Lead the development, implementation, and oversight of a robust Quality Management System for biopharmaceutical products.
Functions & Responsibilities
* Lead the development and implementation of a tailored Quality Management System (QMS) for biopharmaceutical products, ensuring high standards of quality and compliance.
* Oversee all key Quality Systems and deliverables related to drug development, contributing to the success of the product pipeline.
* Drive cross-functional projects and Quality initiatives within CMC Teams, providing QA expertise for drug development, regulatory filings, and updates to Health Authorities.
* Conduct risk assessments and communicate Quality risks within the organization, shaping risk management strategies.
* Facilitate resolution of Quality issues, deviations, investigations, CAPAs, and complaints, maintaining product and process integrity and fostering a quality culture.
* Manage change control processes during drug development to ensure smooth transitions and ongoing improvements.
* Lead internal and supplier audits, process and product improvements, supplier evaluations, and disposition activities to uphold quality and efficiency standards.
* 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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