Senior Director, Inspection Readiness

The Senior Director, Inspection Readiness leader is a senior, hybrid Clinical Operations professional who provides Sponsor-level leadership for inspection readiness, GCP compliance, and clinical trial operational excellence across Absci's clinical development portfolio. This individual will work across studies and functions to ensure that clinical trial processes, documentation, oversight, systems, and study conduct are maintained in a state of inspection readiness and can withstand regulatory inspection. The leader reports directly to the Senior Vice President & Head of Global Clinical Operations. Up to 20–30% domestic and international travel, as required. Absci is a clinical-stage biotechnology company advancing novel therapeutics using generative AI, headquartered in Vancouver, WA, with offices in New York City, Switzerland, and Serbia.

Responsibilities

Provide Sponsor-level leadership for inspection readiness and GCP compliance across clinical studies, programs, and relevant functional areas; Develop, implement, and maintain a risk-based, scalable inspection readiness framework; Assess the inspection readiness of clinical studies and operational processes, including documentation quality, Sponsor oversight, issue management, data integrity, and adherence to applicable procedures and regulatory requirements; Proactively identify compliance, process, documentation, and oversight gaps, evaluate risk and potential regulatory impact, and partner with accountable functions to establish, track, and complete remediation and preventive actions; Provide cross-functional Sponsor oversight and coordination of clinical trial registration and results-reporting requirements, including ClinicalTrials.gov and other applicable public disclosure obligations; Establish and oversee processes for tracking applicable reporting requirements, accountabilities, timelines, supporting documentation, and evidence of compliance; Partner with functional leaders to establish, maintain, and periodically assess clinical development training requirements and training matrices; Review and assess clinical development SOPs, work instructions, plans, templates, and related controlled documents; Identify areas where new or revised SOPs, work instructions, standards, tools, or processes are needed and support development, implementation, training, and adoption; Partner with Data Management/Biometrics and other cross-functional teams to support operational quality, data integrity, issue resolution, and readiness for key study milestones such as database lock; Support study teams in maintaining inspection-ready Trial Master Files and other essential records; Evaluate CRO and vendor oversight practices and documentation; Establish inspection-readiness metrics, dashboards, risk indicators, and management routines; Lead or coordinate periodic inspection-readiness reviews, mock inspections, gap assessments, and targeted deep dives, and ensure observations and actions are tracked through closure; Support preparation for and execution of regulatory inspections and Sponsor audits, including post-inspection remediation; Partner with Quality to align Clinical Operations execution with the company Quality Management System; Monitor evolving ICH-GCP expectations, clinical trial regulations, regulatory inspection trends, and industry best practices; Promote a culture of quality, accountability, operational discipline, continuous improvement, and proactive inspection readiness; Provide senior-level coaching and guidance to study teams and functional stakeholders on GCP compliance and inspection readiness; Support strategic initiatives across Global Clinical Operations and the broader development organization

Requirements

Bachelor's degree in life sciences or a related field; 15+ years of clinical operations, clinical quality, or related drug-development experience, with substantial direct experience in global clinical trial execution and inspection readiness; Deep knowledge of ICH-GCP, Sponsor responsibilities, applicable clinical trial regulations, quality systems, and regulatory inspection expectations; Demonstrated experience preparing for and supporting regulatory inspections, Sponsor audits, mock inspections, and inspection-readiness assessments; Strong understanding of end-to-end clinical trial operations across study start-up, conduct, monitoring, data management, safety interfaces, TMF, CRO/vendor oversight, database lock, closeout, and reporting; Experience with clinical trial registration and results disclosure requirements, including ClinicalTrials.gov, and the operational controls needed to support timely and compliant reporting; Demonstrated experience reviewing, developing, or improving SOPs, work instructions, controlled documents, training requirements, and operational processes; Experience assessing and remediating cross-functional compliance and operational gaps, with the ability to translate regulatory expectations into practical, sustainable processes; Strong knowledge of TMF requirements and inspection-ready documentation practices, including documentation of Sponsor oversight and decision-making; Experience partnering with Data Management/Biometrics, Regulatory, Quality, Clinical Development, Safety, and other functions on clinical trial compliance and operational readiness; Strong CRO and vendor oversight experience, including governance, performance management, escalation, risk management, and documentation of Sponsor oversight; Ability to operate effectively in a small, fast-paced, growth-oriented biotechnology or pharmaceutical environment and to create structure where processes are still evolving; Strong cross-functional leadership and demonstrated ability to influence senior stakeholders and drive accountability without direct authority; Excellent written and verbal communication skills, executive presence, sound judgment, and the ability to communicate complex compliance and operational issues clearly and pragmatically; Highly analytical, detail- and process-oriented, with strong project management, problem-solving, prioritization, and follow-through; Ability to operate strategically at the Sponsor and portfolio level while remaining hands-on enough to assess documentation, processes, and study-level execution; Legal authorization to work in the United States is required

Nice to have

Advanced degree preferred

Benefits

Highly competitive salaries; medical and dental insurance; paid time off; 401(k) with a generous company match