Lead the development, implementation, and oversight of a robust Quality Management System for biopharmaceutical products.
Functions & Responsibilities
1. Lead the development and implementation of a tailored Quality Management System (QMS) for biopharmaceutical products, ensuring high standards of quality and compliance.
2. Oversee all key Quality Systems and deliverables related to drug development, contributing to the success of the product pipeline.
3. Drive cross-functional projects and Quality initiatives within CMC Teams, providing QA expertise for drug development, regulatory filings, and updates to Health Authorities.
4. Conduct risk assessments and communicate Quality risks within the organization, shaping risk management strategies.
5. Facilitate resolution of Quality issues, deviations, investigations, CAPAs, and complaints, maintaining product and process integrity and fostering a quality culture.
6. Manage change control processes during drug development to ensure smooth transitions and ongoing improvements.
7. Lead internal and supplier audits, process and product improvements, supplier evaluations, and disposition activities to uphold quality and efficiency standards.
8. Promote cross-training within the QA team to build a versatile and resilient team capable of meeting biopharmaceutical challenges.
Education
Bachelor's or Master's degree in Life Sciences or Engineering (e.g., Pharmacy, Bioengineering, Biological Sciences).
Minimum Requirements
* At least 8 years of quality-related experience in the pharmaceutical or biopharmaceutical industry of biological products.
* Strong knowledge of GMP and regulatory requirements (e.g., EU, FDA, ICH).
* Technical proficiency in quality systems.
* Knowledge of devices for biologics (e.g., combination products) is advantageous.
* Proficiency in advanced computer programs for word processing, spreadsheets, databases, statistical analysis, and flowcharts.
* Excellent organizational, analytical, and problem-solving skills with a focus on timelines and objectives.
* Ability to influence and collaborate effectively.
* Excellent written and verbal communication skills in English.
Values
* Care: Listening, empathizing, valuing diversity, and supporting each other.
* Courage: Challenging the status quo, taking ownership, and learning from experiences.
* Innovation: Focusing on patients and customers, creating solutions, and empowering entrepreneurial thinking.
* Simplicity: Acting decisively, understanding reasons before acting, and maintaining agility.
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