Senior Manager, Quality Risk Management
Denali Therapeutics
Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.
The Opportunity
Denali is seeking a Senior Risk Manager, reporting to the Director of Development Quality, to join our team. You will be responsible for working with GCP Quality colleagues and study teams to identify, assess, and mitigate quality risks across all Denali clinical trials. By focusing on the critical-to-quality risks to patient safety and data integrity, you will work to promote a continued state of inspection readiness.
This individual must be able to work in a spirit of collaboration and service, while also operating with a high level of independent judgment. Denali is seeking candidates with a can-do attitude who work with the highest integrity, fostering an environment of compliance and continuous improvement.
Responsibilities
- Manage deviation and CAPA processes, driving CAPAs to timely completion and measuring effectiveness
- Maintains and reports quality and compliance metrics
- Reviews and trends GCP/GVP non-compliance across development programs
- Contributes to process refinement and improvement in support of inspection readiness activities
- Develop and edit procedural documents as needed
- Participates in inspection preparation and support activities
- Executes and owns the GCP/GVP vendor qualification process
- Provides insight into the management of GCP/GVP quality issues
- Serves as an advisor to fellow operational and QA colleagues
Skills & Experience
- 6+ years working in GCP QA
- Flexibility to adapt to the dynamic needs of a growing company
- Knowledge and understanding of RBQM
- Excellent written and verbal communication skills Working knowledge of ICH E6 GCP guidelines, FDA Code of Federal Regulations, and other global applicable laws and regulations
- Experience applying risk-based methodology and working within the QMS framework
- Knowledge of quality systems and processes
- Attention to detail and accuracy in work, while delivering on deadline
- Critical thinker with ability to synthesize information from multiple sources and apply to problem-solving
- Able to work across multiple projects and prioritize tasks as required
- Skilled at partnering and guiding cross-functional teams
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. 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.
Salary Range: $165,000 to $198,333. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
*This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
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