Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

About the Role

This role delivers strategic GCP quality oversight across Denali's clinical trial portfolio, anchoring inspection readiness, risk-based quality decision-making, and continuous improvement of the GCP Quality Management System. It provides strategic leadership in quality risk management, inspection readiness, Sponsor oversight, and continuous improvement across the clinical development lifecycle, setting the standard for compliance and ethical conduct. The role shapes the evolution of Denali's quality systems as the clinical portfolio grows, exercising independent judgment on complex compliance matters.

Responsibilities

Lead GCP quality strategy on assigned Study Execution Teams (SETs), establishing a cohesive framework across Denali's clinical trials.
Partner with the Zurich Site Lead and cross-functional leaders to drive site-level quality maturity and operational excellence.
Lead proactive quality risk assessments and drive risk mitigation strategies throughout study execution.
Own risk-based monitoring and analysis of quality issues, delivering strategic guidance aligned with ICH-GCP and applicable global regulations.
Lead Sponsor inspection strategy, inspection management, regulatory interactions, inspection response activities, and CAPA effectiveness.
Identify quality and compliance gaps, direct root cause analysis, and drive CAPA development to resolution.
Oversee CAPA implementation, effectiveness reviews, and continuous improvement activities.
Lead evaluation, selection, and ongoing quality oversight of CROs and clinical vendors.
Design and continuously improve GCP Quality Systems, SOPs, and the broader Quality Management System.
Lead development of inspection strategy documents, study storyboards, and inspection readiness tools.
Own QA review of essential clinical trial documents and lead implementation of internal GCP QA processes and tools.
Represent Clinical Quality Assurance in cross-functional initiatives, championing a culture of compliance, ethics, and patient safety across clinical programs.

Requirements

Experience developing, implementing, or improving Quality Management Systems.
Working knowledge of ICH E6 GCP guidelines, FDA Code of Federal Regulations, and other applicable global regulations.
Demonstrated experience supporting or leading regulatory inspections (FDA, EMA, MHRA or other global regulatory authorities).
Demonstrated experience providing quality oversight of CROs, vendors, laboratories, and other outsourced clinical service providers.
Demonstrated ability to influence cross-functional teams and lead strategic quality initiatives in a matrix organization.
Experience implementing ICH E6(R3) Quality by Design and Quality Risk Management principles.

Skills

Excellent communication and presentation skills with demonstrated ability to communicate complex quality issues to senior leadership and regulatory inspectors.
Strong critical-thinking skills, with the ability to synthesize complex, ambiguous information from multiple sources to drive resolution.

Experience Level

12+ years of related experience

Education Level

Bachelor's degree

Salary/Compensations

$171,000.00 to $223,000.00

Benefits

401k
healthcare coverage
ESPP
a broad range of other benefits

About the Company

Denali is committed to its core company value of unity by creating a diverse and inclusive environment.

Equal Opportunity

We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.