Get daily remote job opportunities in your inbox

No middlemen, no spam, no infinite scrolling.

Get relevant job opportunities, one email at a time.

Unsubscribe at any time.

Back to Remote jobs  >   All others
Director of Quality Compliance and Risk Management @Kyverna

[Hiring] Director of Quality Compliance and Risk Management @Kyverna

Apr 05, 2025 - Kyverna is hiring a remote Director of Quality Compliance and Risk Management. 💸 Salary: $195,000 to $235,000 usd annually, plus bonus and stock options. 📍Location: USA.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.

Role Description

This role involves leading and evolving our global quality compliance strategy as the Director of Quality Compliance and Risk Management. You will shape the inspection readiness program, lead audits, and elevate the compliance culture across Kyverna’s development and manufacturing platforms.

  • Design and implement scalable, risk-based quality compliance and auditing programs across global operations.
  • Build and lead cross-functional inspection readiness teams to ensure end-to-end regulatory preparedness.
  • Define the quality roadmap to support clinical and commercial development goals.
  • Lead domestic and international audits of internal functions, suppliers, and contract manufacturing/testing partners.
  • Manage contracted and internal auditors in the execution of the audit plan and inspection readiness activities.
  • Manage all stages of the audit lifecycle: resourcing, scheduling, planning, reporting, follow-up, CAPA management, and closure.
  • Conduct due diligence assessments and develop vendor risk mitigation strategies in collaboration with external quality and operations.
  • Develop and maintain systems to monitor and reduce compliance risks while ensuring data integrity.
  • Ensure alignment with FDA, EMA, and ICH regulations, with a focus on advanced biologics and genetically modified cell therapies.
  • Support investigations and implement corrective/preventive actions (CAPA) across the product lifecycle.
  • Serve as a subject matter expert on global compliance requirements and industry trends.
  • Guide and mentor a team of quality professionals; manage cross-functional collaboration with regulatory, clinical, technical, supply chain, and patient operations teams.
  • Support continuous improvement of SOPs, audit templates, and training programs to mature Kyverna’s Quality Management System (QMS).

Qualifications

  • 10+ years of experience in GxP quality compliance in the pharmaceutical or biotechnology sector, with at least 5 years in biologics or cell/gene therapy.
  • BS/MS/PhD in life sciences, pharmacy, or related field.
  • Extensive knowledge of applicable regulatory frameworks: FDA (21 CFR Parts 11, 210, 211, 600+), EMA, ICH, EudraLex Volume 4, PIC/S, and ISO/USP standards.
  • Skilled auditor with proven experience conducting global supplier and internal audits.
  • Strong understanding of biologics manufacturing, QC, and QA processes.
  • Demonstrated ability to lead cross-functional initiatives and mentor QA teams.
  • Excellent communication, analytical thinking, and project management skills.
  • Ability to work in a fast-paced, matrixed environment while balancing compliance, business needs, and innovation.

Requirements

  • The salary range for candidates residing in California for this position is $195,000 USD to $235,000 USD annually.
  • This position is also eligible for bonus, benefits, and participation in Company’s stock option plan.

Benefits

  • Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.
  • Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status.

Similar Remote Jobs

More jobs at Kyverna

More All Others jobs

More jobs in USA

Kickstart Your Job Search

Need advice to apply? Join our free Webinar « 3 Mistakes to Avoid When Looking For A Remote Startup Job (And What To Do Instead) »
Register for free

Unlock 54,436 additional remote jobs, advanced search & email notifications

Get Access Now

Too many emails? Declutter your inbox with Meco

Your home for reading newsletters

Try for free - no card required.
Before You Apply
️
📍 Be aware of the location restriction for this remote position: USA
‼ Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.
Back to Remote jobs  >   All others
Director of Quality Compliance and Risk Management @Kyverna
All others
Salary 💸 $195,000 to $235,000 usd annually, plus bonus and stock options
Remote Location
USA
Job Type full-time
Posted Apr 05, 2025
Apply for this position Unlock 54,436 Remote Jobs
️
📍 Be aware of the location restriction for this remote position: USA
‼ Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.
Director of Quality Compliance and Risk Management Apply for this position Unlock 54,436 Remote Jobs
×
  • Unlock 54,436 hidden remote jobs.
  • Your shortcut to remote work. Apply before everyone else.
  • Click and apply. No middlemen, no hassle.
Remotive - Email digest of tips on remote work and productivity | Product Hunt

We’re not like the other sites. Come see why!

50% off in April 2025
  • Single payment
  • Lifetime access
  • Filter by location/skills/salary…
  • Create custom email alerts
  • Private Slack Community

Get relevant job opportunities in your inbox

    Remotive
    Find Remote Jobs
    Hiring Remotely
    Quick Access