Global GMP Compliance Expert

F. Hoffmann-La Roche AG; Mississauga; On-site; CAD 106,000 - 139,000; Full time

Job summary

Hoffmann-La Roche Ltd. in Canada seeks an experienced GMP/GSDP auditor to lead audits across sites, affiliates, and suppliers. You will identify risks, develop mitigation plans, and support inspection readiness while promoting continuous improvement and cross-functional coaching.

The role requires 7+ years in regulated environments with 5+ years in GMP auditing or regulatory inspection management, a life sciences degree, and travel flexibility. Global regulatory knowledge is essential.

Qualifications

• 7+ years in a regulated environment (pharma/biopharma/medical device) with 5+ years in GMP auditing or regulatory inspection management.
• Bachelor’s degree (BA/BSc) in life sciences, pharmacy, or related discipline.
• Deep understanding of global quality and compliance regulations including cGMP and GSDP.
• Willingness to travel domestically and internationally.
• Preferred: experience across diverse manufacturing platforms and product lifecycle management.

Responsibilities

• Lead GMP and GSDP audits across internal sites, affiliates, suppliers, and service providers.
• Identify global inspection risks and develop strategic mitigation plans.
• Manage end-to-end inspection readiness programs and site inspections.
• Analyze regulatory trends and proactively mitigate compliance risks.
• Drive continual improvement of the operating model and mentor colleagues.

Skills

GMP auditing

Regulatory inspection management

Coaching cross-functional teams

Global quality regulations

Travel readiness

Education

Bachelor's degree in life sciences/pharmacy

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 Position 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** The expected salary range for this position based on the primary location of Mississauga is 105,560.00 and 138,547.50 of hiring range. Actual pay will be determined based on experience, qualifications, and other job-related factors as determined by the company. We use artificial intelligence to screen, assess or select applicants for this role. This posting is for an existing vacancy at Hoffmann-La Roche Ltd.

Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.