The posting
About Absci
Absci is a clinical-stage biotechnology company advancing novel therapeutics using generative AI. Our Integrated Drug Creation™ platform combines cutting-edge AI models with a synthetic biology data engine, enabling the rapid design of innovative therapeutics that address challenging therapeutic targets.
Absci is a global company headquartered in Vancouver, WA, and maintains offices in New York City, Switzerland, and Serbia. Learn more at www.absci.com http://www.absci.com or follow us on LinkedIn (@absci https://www.globenewswire.com/Tracker?data=QKz5HZjFLFcFlte0YrrQC2_RZ9jEfBFXR4U86Ihyw5yW5l0TJ95wXGFPNkalvX5xK_1tEI7VNfv2YrNozFsC63NWGGcJFFgkAi2YmFiJdyU=), X (@Abscibio https://www.globenewswire.com/Tracker?data=4f2_M87IaqlZJFPpkOQk1a253uTPOorDDdYHnQXguGq6ueEuvsZsV2iqFOgeQlUQ6K7ilz9v9z06zj1J7J095A==), and YouTube https://www.globenewswire.com/Tracker?data=pFUhTvaKrb8dfcipGtnwTLQqi0USS1LieKqGM4t6Vddl7ktIUkXqFv1wY4ZGCfxiynAyNI9n4LdC1YM1TwQcyE1K6LqS719bn4NSniK2Ab0=.
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.
A critical responsibility of this role is to bring a cross-functional Sponsor perspective to inspection readiness. The leader will proactively identify operational and compliance gaps, assess their potential impact, establish practical remediation plans, and drive issues to resolution in partnership with Clinical Operations, Quality, Regulatory, Data Management/Biometrics, Clinical Development, Development Services, and other relevant functions.
This leader reports directly to the Senior Vice President & Head of Global Clinical Operations and will serve as a senior subject-matter expert and operational partner across the development organization. The role requires the ability to operate strategically while remaining sufficiently hands-on to review processes and documentation, support study teams, and ensure sustained execution of inspection-ready practices.
Key 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 that supports Absci’s evolving clinical development portfolio.
- 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 http://ClinicalTrials.gov and other applicable public disclosure obligations, in partnership with Regulatory, Clinical Development, Biostatistics/Data Management, and other stakeholders.
- 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, ensuring role-based training is current, documented, and inspection-ready.
- Review and assess clinical development SOPs, work instructions, plans, templates, and related controlled documents for clarity, consistency, regulatory alignment, appropriate Sponsor oversight, and operational practicality.
- Identify areas where new or revised SOPs, work instructions, standards, tools, or processes are needed and support development, implementation, training, and adoption.
- Partner closely with Data Management/Biometrics and other cross-functional teams to support operational quality, data integrity, inspection readiness, 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, including appropriate documentation of Sponsor oversight, decisions, escalations, risk management, and issue resolution.
- Evaluate CRO and vendor oversight practices and documentation to ensure Sponsor responsibilities, governance, escalation, performance management, and evidence of oversight are appropriately defined and documented.
- Establish inspection-readiness metrics, dashboards, risk indicators, and management routines that provide visibility into compliance health, emerging risks, remediation status, and readiness across the portfolio.
- Lead or coordinate periodic inspection-readiness reviews, mock inspections, gap assessments, and targeted deep dives, and ensure resulting observations and actions are tracked through closure.
- Support preparation for and execution of regulatory inspections and Sponsor audits, including inspection planning, document readiness, interview preparation, response coordination, and post-inspection remediation, as applicable.
- Partner with Quality to ensure appropriate alignment between Clinical Operations execution and the company Quality Management System while maintaining clear functional ownership and accountability.
- Monitor evolving ICH-GCP expectations, applicable clinical trial regulations, regulatory inspection trends, and industry best practices and translate them into practical improvements to clinical operations processes and oversight.
- Promote a culture of quality, accountability, operational discipline, continuous improvement, and proactive inspection readiness across study teams and functions.
- Provide senior-level coaching and guidance to study teams and functional stakeholders on GCP compliance, inspection readiness, documentation practices, and operational excellence.
- Support strategic initiatives across Global Clinical Operations and the broader development organization where strong cross-functional operational and compliance leadership is required.
- Up to 20–30% domestic and international travel, as required.
Qualifications & Preferred Skills
- Bachelor’s degree in life sciences or a related field; advanced degree preferred.
- 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 http://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.
Leadership Profile
The successful candidate will be a pragmatic, highly experienced clinical operations leader who combines deep GCP and inspection-readiness expertise with a strong understanding of how clinical trials are actually executed. They will bring an enterprise-wide Sponsor perspective, identify risks before they become inspection findings, and work collaboratively across functions to establish practical and sustainable solutions. This individual will be comfortable challenging existing practices when needed, driving accountability without creating unnecessary bureaucracy, and building an enduring culture in which inspection readiness is embedded in day-to-day clinical trial execution rather than treated as a periodic exercise.
AbSci offers highly competitive salaries and benefits, including medical and dental insurance, paid time off, and 401(k) with a generous company match.
Legal authorization to work in the United States is required. Absci is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, sexual orientation, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, marital status, or any characteristic protected under applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which they have applied should make a request to the recruiter or hiring manager, or contact [email protected].
