Senior Director, Quality Assurance GCP

About Hemab

Hemab is a clinical-stage biotechnology company dedicated to developing transformative therapies for patients with rare haematological diseases. As we advance our pipeline into late-stage clinical development, we are building a fit-for-purpose Quality organization to support our growth.

Position Overview

The Senior Director, Quality Assurance GCP is a key role within Hemabs Quality function. Reporting to the Head of Quality, this individual will be responsible for creating and maintaining a robust GCP quality framework in close collaboration with Line functions. The role requires a seasoned quality professional who can operate strategically while remaining hands-on, partnering closely with line functions, internal clinical teams and external CRO and vendor partners to ensure inspection readiness throughout the clinical development lifecycle.

Key Responsibilities

Audit Planning and Execution

• Develop, own, and execute Hemabs risk-based GCP audit programme, covering CROs, investigator sites, vendors, and internal systems
• Plan and conduct audits and assessments in accordance with applicable regulations (ICH E6, EU CT Regulation, FDA regulations) and Hemabs quality standards
• Author clear, actionable audit reports and track corrective and preventive actions (CAPAs) through to effective closure
• Maintain the audit schedule and adjust plans based on emerging risks, programme milestones, and regulatory intelligence

Quality Events Management

• Oversee the management of GCP quality events, including deviations, non-conformances, and CAPAs arising from clinical operations
• Ensure quality events are investigated thoroughly, root causes are identified, and appropriate corrective actions are implemented and verified
• Analyse quality event trends to identify systemic issues and drive continuous improvement across Hemabs clinical quality systems

Support to Clinical Trial Teams

• Act as GCP quality partner to clinical operations, providing proactive quality guidance throughout the study lifecycle from protocol development through to clinical study report
• Support the review and approval of key clinical documents, including protocols, informed consent forms, monitoring plans, and data management plans
• Advise on GCP requirements in the context of Hemabs outsourced model, ensuring sponsor oversight obligations are met

Inspection Readiness

• Lead and coordinate GCP inspection readiness activities, ensuring Hemab and its CRO partners are prepared for regulatory authority inspections at all times
• Serve as a key point of contact during regulatory inspections and audits, coordinating Hemabs response and managing the inspection process

Quality Working Group Participation

• Participate actively in Hemabs Quality Working Group, contributing GCP expertise to the tactical implementation of quality initiatives and cross-functional quality topics
• Represent the GCP quality perspective in discussions on quality system improvements, metrics, and operational priorities

SOP Authorship and Approval

• Author, review, and approve GCP-related standard operating procedures, work instructions, and other quality documents to ensure they are fit-for-purpose and compliant with applicable regulations
• Drive the periodic review and continuous improvement of GCP SOPs, ensuring the document management system remains current and aligned with evolving regulatory requirements and Hemabs operating model

Building a Fit-for-Purpose Quality Organization

• Contribute to the design and development of Hemabs Quality organization as the company scales from Phase 2 into Phase 3 operations
• Help define the Quality functions strategy, operating model, and governance structures in collaboration with the Head of Quality
• Support the identification and onboarding of qualified CROs and quality vendors, and contribute to the development of quality oversight frameworks for external partners
• Serve as a role model for a quality culture grounded in patient safety, scientific integrity, and operational excellence

Qualifications and Experience

• Advanced degree in life sciences, pharmacy, or a related field
• Minimum 10 years of experience in GCP quality assurance within the pharmaceutical or biotechnology industry, with at least 3-5 years in a senior or leadership role
• Demonstrated experience planning and conducting GCP audits across a range of audit types (CRO, site, vendor, systems)
• Strong knowledge of ICH E6(R2/R3), EU Clinical Trial Regulation (536/2014), FDA GCP regulations, and related guidance documents
• Experience working in an outsourced or virtual operating model, with a solid understanding of sponsor oversight responsibilities
• Proven ability to manage regulatory inspections and lead inspection readiness programmes
• Experience authoring and approving GCP SOPs and quality documentation
• Excellent interpersonal and communication skills, with the ability to influence and partner across functions and with external stakeholders
• Self-driven, pragmatic, and comfortable operating in a lean, fast-paced environment

What We Offer

Hemab offers a dynamic, collaborative environment where you will have the opportunity to make a meaningful contribution to patients lives and to the development of a growing quality organization. You will work with talented colleagues who share a commitment to scientific excellence and operational integrity.