Transversal Bio DS Operations Quality Specialist - Remote

About the Role

We are seeking a skilled Transversal Bio DS Operations Quality Specialist to join our team at UCB. This role is pivotal in overseeing quality assurance activities related to Upstream (USP), Downstream (DSP), and Media/Buffer manufacturing operations within our new commercial biologicals drug substance facility. As a Transversal Bio DS Operations Quality Specialist remote, you will ensure compliance with internal standards and drive continuous improvement in quality processes, ultimately impacting patient care positively.

What You'll Do

• Oversee quality assurance for USP, DSP, and Media/Buffer operations, ensuring compliance with UCB standards.
• Participate in Quality Operational Team meetings and share production knowledge to enhance quality practices.
• Identify production quality challenges and propose actionable improvements to processes.
• Summarize and share deviations, CAPA, and change control with the quality team.
• Train and coach GMP facilitators to elevate their process and quality knowledge.
• Review and approve GMP documentation, ensuring all production intermediates are released according to standards.
• Assist in audit readiness and participate in internal and external audits.
• Engage with regulatory authorities to maintain compliance and uphold quality standards.

Requirements

• Bachelor's or Master’s Degree in a relevant science field (Biotechnology, Chemistry, Pharmacy, etc.).
• A minimum of 5 years of experience in a GMP environment, particularly in biological drug substance operations.
• Strong communication skills to effectively engage with stakeholders.
• Fluency in both French and English is essential for collaboration across diverse teams.
• Ability to manage stress and remain composed under pressure.
• Experience in developing and implementing training programs for team members.
• Knowledge of other biomanufacturing processes (validation, maintenance, metrology) is a plus.

Nice to Have

• Experience in a hybrid work model, balancing on-site and remote responsibilities.
• Familiarity with regulatory compliance and quality management systems.

What We Offer

• Competitive salary and benefits package.
• Opportunities for professional growth and development.
• A collaborative and inclusive work environment.
• Flexibility in work arrangements, supporting a hybrid model.
• Engagement in meaningful work that impacts patient lives.