202609-123465 Global GMP Compliance Expert

Roche; Mississauga; On-site; CAD 110,000 - 160,000; Full time

Job summary

Roche is seeking a senior professional to drive GMP and GSDP audits across internal sites, affiliates, suppliers and service providers, ensuring regulatory readiness. You will lead cross-functional teams to identify risks, develop mitigation plans, and mentor colleagues to uphold quality standards across the network.

You hold 7+ years in regulated environments with 5+ years in GMP auditing or inspection management, plus a life sciences degree. Domestic and international travel may be required.

Qualifications

• 7+ years in a regulated environment (pharma/biopharma/medical device).
• Minimum 5 years dedicated to GMP auditing or regulatory inspection management.
• Bachelor’s degree or equivalent in life sciences, pharmacy, or related field.

Responsibilities

• Drive GMP and GSDP audits across sites, affiliates, suppliers and providers.
• Identify global inspection risks and develop strategic mitigation plans.
• Lead end-to-end inspection readiness programs and support site inspections.
• Analyze global regulatory trends to mitigate compliance risks.
• Champion continuous improvement and streamline decision-making processes.
• Coach and mentor colleagues to foster learning and accountability.

Skills

GMP auditing

Regulatory inspection

Quality systems

Cross-functional coaching

Education

Bachelor's degree in life sciences or related field

Job description

At Roche, you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Opportunity

• Drive global compliance excellence by planning, executing, and reporting on Good Manufacturing Practice (GMP) and Good Storage & Distribution Practice (GSDP) audits across internal sites, affiliates, suppliers, and service providers.
• Partner cross-functionally to identify global inspection and audit risks, developing strategic mitigation plans to safeguard our operational integrity.
• Lead end-to-end inspection readiness programs and support site inspection management to ensure continuous regulatory readiness across the network.
• Analyze and communicate emerging global regulatory trends and intelligence to proactively mitigate compliance risks and strengthen site-level practices.
• Champion a continuous improvement mindset by contributing to the evolution of our operating model, identifying efficiencies, and streamlining decision-making processes.
• Coach and mentor colleagues across the organization, fostering a culture of continuous learning, open feedback, and shared accountability.

Who You Are

• You bring 7+ years of professional experience in a regulated environment (such as pharmaceutical, biopharmaceutical, or medical device industries), with at least 5 years dedicated to GMP auditing or regulatory inspection management.
• You hold a Bachelor’s degree (BA/BSc) or equivalent in life sciences, pharmacy, or a related scientific discipline.
• You possess a deep understanding of global quality and compliance regulations, including cGMP and GSDP requirements.
• You demonstrate proven capability in coaching, influencing, and guiding cross-functional teams without direct authority.
• You are comfortable with domestic and international business travel as required by operational needs.

Preferred:

• Experience across diverse manufacturing technology platforms and product life-cycle management.

** Relocation benefits not eligible for this positions**