Senior Director, Quality Assurance GCP
Hemab Therapeutics, Boston, MA, United States
Position Overview
The Senior Director, Quality Assurance GCP is a key role within Hemab's 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 Hemab's 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 Hemab's 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 Hemab's 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 Hemab's 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 Hemab's response and managing the inspection process Quality Working Group Participation
Participate actively in Hemab's 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 Hemab's operating model Building a Fit-for-Purpose Quality Organization
Contribute to the design and development of Hemab's Quality organization as the company scales from Phase 2 into Phase 3 operations Help define the Quality function's 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.
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The Senior Director, Quality Assurance GCP is a key role within Hemab's 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 Hemab's 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 Hemab's 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 Hemab's 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 Hemab's 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 Hemab's response and managing the inspection process Quality Working Group Participation
Participate actively in Hemab's 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 Hemab's operating model Building a Fit-for-Purpose Quality Organization
Contribute to the design and development of Hemab's Quality organization as the company scales from Phase 2 into Phase 3 operations Help define the Quality function's 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.
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