Senior Director, Inspection Readiness

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $250k - $325k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 0%

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Absci

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2011

🧬 Biotechnology

🤖 Artificial Intelligence

💊 Pharmaceuticals

Biotechnology • Artificial Intelligence • Pharmaceuticals

Absci is a biotechnology company that uses generative artificial intelligence together with wet-lab validation to design de novo biologics, primarily antibodies. Its integrated AI Drug Creation Platform performs data generation, model training, de novo design, multi-parametric lead optimization, and AI-enabled target discovery (using reverse immunology) to uncover novel antibody/target pairs and accelerate IND-enabling studies. Absci advances internal and partnered therapeutic programs—such as ABS-201, a designed antibody targeting prolactin receptors for androgenetic alopecia—and emphasizes rapid iterative cycles between AI and lab work to shorten biologics discovery timelines.

📋 Description

• Provide Sponsor-level leadership for inspection readiness and GCP compliance across clinical studies, programs, and functional areas • Develop, implement, and maintain a risk-based inspection readiness framework • Assess clinical study and operational-process readiness, including documentation, Sponsor oversight, issue management, data integrity, and regulatory adherence • Identify compliance, process, documentation, and oversight gaps and drive remediation and preventive actions • Oversee clinical trial registration and results-reporting requirements, including ClinicalTrials.gov • Track reporting requirements, accountabilities, timelines, supporting documentation, and compliance evidence • Assess clinical development training requirements and training matrices • Review and improve SOPs, work instructions, plans, templates, and controlled documents • Support development, implementation, training, and adoption of new or revised processes • Partner with Data Management/Biometrics and cross-functional teams on operational quality, data integrity, issue resolution, and database-lock readiness • Support inspection-ready Trial Master Files and essential records • Evaluate CRO and vendor oversight practices and documentation • Establish inspection-readiness metrics, dashboards, risk indicators, and management routines • Lead or coordinate mock inspections, gap assessments, and targeted deep dives • Support regulatory inspections and Sponsor audits, including planning, document readiness, interview preparation, response coordination, and remediation • Partner with Quality to align Clinical Operations execution with the Quality Management System • Monitor evolving ICH-GCP expectations, regulations, inspection trends, and industry best practices • Promote quality, accountability, operational discipline, continuous improvement, and proactive inspection readiness • Provide senior-level coaching and guidance on GCP compliance, inspection readiness, documentation, and operational excellence • Support strategic initiatives across Global Clinical Operations and the broader development organization • Travel domestically and internationally up to 20–30% as required

🎯 Requirements

• Bachelor’s degree in life sciences or a related field • 15+ years of clinical operations, clinical quality, or related drug-development experience • 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 • 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 • 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 • Strong knowledge of TMF requirements and inspection-ready documentation practices • Experience partnering with Data Management/Biometrics, Regulatory, Quality, Clinical Development, Safety, and other functions • Strong CRO and vendor oversight experience • Ability to operate effectively in a small, fast-paced, growth-oriented biotechnology or pharmaceutical environment • Strong cross-functional leadership and ability to influence senior stakeholders and drive accountability without direct authority • Excellent written and verbal communication skills, executive presence, sound judgment, and 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 • Legal authorization to work in the United States

🏖️ Benefits

• Medical insurance • Dental insurance • Paid time off • 401(k) with a generous company match • Equity • Bonus