Biological Products QA Senior manager

Mision

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

Functions & Responsibilities

1. 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.
2. Oversee all key Quality Systems and deliverables associated with the drug development, playing a pivotal role in the success of our product pipeline.
3. 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.
4. Conduct comprehensive risk assessments and communicate Quality risks within the Quality organization, shaping our strategic approach to risk management.
5. 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.
6. Manage change control throughout the drug development process, ensuring smooth transitions and continuous improvement.
7. 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.
8. 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: 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 success & 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