QA/RA Project Manager
DeepHealth
Director, Risk Based Quality Management
Gilead Sciences
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $191,250 - $247,500 per year
Job Level
Lead
About the role
- Lead Subject Matter Expert and Process Owner for RBQM areas, processes, and technologies.
- Lead collaborations with CRO partners to ensure continuous improvement and alignment with Gilead’s RBQM framework, including representing RBQM in governance committees.
- Provide oversight of vendors performing RBQM activities, ensuring effective, high quality, and timely delivery of portfolio requirements.
- Support inspection-readiness and participate in audits and regulatory inspections, serving as a point of contact for RBQM.
- Study Risk Assessment and Mitigations
- Provide expert guidance, training, and support on RBQM in clinical trials, ensuring adherence to ICH GCPs, regulatory requirements, and internal processes.
- Advise study teams throughout risk management activities, fostering cross-functional collaboration, and promoting excellence in risk management.
- Contribute to the development of new central monitoring tools to address risks and support study oversight, Contribute to the identification and definition of Quality Tolerance Limits, risks, thresholds, mitigations, performance indicators, and develop the study’s Central Monitoring plan.
- Participate in determining monitoring strategies and mitigation plans aligned with study and site risks, including authoring the Central Monitoring Plan.
- Facilitate cross-functional risk review meetings with study teams, collaborating in risk signal interpretation and triage, ensuring effective communication and resolution of issues.
- Oversee timely resolution of risk signals and issues identified through central monitoring, ensuring appropriate escalation and documentation.
- Operational Excellence
- Lead the development, enhancement, and implementation of RBQM processes, systems, templates, tools, and training materials to support operational efficiency and scalability.
- Manage RACT libraries, driving consistency across programs and therapeutic areas.
- Lead or actively contribute to cross-functional committees, projects and workstreams focused on continuous improvement and innovation.
- Develop and analyze RBQM performance metrics to assess compliance, effectiveness, and areas for optimization.
- Serve as a champion for change initiatives by fostering an innovative mindset, bridging RBQM knowledge across functions, and promoting new ideas, best practices, and modern ways of working.
- Build and maintain strong partnerships with service providers, influencing strategic relationships and ensuring high-quality deliverables.
- Represent Gilead in industry-wide collaborations, contributing thought leadership and sharing best practices.
- Stay current with RBQM-related regulations, trends, and industry standards to continuously improve the RBQM framework, processes, technologies, oversight, and compliance.
Requirements
- Bachelor’s degree with 12+ years of clinical research experience in the biotech or pharmaceutical industry (e.g., clinical development, site management, site monitoring, clinical operations, or data management) or a Master’s/Doctoral degree with 10+ years of clinical research experience Or 8 years of relevant experience with a PhD.
- Minimum of 5 years of experience in RBQM and central monitoring
- Minimum of 1 year of experience as a Clinical Research Associate or Study Coordinator
- Minimum of 2 years of line management experience
- Demonstrated experience across multiple phases of clinical development and therapeutic areas
- Strong leadership presence with the ability to lead without authority and influence stakeholders across functions, cultures, and geographies
- Deep expertise in RBQM strategies, processes, tools, and implementation
- Proven success in managing large-scale global programs and projects
- Strong negotiation and conflict resolution skills
- Demonstrated ability to hire, manage, and develop diverse top talent
- Effective in proactively managing organizational change and driving innovation
- Expert-level proficiency in Microsoft Office applications
- Excellent verbal, written, and presentation communication skills
- Fluent in English, both written, spoken
- Strong interpersonal skills and understanding of team dynamics; able to build and maintain strong relationships
- High cross-cultural competency and global collaboration experience
- Strategic thinker with strong analytical and problem-solving skills; highly attentive to detail and skilled in data analytics
- Ability to quickly absorb study design and therapeutic area knowledge; think critically to identify risks, interpret data trends, and manage issues
- Outstanding organizational and time management skills; able to work independently, manage competing priorities, and deliver results on time and within budget
