Global GMP Compliance Expert
Mississauga - Canada
Job Summary
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.
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 Bachelors 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 105560.00 and 138547.50 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.
A healthier future drives us to innovate. Together more than 100000 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.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
About Company
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.