Director / Senior Director, Quality Assurance (GxP)

About the role

Protego Biopharma is seeking its first dedicated Quality Assurance leader to build and evolve a risk‑based, phase‑appropriate Quality Management System as the company advances its lead AL amyloidosis program into a global Phase III trial. Reporting to the SVP of Regulatory Affairs, the role will focus on GCP and GVP oversight while also providing fit‑for‑phase governance of outsourced GMP and GLP activities.

Key responsibilities

• Establish and continuously improve a right‑sized QMS covering GCP, GVP, GLP and outsourced GMP, ensuring inspection readiness and scalability.
• Oversee a contracted QA vendor to author the QMS suite (manual, policies, SOPs, work instructions) and transition authorship in‑house as the function matures.
• Implement core quality processes including document control, training management (LMS), deviation/non‑conformance handling, CAPA, change control, risk management and audit programs.
• Validate and maintain eQMS/DMS/LMS systems compliant with 21 CFR Part 11 and EU Annex 11, ensuring ALCOA+ data integrity.
• Define and deliver GxP training curricula for staff and contractors.
• Lead GCP quality strategy for proof‑of‑concept and global pivotal Phase III trials across multiple regions, interfacing with Clinical Development and Operations.
• Provide oversight of outsourced GMP activities (CDMO/CMC) and remaining GLP functions.

Required profile

• Extensive experience building and scaling QMS for biopharma programs, preferably at the sponsor level.
• Demonstrated ability to lead a first‑QA‑hire function, manage external QA resources and drive inspection readiness.
• Strong knowledge of GCP, GVP, GLP and GMP regulations (FDA, EMA, MHRA, ICH E6(R3)).
• Hands‑on, player‑coach mindset with excellent communication and cross‑functional collaboration skills.

Required skills

• 21 CFR Part 11 compliance
• EU Annex 11 compliance
• eQMS/DMS/LMS implementation and validation
• CAPA management
• Deviation and non‑conformance handling
• Change control processes
• Quality risk management
• GCP, GVP, GLP, GMP oversight