d) at the site
Wuppertal is responsible for fulfilling legal requirements and is personally liable for all release decisions as Head of QA and as Qualified Person.
Essentially, this role includes:

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
• Developing and implementing harmonized efficient processes by applying state-of-the-art QA-principles and cooperating closely with the QA
  Head BD at the site Berkeley to assure harmonized and consistent standards at the different BD sites
• 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

Applications from employees in Germany who may be affected by personnel reduction will be treated favourably.

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 membershi