Risk Management Director jobs in Daly City, CA

POSITION SUMMARY

Reporting to the Vice President, Regulatory Affairs, CARGO is hiring a Director, Clinical Quality & Risk Management to help build our emerging Clinical Quality Assurance (CQA) organization and support all functions within Clinical Development. This position includes operational quality management and inspection management activities.

The successful candidate will work cross-functionally to develop and implement quality systems and processes to meet all US, EU and potentially global, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance (GVP) requirements. This individual will also develop needed infrastructure and processes needed to support corresponding Clinical Quality activities.

The role is based in San Mateo, CA but is also suitable for a hybrid or remote work arrangement.

WHAT YOU’LL DO AT CARGO THERAPEUTICS

• Develop and implement GCP, GLP quality systems in accordance to ICH, FDA, EMA and global competent authority regulations and industry guidance
• Prepare and implement audit plans and audit CAPAs for all CROs, testing and animal laboratories, clinical sites, and internal CARGO departments
• Lead and ensure inspection readiness activities for all internal and external entities
• Lead and host GCP, GLP, GVP inspections. Follow up to any responses and CAPAs
• In collaboration with Quality colleagues outside of regulatory, develop, implement and manage the deviation and CAPA systems
• Lead the creation, development, and implementation of QRM and Quality by Design (QbD), and a to-be-identified Quality Management System (QMS) electronic system to ensure phase-appropriate compliant drug development for all therapeutic areas
• Develop the GCP QA organizational strategy and lead/mentor the respective teams
• Develop & maintain a systematic Quality Risk Management program for key risks across clinical development including identification & prioritization of risks and mitigations plans e.g. biomarkers, submissions, inspections, regulatory reporting, public disclosure, pharmacovigilance, drug supply delivery, outsourcing, Anti-Bribery Anti-Corruption, Corporate Integrity Agreement, data integrity, management of human biological samples, data disclosure, privacy and GCP, as well as interactions with external parties (CROs, external partners, regulatory agencies, etc.).
• Promote development of a quality culture framework & standards including the embedding of risk management principles.
• Lead and facilitate implementation of quality improvements and ensure business critical quality improvements are adequately resourced to deliver.
• Ensure Corrective Actions Preventative Actions (CAPAs) are implemented, and learnings shared by partnering with study teams, Clinical Leadership Team and the various functional areas.

THE RIGHT STUFF: Required Experience & Qualifications

• Minimum of Bachelor’s degree in a scientific, medical or clinical discipline with 3 years’ as a Director in clinical quality
• Relevant experience in quality and compliance governance and risk management in the biopharmaceutical or related industry
• Extensive knowledge of worldwide GCP regulatory requirements, industry practices, and ability to apply concepts as well as experience with GDP, GVP and GLP
• Deep understanding of the PhRMA code regulations, standards, and business requirements
• Experience in crafting and implementing quality systems and risk management tools
• Experience leading/hosting US and international health authority inspections/interactions
• Expertise in working autonomously with strong interpersonal, verbal, and written communication skills in a collaborative work environment
• Skillful in prioritizing and multi-tasking in a fast-paced environment
• Excellent time management skills and a proven ability to work on multiple projects at any given time

• Advanced degree preferred
• Therapeutic experience in biologics, specifically cell therapy, preferred

PAY RANGE*

The combined pay range for the Director, Clinical Quality & Risk Management is from $190,369-$261,758. * Title and salary will be based on our assessment of skills and experience relevant to our needs for the role.

ABOUT CARGO THERAPEUTICS

CARGO Therapeutics is engineering best-in-class CAR T-cell therapy to overcome resistance to cancer treatment and address barriers to access so that more patients may benefit from potentially curative therapies. CARGO is on a mission to outsmart cancer by advancing a new generation of best-in-class chimeric antigen receptor (CAR) T-cell therapies. Despite advances made by commercially available autologous CARs, these treatments are curative for fewer than half of all cancer patients. In addition, far too many patients are unable to access these potentially curative therapies due to other challenges, including manufacturing, supply constraints, slow turnaround time and reimbursement hurdles. The team at CARGO is intensely focused on pursuing novel solutions to achieve better cancer treatment outcomes and experiences.

Our founders are pioneers and world experts in CAR T cell therapy, and we have built a team with experience and success developing, manufacturing, launching and commercializing oncology and cell therapy products. CARGO Therapeutics colleagues share a passion to help others thrive. We are tenacious in the relentless pursuit of our mission, and we innovate to change the game for the patients we serve.

Join us to help make a difference!

EEO & EMPLOYMENT ELIGIBILITY CARGO Therapeutics, Inc. is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. CARGO Therapeutics, Inc. also complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requires of applicable law.

CARGO Therapeutics requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at CARGO Therapeutics, and it applies regardless of whether the position is located at a CARGO Therapeutics site or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.