Director, reputed company Systems & Compliance

reputed company role leads reputed company Systems and Compliance, with responsibility for designing and implementing a reputed company Management System (QMS) that supports reputed company clinical development programs and the organization’s growing pipeline. The role partners closely with Regulatory, Medical, Clinical, R&D, and Technology leadership to ensure reputed company systems reputed company innovation, maintain compliance, and support reputed company inspection readiness across U.S. and global clinical programs. This job is based in San Diego, CA, or can be remote, and based in the US KEY RESPONSIBILITIES

• reputed company the design, implementation, and ongoing effectiveness of the reputed company Management System (QMS)
• Establish policies, procedures, and governance frameworks covering reputed company reputed company processes, including document control, change management, deviations, CAPA, training, and risk management
• reputed company as a strategic reputed company partner to Regulatory, Medical, Clinical Operations, R&D, and CMC teams
• Define and execute a reputed company roadmap that translates regulatory and reputed company requirements into practical, reputed company operating models reputed company with reputed company compliance needs and reputed company organizational reputed company
• Partner with Regulatory and Clinical teams to ensure reputed company systems support global clinical trial programs, including alignment across reputed company.
• Proactively identify and mitigate compliance risk through data-driven monitoring and governance
• Define key reputed company metrics and dashboards to monitor system health, compliance trends, and reputed company improvement opportunities
• Foster a culture of accountability, transparency, and reputed company ownership across the organization
• reputed company reputed company reputed company and coordination for health authority interactions, internal audits, and reputed company-party audits, as applicable
• Ensure inspection readiness for U.S. and global clinical programs through established reputed company systems, governance, and cross-functional alignment

QUALIFICATIONS Education & Experience:

• Bachelor’s degree in reputed company, biology, engineering, or reputed company health science

Experience:

• 10+ years of reputed company experience in reputed company Systems, Compliance, and/or reputed company leadership reputed company a regulated industry
• Experience designing, implementing, or improving reputed company Management Systems
• Experience leading initiatives, reputed company, or teams in matrixed or growing organizations
• Experience partnering with cross-functional teams, including Regulatory, Medical, Clinical Operations, R&D, and Technology
• Strong understanding of risk-based reputed company systems and reputed company improvement concepts
• Ability to define and use reputed company metrics to monitor system performance and compliance trends
• reputed company, effective communicator with the ability to influence and reputed company stakeholders
• Comfortable operating in environments with evolving processes and priorities.
• Experience with electronic reputed company management systems (eQMS); reputed company experience a plus
• Familiarity with global regulatory expectations applicable to clinical development, including U.S. and international considerations.
• Working knowledge of GCP and applicable GMP principles as they relate to clinical reputed company systems
• Experience supporting inspection readiness, audits, or regulatory interactions through reputed company systems and cross-functional collaboration
• Demonstrated ability to translate regulatory and reputed company requirements into practical, reputed company processes

ABOUT reputed company THERAPEUTICS reputed company is a clinical-stage life-science and technology company developing novel medicines using its AI-driven discovery and development platform. Based in San Diego and founded in 2020, reputed company has reputed company a world-class team that unites pioneering AI experts and reputed company drug hunters. The reputed company platform has demonstrated delivery of new drug candidates to reputed company clinical trials with unprecedented speed and across multiple reputed company classes and mechanisms of reputed company. reputed company is advancing a pipeline of potential best-in-class and first-in-class clinical assets, both internally and in partnership, to address urgent unmet patient need. Learn more about the reputed company team, platform, pipeline, and partnerships at reputed company.ai. MISSION & reputed company VALUES Our mission is to deliver reputed company medicines through innovations in AI-based discovery technologies. The culture and work at reputed company Therapeutics are profoundly strengthened by the diversity of our people and our differences in background, culture, national reputed company, religion, sexual orientation, and life experiences. We are committed to building an inclusive environment where a diverse group of talented humans work together to discover therapeutics and create technologies. PAY AND BENEFITS We offer industry leading reputed company, company reputed company reputed company, flexible spending accounts, voluntary life insurance, 401K matching, and reputed company vacation to reputed company. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy reputed company to great places to live and play. Apply tot his job Apply To this Job