Head of GCP Compliance

Role Summary

The Head of GCP Compliance will lead Alumis’s Good Clinical Practice (GCP) compliance strategy and partner closely with Quality Assurance to ensure that all clinical development activities meet global regulatory and ethical requirements. This leader will oversee the GCP Compliance team, shape end-to-end compliance processes, and collaborate across Development to drive a culture of quality, integrity, and inspection readiness.

Responsibilities

• Strategic Leadership: Direct and oversee the company‚Äôs GCP compliance function, policies, and procedures in alignment with ICH-GCP, FDA, EMA, and other applicable regulations.
• Build and maintain resources and capabilities, infrastructure and deliverables, cross-functional relationships, processes, KPIs, metrics and progress reports.
• Study Oversight: Partner with this business to support ongoing audits and regulatory inspections.
• Lead proactive inspection-readiness activities across all clinical programs.
• Partner with QA on GCP on risk assessments, mitigation planning, and continuous improvement of compliance controls.
• Systems Oversight: Ensure GxP systems are appropriately designed, validated, implemented, and maintained, with strong controls around data integrity, audit trails, and deviation/CAPA processes.
• Quality Mindset: Partner with QA in representing the voice of quality and building the culture of quality and compliance in Development.
• Training & Culture: Develop and deliver GCP training programs for internal teams and external partners to champion a quality-first mindset, reinforcing consistent compliance behaviors.
• Cross-Functional Collaboration: Partner with Development Operations, Biometrics, Pharmacovigilance, QA, and Regulatory Affairs to proactively identify and mitigate compliance risks.
• Partner on initiatives that maintain high procedural compliance across clinical programs.
• Partner with QA in the management of process deviations, CAPAs and audit/inspection finding resolution and close out.
• Emerging Technologies: Oversee compliance considerations for digital health tools, eClinical platforms, and AI-enabled trial solutions.
• Metrics & Reporting: Develop and publish metrics and KPIs to keep the Development leaders informed of key risk indicators and efficiencies efforts.

Qualifications

• An advanced degree in Life Sciences, Pharmacy, or related field is preferred.
• 10+ years of experience in GCP quality/compliance, including 5+ years in a leadership role.
• Deep knowledge of ICH-GCP, FDA, EMA, and other global regulatory requirements.
• Proven success leading inspection readiness and serving as the primary interface with global health authorities during inspections and audits.
• Strong leadership, communication, and influencing capabilities.
• Experience in biotech or pharmaceutical industry, ideally in late-stage clinical development.
• Strategic thinking with operational execution skills.
• High integrity and commitment to ethical research practices; able to navigate complex regulatory and organizational environments.
• Collaborative and adaptable leadership style.
• Domestic/international travel (5-20%) may be required.

Skills

• GCP compliance and quality management
• Regulatory affairs liaison and inspection readiness
• Risk assessment and CAPA management
• Quality systems design and data integrity controls
• Cross-functional collaboration and program leadership
• Training program development and delivery

Education

• Advanced degree in Life Sciences, Pharmacy, or related field preferred

Additional Requirements

• Domestic/international travel as needed (5-20%)