Biological Products QA Senior manager (m/f/d)

Your Profile:

• Bachelors/Masters Life Science/Engineering (Pharmacy, Bioengineering, Biological Sciences or similar subject).
  
• +8 years quality related experience in pharmaceutical or biopharmaceutical industry of biological products.
  
• Strong knowledge of GMP and regulatory requirements (e.g., EU, FDA, ICH).
  
• Technical working proficiency in quality systems.
  
• Knowledge of devices for biologics (e.g., combination product) would be considered an advantage.
  
• Good knowledge and skills in the use of advanced personal computer productivity programs for word processing, spreadsheets, data base manipulations, statistical analytical and flow charts.
  
• Strong organizational, analytical mindset, and problem-solving skills to perform varied tasks in a functionally independent and consistent manner with a clear focus on timelines and objectives.
  
• Ability to influence and collaborate with others.
  
• Good written and verbal communication skills in English are essentials.

Your Tasks:

• Lead the development and implementation of a robust Quality Management System (QMS) specifically tailored for our biopharmaceutical products, ensuring the highest standards of quality and compliance.
  
• Oversee all key Quality Systems and deliverables associated with the drug development, playing a pivotal role in the success of our product pipeline.
  
• Drive cross-functional projects and Quality initiatives within CMC Teams, providing expert Quality Assurance input for all aspects of the drug development process, ongoing regulatory filings and updates to Health Authorities.
  
• Conduct comprehensive risk assessments and communicate Quality risks within the Quality organization, shaping our strategic approach to risk management.
  
• Facilitate the resolution of Quality issues on deviations, Investigations, CAPAs, and Complaints in a timely manner, maintaining the integrity of our products and processes by fostering effective interdepartmental and cross-functional relations, promoting a culture of quality across the organization.
  
• Manage change control throughout the drug development process, ensuring smooth transitions and continuous improvement.
  
• Lead internal quality audits, supplier audits, process/product improvement projects, supplier evaluation surveys, and disposition activities, ensuring our operations meet the highest standards of quality and efficiency.
  
• Promote cross-training within the QA team, fostering a versatile and resilient team ready to meet the challenges of a dynamic biopharmaceutical environment.

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