Biological Products QA Senior manager

hace 1 semana

Lleida, España Almirall A tiempo completo
Fecha: 6 nov. 2024 Ubicación: SAB0 - PHARMA SANT ANDREU DE L Mision

Lead the development, implementation and oversee of the robust Quality Management System for biopharmaceutical products.

Functions & Responsibilities
  • 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.
Education

Bachelors/Masters Life Science/Engineering (Pharmacy, Bioengineering, Biological Sciences or similar subject).

Requirements
  • +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.
Values
  • Care
  • Courage
  • Innovation
  • Simplicity
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