Senior Quality Specialist, Technical

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Quality Specialist, Technical based in United States.

This role supports quality assurance activities across solid oral dose and biologic product programs, helping ensure products meet regulatory and quality requirements.
You will contribute to qualification and validation activities spanning manufacturing processes, analytical test methods, and product transfer initiatives.
The position works closely with cross-functional teams and external manufacturing partners to support safe, effective products for clinical and commercial use.
You will review technical documentation, manage quality workflows, assess data, and help maintain strong compliance across the product lifecycle.
The role offers exposure to GMP Quality Systems, electronic QMS platforms, regulatory requirements, investigations, CAPAs, and validation activities.
You will also build technical expertise through collaboration, knowledge sharing, coaching, and mentoring in a fast-paced environment.
This is an opportunity to make a direct contribution to quality and compliance within a science-driven organization focused on rare disease therapies.