Associate Director, Risk Management

Denali Therapeutics; South San Francisco (CA); Vor Ort; USD 150.000 - 190.000; Vollzeit

Benefits dieser Stelle

401k

Healthcare coverage

ESPP

Zusammenfassung

Scorpion Therapeutics in South San Francisco, CA is seeking a senior GCP QA leader to drive quality oversight across clinical development programs, ensuring compliance with ICH E6, GVP, and FDA regulations.

You will lead deviations, CAPAs, and risk management initiatives while mentoring teams and partnering with study teams to embed QbD and RBQM into processes, with a focus on inspection readiness and continuous improvement.

Qualifikationen

• Requires 12+ years GCP QA experience with bachelor’s degree, 10+ with master’s, or 7+ with PhD.
• Expertise in ICH E6, GCP, FDA regs and global requirements.
• Experience with QbD, RBQM, and QMS in clinical development.
• Proven leadership of GCP deviation, CAPA, and vendor qualification in a GxP environment.
• Strong analytical, communication, and cross-functional collaboration skills.

Aufgaben

• Lead GCP deviation and CAPA processes with timely investigations and closure.
• Partner with study teams to assess and mitigate quality risks using QbD and RBQM.
• Serve as SME on GCP quality risk management and noncompliance resolution.
• Oversee Clinical Trial Risk Tracking Program and escalation of risks.
• Analyze data, identify trends, and report insights to leadership.
• Review deviations and events to drive systemic improvements.
• Lead vendor qualification and ongoing GCP quality oversight.
• Support regulatory inspections with inspection readiness and responses.
• Enhance QMS by improving risk management processes and tools.

Kenntnisse

GCP QA leadership

ICH E6/GCP expertise

QMS & RBQM

Vendor qualification

Risk management

Cross-functional influence

Regulatory communications

Ausbildung

Bachelor’s degree in life sciences

Master’s degree in related field

PhD in life sciences

Tools

GxP systems

Quality management software

Jobbeschreibung

Key Accountabilities / Core Job Responsibilities:

• Lead the GCP deviation and CAPA processes, ensuring timely investigation, implementation, effectiveness verification, and closure.
• Partner with study teams to identify, assess, and mitigate quality risks across clinical development programs using Quality by Design (QbD) and risk-based quality management principles.
• Serve as the subject matter expert on GCP quality risk management, guiding detection, investigation, documentation, and resolution of GCP noncompliance.
• Maintain quality oversight of the Clinical Trial Risk Tracking Program, ensuring risks are documented, monitored, and escalated.
• Analyze quality and compliance data, identify trends, develop meaningful metrics, and communicate insights to leadership and cross-functional stakeholders.
• Review deviations, noncompliance, and quality events to identify systemic risks and drive continuous improvement.
• Lead GCP and GVP vendor qualification and ongoing quality oversight to ensure regulatory and company compliance.
• Support regulatory inspections and audits with inspection readiness, documentation review, response development, and follow-up.
• Enhance the Quality Management System (QMS) by improving quality risk management processes, tools, and best practices.

Qualifications / Skills:

• Bachelor’s with 12+ years GCP Quality Assurance experience; or Master’s with 10+ years; or PhD with 7+ years; or equivalent education/experience.
• Expertise in ICH E6 GCP, GVP, FDA regulations, and applicable global requirements.
• Experience with QbD, RBQM, and QMS principles in clinical development.
• Experience leading GCP deviation, CAPA, vendor qualification, and quality risk management in a GxP environment.
• Strong analytical/critical thinking skills for risk evaluation and trend identification.
• Excellent written, verbal, and interpersonal communication; ability to influence cross-functionally without direct authority.
• Ability to manage multiple priorities in a fast-paced environment with high quality and attention to detail.

Benefits:

• Competitive total rewards package including 401k, healthcare coverage, and ESPP.