Senior / Executive Director, Clinical Quality Assurance

Position Overview 

Immunome is seeking a highly experienced and strategic Senior / Executive Director, Clinical Quality Assurance to lead and implement global clinical quality strategies supporting Immunome’s oncology portfolio. This role will provide quality leadership across clinical development, clinical operations, pharmacovigilance/drug safety, nonclinical and translational partners, data management, regulatory affairs, and external vendors. 

The successful candidate will bring deep expertise in GCP, GLP/GCLP, and GVP/GPV expectations, global inspection readiness, outsourced development oversight, and fit-for-purpose quality systems. This position offers a highly visible leadership opportunity to scale Immunome’s clinical quality capabilities, ensure patient safety and data integrity, and support high-quality execution from clinical development through regulatory submission, launch readiness, and post-marketing commitments. 

Responsibilities 

Clinical Quality Strategy and Governance 

• Develop and implement a risk-based Clinical QA strategy across GCP, GLP/GCLP, and GVP/GPV activities aligned with Immunome’s pipeline, corporate objectives, and global development plans. 

• Serve as a senior quality leader and subject matter expert for clinical quality matters, including quality risk management, inspection readiness, regulatory intelligence, issue escalation, and quality governance. 

• Establish clear roles, responsibilities, escalation pathways, quality metrics, and decision-making forums across internal teams, vendors, partners, affiliates, and consultants. 

• Represent Clinical QA on R&D governance forums, program teams, safety governance forums, quality councils, launch readiness teams, and regulatory inspection teams. 

Clinical Trial and Development Oversight 

• Provide strategic and hands-on QA oversight for global clinical trials from protocol development and study start-up through conduct, closeout, clinical study reports, regulatory submissions, and inspections. 

• Partner with Clinical Operations, Clinical Development, Medical Affairs, Biostatistics, Data Management, Regulatory Affairs, and CROs to embed quality into study design, monitoring strategy, data flow, protocol deviation management, and trial documentation. 

• Ensure clinical trials are conducted, documented, and reported in compliance with applicable regulations, ICH GCP, study protocols, informed consent requirements, Immunome SOPs, and quality agreements. 

• Oversee clinical quality activities, including site audits, CRO oversight, eTMF quality, protocol deviations, serious breach assessments, nonconformances, root cause analysis, CAPA development, and CAPA effectiveness. 

PV/GVP and Launch Readiness 

• Provide QA oversight of pharmacovigilance and drug safety systems across clinical development and post-marketing activities, including safety case intake, processing, medical review, expedited reporting, aggregate reporting, signal management, safety database governance, and vendor oversight. 

• Lead or support European and global launch readiness activities for PV/GVP, including PSMF and QPPV interface, local safety contact readiness, safety data exchange agreements, literature monitoring, medical information/product complaint reconciliation, and regulatory inspection preparedness. 

• Partner with Drug Safety, Regulatory Affairs, Medical Affairs, Commercial, Legal/Privacy, Technical Operations, Supply Chain, and external partners to ensure launch-related quality activities are appropriately documented, trained, governed, and inspection-ready. 

Audit, Inspection, and Vendor Quality Management 

• Design and execute a risk-based audit strategy for clinical sites, CROs, central and specialty laboratories, PV vendors, computerized systems, internal processes, affiliates, and partner organizations. 

• Identify, qualify, and oversee external vendors and partners to ensure high-quality, timely, compliant execution and clear sponsor oversight across highly outsourced development activities. 

• Lead periodic quality reviews with critical vendors to evaluate metrics, audit findings, inspection history, deviations, CAPAs, service issues, data integrity risks, and continuous improvement opportunities. 

• Prepare Immunome and external partners for global health authority inspections, including FDA, EMA, EU Member State, MHRA, PMDA, Health Canada, and other applicable regulatory authorities. 

Quality Systems, CAPA, and Continuous Improvement 

• Own or co-own Clinical QA processes within the QMS, including SOPs, audit management, deviations/nonconformances, CAPAs, change control, training, document management, vendor qualification, quality agreements, and management review. 

