Closed listing
Global GMP Compliance Expert
- Mississauga, ON, Canada
Full-time
This opening has closed.
The original listing is kept below for reference.
Job details
- Job type
- Full-time
- Closing date
- Posting language
- English
- Posted
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Search current openingsOriginal job description
Archived listing. The details below describe a past opening.
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
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.
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
- 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
- Experience across diverse manufacturing technology platforms and product life-cycle management.
- Relocation benefits not eligible for this positions**
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.
More about this job
Responsibilities
Plan, conduct, and report GMP and GSDP audits across internal sites, affiliates, suppliers, and service providers, while leading inspection readiness and supporting site inspection management. Identify and mitigate compliance risks, communicate regulatory trends, improve operating processes, and coach colleagues across the organization.
Requirements
Requires at least seven years of experience in a regulated industry, including five years in GMP auditing or regulatory inspection management, and a bachelor’s degree or equivalent in life sciences, pharmacy, or a related scientific discipline. Candidates need strong knowledge of global cGMP and GSDP requirements, cross-functional coaching and influencing skills, and willingness to travel domestically and internationally; experience with diverse manufacturing technologies and product life-cycle management is preferred.
Skills
- GMP Auditing
- GSDP Compliance
- Regulatory Inspection Management
- Inspection Readiness
- Audit Planning and Execution
- Regulatory Intelligence
- Risk Assessment and Mitigation
- Quality Compliance
- Cross-Functional Collaboration
- Coaching and Mentoring
- Continuous Improvement
- Manufacturing Technology
- Product Life-Cycle Management
Visa sponsorship
Not detected in the job text
Categories
- Healthcare
- Manufacturing
- Management & Leadership
Keywords
- Good Manufacturing Practice
- GMP
- Good Storage and Distribution Practice
- GSDP
- Current Good Manufacturing Practice
- cGMP
- Quality Assurance
- Compliance Audits
- Regulatory Inspections
- Inspection Readiness
- Audit Risk
- Risk Mitigation
- Regulatory Intelligence
- Pharmaceutical Manufacturing
- Biopharmaceuticals
- Medical Devices
- Life Sciences
- Pharmacy
- Manufacturing Technology Platforms
- Product Life-Cycle Management
- Continuous Improvement
- Cross-Functional Collaboration
- Coaching
- Mentoring