Senior Director, Inspection Readiness & GCP Compliance

Absci Corp.; United States, Northern America, Americas; Hybrid; USD 180,000 - 280,000; Full time

Job summary

Absci Corp. is seeking a Senior Director, Inspection Readiness to lead sponsor-level oversight for GCP compliance and inspection readiness across Absci’s clinical program.

The role blends strategic leadership with hands-on process review to ensure study documentation and systems withstand regulatory inspections. You will collaborate with Quality, Regulatory, Data Management/Biometrics, and Clinical Development to identify gaps, remediate risks, and drive continuous improvement in trial

Qualifications

• 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, 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.

Responsibilities

• Provide Sponsor-level leadership for inspection readiness and GCP compliance across clinical studies and programs.
• Develop, implement, and maintain a risk-based, scalable inspection readiness framework for Absci’s portfolio.
• Assess inspection readiness of studies and processes, including documentation quality, Sponsor oversight, issue management, and data integrity.
• Identify compliance gaps, evaluate risk, and partner with functions to remediate and implement preventive actions.
• Coordinate cross-functional oversight of clinical trial registration and results reporting with Regulatory and Clinical Development teams.
• Establish processes for tracking reporting requirements, timelines, and evidence of compliance.
• Maintain training requirements and matrices to ensure current, inspection-ready documentation.
• Review SOPs and controlled documents for clarity, regulatory alignment, and practicality.
• Identify needs for new SOPs or tools and support deployment and adoption across functions.
• Oversee TMF readiness and sponsor oversight documentation; coordinate with Quality and Regulatory partners.
• Support CRO/vendor oversight to ensure governance and performance management.
• Establish inspection-readiness metrics and dashboards for portfolio visibility.
• Lead or support mock inspections, gap assessments, and close-out actions.
• Prepare for regulatory inspections and sponsor audits, including document readiness and response coordination.
• Promote a culture of quality and operational discipline across study teams.
• Provide coaching on GCP compliance and inspection readiness to stakeholders.
• Support cross-functional strategic initiatives requiring operational leadership.
• Travel up to 20–30% domestically and internationally.

Skills

GCP compliance

Inspection readiness

Cross-functional leadership

Regulatory affairs

Sponsor oversight

Quality management

Documentation control

Risk management

Strategic planning

Training & mentoring

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Job description

Absci Corp. is seeking a Senior Director, Inspection Readiness to lead sponsor-level oversight for GCP compliance and inspection readiness across Absci’s clinical program.

The role blends strategic leadership with hands-on process review to ensure study documentation and systems withstand regulatory inspections. You will collaborate with Quality, Regulatory, Data Management/Biometrics, and Clinical Development to identify gaps, remediate risks, and drive continuous improvement in trial