Regulatory Innovation & Sustainment Professional - Quality & Compliance
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. 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.
Requirements
- Bachelor’s degree or equivalent in a scientific or quality-related field.
- 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.
- Advanced degree in a scientific or quality-related field.
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.
Benefits
- A discretionary annual bonus may be available based on individual and Company performance.
- Benefits detailed at the link provided below.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
