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.
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