• Define and monitor quality metrics, dashboards, risk logs, quality signals, issue trends, audit trends, inspection trends, CAPA effectiveness, vendor quality performance, and inspection readiness status. 

• Provide QA oversight of regulated computerized systems and records used in clinical development and PV, including eQMS, LMS, DMS, eTMF, EDC, CTMS, RTSM/IWRS, statistical programming tools, data warehouses, and safety databases. 

• Drive continuous improvement by using audit outcomes, inspection intelligence, regulatory intelligence, metrics, and benchmarking to strengthen policies, systems, training, and operational execution. 

Leadership and Collaboration 

• Build, lead, coach, and develop a high-performing Clinical QA team and/or network of consultants and outsourced auditors, establishing clear objectives, priorities, accountability, and development plans. 

• Set expectations for pragmatic, risk-based, business-facing QA support that enables speed, quality, patient safety, data integrity, and regulatory trust. 

• Manage department budgets, audit/vendor resources, consultant engagements, and capacity planning in alignment with pipeline, launch, and inspection priorities. 

• Promote a culture of transparency, collaboration, continuous learning, and quality ownership across R&D, PV, Medical, Regulatory, Technical Operations, Commercial, and external partners. 

Qualifications 

• Bachelor’s degree in life sciences, pharmacy, nursing, biochemistry, chemistry, biotechnology, or a related field required; advanced degree (MS, PharmD, PhD, MPH, or equivalent) preferred. 

• 12+ years of progressive quality assurance, compliance, clinical operations, drug safety, regulatory, or development experience in biotechnology/pharmaceuticals for Senior Director level; 15+ years for Executive Director level, or equivalent experience. 

• Significant leadership experience in GCP, GLP/GCLP, and/or GVP/GPV quality oversight in a regulated clinical development environment. 

• Demonstrated success establishing, scaling, or maturing quality systems, audit programs, vendor oversight programs, CAPA programs, inspection readiness programs, and quality metrics in an outsourced or hybrid operating model. 

• Proven experience leading or supporting global regulatory inspections, including direct interaction with health authorities and management of inspection responses, commitments, and follow-up activities. 

• Experience supporting clinical development, regulatory submissions, and product lifecycle milestones such as INDs, CTAs, NDA/BLA/MAA submissions, approvals, launch readiness, and post-authorization obligations. 

• Strong knowledge of clinical trial operations, data integrity, eTMF, EDC, CTMS, safety databases, computerized system validation/assurance, Part 11, and Annex 11 expectations. 

• Oncology, ADC, biologics, immuno-oncology, or other complex therapeutic modality experience preferred. 

• Direct experience with European product launch, EU pharmacovigilance system readiness, QPPV/PSMF governance, local safety contacts, affiliate/distributor oversight, or EU PV inspections preferred. 

Knowledge and Skills 

• Deep knowledge of global clinical quality and pharmacovigilance requirements, including ICH GCP, FDA GCP/GLP/PV-related regulations, EU Clinical Trials Regulation, EU GVP modules, OECD GLP principles, MHRA expectations, and other applicable regional requirements. 

• Strong strategic quality leadership skills, with the ability to set vision, governance, metrics, priorities, and risk-based operating models while remaining close enough to the work to resolve critical issues. 

• Proven inspection leadership capabilities, including preparing teams, managing inspection logistics, coaching SMEs, triaging requests, supporting front-room/back-room processes, leading responses, and closing commitments. 

• Demonstrated ability to influence executives, cross-functional leaders, vendors, and partners while balancing regulatory rigor with pragmatic, phase-appropriate implementation. 

• Excellent written and verbal communication skills, with the ability to simplify complex quality and regulatory issues for senior leadership, auditors, inspectors, and cross-functional teams. 

• Strong project management, organizational, analytical, and problem-solving skills with the ability to manage multiple priorities in a fast-paced, dynamic biotech environment. 

• Demonstrated success building teams, developing talent, managing external experts, and creating a practical quality culture that enables compliant execution.