Regulatory Innovation & Sustainment Professional - Quality & Compliance

The Opportunity

As a Regulatory Innovation & Sustainment Professional within Pharma Development Regulatory's Quality & Compliance capability, you will be accountable for creating and maintaining the Quality Management System framework. You will foster innovation, identify continuous improvement opportunities, and develop risk-based quality strategies.

Responsibilities

• Act as a trusted partner to senior business stakeholders to ensure global quality standards are met.
• Collaborate with global teams to mature and sustain 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 GCP/GVP and Medical Device requirements.
• Optimize processes to enable operational excellence.

Requirements

• Bachelor’s degree in a scientific or quality-related field (advanced degree preferred).
• Minimum of 7 years of experience in Quality & Compliance, Regulatory Affairs, or Drug/Device Development.
• Strong understanding of regulated environments, industry frameworks, and digital systems.
• Strategic thinker with the ability to analyze complex data and translate insights into actionable reporting.
• Exceptional verbal and written communication skills for collaborating across global matrixed teams.
• Continuous improvement mindset with a proactive approach to process optimization.
• Ability to influence best practice adoption.
• Experience with audits or inspections is considered an asset.