Senior Director, Clinical Quality & Compliance

Denali Therapeutics; South San Francisco (CA); In loco; USD 245.000 - 318.000; Tempo pieno

Vantaggi offerti da questo lavoro

401k

Healthcare coverage

ESPP

Descrizione del lavoro

Denali Therapeutics Inc. is seeking a Senior Director, Clinical Quality to safeguard scientific and regulatory integrity across the clinical portfolio. You will set the GCP/GCLP quality strategy, drive inspection readiness, and scale the quality organization to support growth across functions.

You will lead audit programs, CAPA governance, and eTMF oversight, while mentoring managers and partnering with Regulatory Affairs, Clinical Operations and IT to align quality with program goals.

Competenze

• Bachelor’s degree with 12+ years of GCP/quality experience.
• 10+ years of people management experience.
• Advanced degree in health/science-related discipline preferred.
• Expert knowledge of ICH E6(R2) GCP guidelines, FDA CFR, and other global regulations.

Mansioni

• Set enterprise-wide GCP/GCLP compliance strategy and quality vision across clinical functions.
• Lead and develop the Clinical Quality organization and manage senior staff.
• Own the GCP/GCLP audit program across CROs, labs, sites, and documentation.
• Escalate and resolve enterprise-level quality risks with Regulatory Affairs and IT leadership.
• Drive CAPA and Deviation governance to address systemic issues.
• Oversee eTMF quality to ensure inspection-ready documentation.
• Lead development and enterprise-wide SOP implementation.
• Provide quality metrics and risk assessments to senior management.
• Prepare for Sponsor and Health Authority inspections as executive point of contact.

Conoscenze

GCP expertise

ICH E6(R2) knowledge

Regulatory inspections

Quality leadership

Audit programs

Cross-functional influence

Formazione

Bachelor’s degree in health/science

Advanced degree preferred

Descrizione del lavoro

Denali Therapeutics Inc. is seeking a Senior Director, Clinical Quality to safeguard scientific and regulatory integrity across the clinical portfolio. You will set the GCP/GCLP quality strategy, drive inspection readiness, and scale the quality organization to support growth across functions.

You will lead audit programs, CAPA governance, and eTMF oversight, while mentoring managers and partnering with Regulatory Affairs, Clinical Operations and IT to align quality with program goals.