As a Regulatory Innovation & Sustainment Professional within Pharma Development Regulatorys (PDR) Quality & Compliance capability, you will be accountable for creating and maintaining PDRs Quality Management System (QMS) framework. This includes fostering innovation, identifying and implementing continuous improvement opportunities and developing risk-based quality strategies.
The OpportunityAct as a trusted partner to senior business stakeholders, leading or supporting cross-functional collaboration to ensure global quality standards are met while navigating complex regulatory landscapes.
Collaborate with global teams to mature and sustain PDRs Quality & Compliance capabilities.
Monitor external trends and regulatory changes to ensure ongoing readiness.
Identify opportunities for continuous improvement and drive strategic change initiatives.
Lead internal/external audits, Health Authority inspections, and risk assessments.
Ensure compliance with global regulatory standards including Good Clinical Practice / Good Pharmacovigilance Practice (GCP/GVP) and Medical Device related requirements, where applicable.
Optimize processes to enable operational excellence and maintain our license to operate.
Who You AreYou have a Bachelors degree or equivalent in a scientific or quality-related field.
You have a minimum of 7 years of experience in Quality & Compliance, Regulatory Affairs or Drug and/or Device Development, with a strong understanding of regulated environments, industry frameworks, data and digital systems.
Youre a strategic thinker and problem solver who thrives in a fast-paced, collaborative environment, driven by purpose, excited by innovation, and confident in influencing change across a complex organization.
You are skilled at analyzing complex quality data and translating these insights into clear, actionable executive reporting and strategic messages.
You possess exceptional verbal and written communication skills with proven ability to communicate and collaborate effectively across global/local matrixed teams and senior leadership.
You possess a continuous improvement mindset and a proactive approach to solving challenges, with the ability to assess end-to-end processes, identify inconsistencies, and improve process effectiveness and efficiency.
You can influence best practice adoption.
Preferred:Experience with audits or inspections is a plus, but not essential.
Advanced degree in a scientific or quality-related field.
Relocation benefits are not available for this job posting.
The expected salary range for this position based on the primary location of South San Francisco, CA is $141,100 - $262,100. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits