Biological Products QA Senior manager

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, database 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 essential.

Values

• Care: we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.

• Courage: we challenge the status quo, we take full ownership and we learn from our successes & failures.

• Innovation: we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets.

• Simplicity: we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.