Senior Manager, Quality Systems, Compliance

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in guiding activities related to Quality Systems and Compliance

• Develop and implement a Quality Management System that supports clinical development programs and the expanding pipeline

• Execute and facilitate the ongoing effectiveness of the QMS

• Oversee deviations and investigations, CAPA, change controls, risk assessments, quality events, and effectiveness evaluations

• Collaborate with external partners and suppliers/vendors on quality initiatives

• Create controlled documentation and governance frameworks for essential processes and continuous enhancement

• Aid in ensuring regulatory compliance in drug production operations

• Execute a quality roadmap that translates regulatory and quality requirements into scalable operating models

• Identify and mitigate compliance risks through data-driven monitoring

• Promote accountability, transparency, and quality ownership throughout the organization

• Provide quality oversight and coordination for both internal and third-party audits

• Prepare U.S.-based and global clinical programs for inspection readiness

• Collaborate with leadership from Regulatory, Medical, Clinical, R&D, and Technology

⛳️ Requirements

• Bachelor’s degree in a scientific or technical discipline, such as biology, chemistry, engineering, or a related health science

• 6+ years of advancing Quality experience within a GxP-regulated sector

• Experience in supporting inspection readiness, audits, or regulatory interactions through quality systems and cross-functional collaboration

• Proven experience in managing, implementing, or enhancing a Quality Management System

• Familiarity with the implementation and maintenance of electronic quality management systems (eQMS) like Veeva, ZenQMS, or MasterControl

• Knowledge of global regulatory expectations relevant to clinical development, including U.S. and international considerations

• Working knowledge of GCP and applicable GMP principles concerning quality systems

• Strong understanding of risk-based quality systems and concepts of continuous improvement

• Experience in partnering and leading cross-functional teams, including Regulatory, CMC, Clinical Operations, Information Technology, and R&D

• Excellent technical writing, organizational, and problem-solving abilities

• Demonstrated capability to translate regulatory and quality requirements into practical, scalable processes

• Must be currently authorized to work in the United States

• Must indicate whether visa sponsorship is required

• Must have experience managing a validated eQMS

🏝️ Benefits

• Company-paid healthcare

• Flexible spending accounts

• Voluntary life insurance

• 401K matching

• Uncapped vacation

• Onsite gym

• Dining options at the San Diego facility

• Flexible remote or hybrid work arrangements