Quality Officer - Bio DS Operations

About the role

Our client, a leading pharmaceutical company, is looking for a Quality Officer to lead quality assurance activities in a new biological drug substance facility. The role ensures compliance across upstream, downstream and media/buffer operations while supporting continuous improvement in a dynamic manufacturing environment.

Key responsibilities

• Oversee quality assurance for upstream, downstream, and media/buffer production processes.
• Review and approve deviations, corrective and preventive actions (CAPA), and change controls to maintain regulatory compliance.
• Execute review and approval of batch records for all production batches.
• Escalate quality issues to management in line with the Quality Management System (QMS) procedures.
• Participate in Annual Product Reviews and collaborate with cross‑functional stakeholders to align quality objectives with production goals.

Required profile

• Bachelor’s or Master’s degree in Biotechnology, Chemistry, Pharmacy or a related scientific discipline.
• Approximately 8 years of experience working in a GMP‑regulated environment.
• Demonstrated experience in biological drug substance operations from a quality or business perspective.
• Fluent in both French and English.

Required skills

• Proficiency in CAPA, deviation management and change control processes.
• Strong knowledge of GMP compliance and quality assurance methodologies.