Apply on Employer Site

Alumis · 4 days ago

Head of GCP Compliance

South San Francisco, CA

Full-time

Hybrid

Director/Executive

$225K/yr - $295K/yr

10+ years exp

Alumis Inc. is a precision medicines company focused on transforming the lives of patients with autoimmune diseases. The Head of GCP Compliance will lead the GCP compliance strategy, ensuring that all clinical development activities meet global regulatory and ethical requirements while overseeing the GCP Compliance team and fostering a culture of quality and integrity.

BiotechnologyHealth CareLife ScienceMedicalPrecision Medicine

Responsibilities

Direct and oversee the company’s 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

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

Ensure GxP systems are appropriately designed, validated, implemented, and maintained, with strong controls around data integrity, audit trails, and deviation/CAPA processes

Partner with QA in representing the voice of quality and building the culture of quality and compliance in Development

Develop and deliver GCP training programs for internal teams and external partners to champion a quality-first mindset, reinforcing consistent compliance behaviors

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

Oversee compliance considerations for digital health tools, eClinical platforms, and AI-enabled trial solutions

Develop and publish metrics and KPIs to keep the Development leaders informed of key risk indicators and efficiencies efforts

Qualification

GCP compliance strategyICH-GCP knowledgeFDA regulationsEMA regulationsQuality Assurance collaborationRisk assessmentTraining program developmentLeadership experienceCommunication skillsStrategic thinkingCollaborative leadershipAdaptability