JOB SUMMARY
This role will assist in leading activities within Quality Systems and Compliance, with responsibility for designing and implementing a Quality Management System (QMS) that supports current clinical development programs and the organization's growing pipeline. Quality Systems & Compliance partners closely with Regulatory, Medical, Clinical, R&D, and Technology leadership to ensure quality systems enable innovation, maintain compliance, and support continuous inspection readiness across U.S. and global clinical programs.
This position can be remote based in the US or hybrid based in our San Diego headquarters.
KEY RESPONSIBILITIES
- Execute and support ongoing effectiveness of the Quality Management System (QMS).
- Work closely with Quality management to manage deviations and investigations, CAPA, change controls, risk assessments, quality events, and effectiveness checks internally and while working with external partners and suppliers/vendors
- Create controlled documents and governance frameworks covering core processes from establishment throughout continuous improvement efforts
- Support regulatory compliance within drug production activities
- Execute a quality roadmap that translates regulatory and quality requirements into practical, scalable operating models aligned with current compliance needs and future organizational growth
- Proactively identify and mitigate compliance risk through data-driven monitoring
- Foster a culture of accountability, transparency, and quality ownership across the organization
- Provide quality oversight and coordination for internal and third-party audits
- Prepare the organization for inspection readiness for U.S.-based and global clinical programs through established quality systems, governance, and cross-functional alignment.
QUALIFICATIONS
- Bachelor's degree in a scientific or technical field, such as biology, chemistry, engineering, or related health science, with 6+ years of progressive Quality experience within a GxP-regulated industry
- Experience supporting inspection readiness, audits, or regulatory interactions through quality systems and cross-functional collaboration
- Experience managing, implementing or improving a Quality Management System
- Experience with implementing and maintaining electronic quality management systems (eQMS) such as Veeva, ZenQMS, MasterControl, etc.
- 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 quality systems
- Strong understanding of risk-based quality systems and continuous improvement concepts
- Experience partnering and leading cross-functional teams, including Regulatory, CMC, Clinical Operations, Information Technology and R&D
- Strong technical writing, organizational, and problem-solving skills.
- Demonstrated ability to translate regulatory and quality requirements into practical, scalable processes
PAY AND BENEFITS
We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life insurance, 401K matching, and uncapped vacation to our team. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play.
