Regulatory Innovation & Sustainment Professional - Quality & Compliance

Roche•Mississauga, ON

3d•CA$136,936 - CA$179,729

About The Position

As a Regulatory Innovation & Sustainment Professional within Pharma Development Regulatory's (PDR) Quality & Compliance capability, you will be accountable for creating and maintaining PDR’s Quality Management System (QMS) framework. This includes fostering innovation, identifying and implementing continuous improvement opportunities and developing risk-based quality strategies.

Requirements

Bachelor’s degree or equivalent in a scientific or quality-related field (an advanced degree is preferred).
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.
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.
Skilled at analyzing complex quality data and translating these insights into clear, actionable executive reporting and strategic messages.
Exceptional verbal and written communication skills with proven ability to communicate and collaborate effectively across global/local matrixed teams and senior leadership.
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.
Ability to influence best practice adoption.

Nice To Haves

Experience with audits or inspections is a plus, but not essential.

Responsibilities

Act 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 PDR’s 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.