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 PositionAt Roche, we believe every employee can make a real difference. We are a global leader in healthcare, combining our strengths in Pharmaceuticals and Diagnostics to improve lives and advance the frontiers of science. With a history of innovation spanning over 125 years, our mission is to deliver better outcomes for more patients, faster. We foster an environment of belonging, where diverse perspectives are celebrated and where our commitment to sustainability and ethics drives everything we do. Join us in our pursuit to transform the future of medicine.
The OpportunityAs the IMPQ Quality Systems and Quality Strategy Implementation Lead, you will play a pivotal role in shaping the quality landscape of our Investigational Medicinal Products (IMP) and Cell & Gene Therapy (CGT) networks.
You will provide strategic functional leadership for the successful deployment and integration of the PT Quality Management System (QMS) across the global IMP and CGT networks.
You will act as the Quality Process Owner (QPO) for specific QMS processes, ensuring that product development and clinical supply operations remain in a constant state of inspection readiness.
You will drive the execution of the IMP Quality Strategy, overseeing high-impact strategic initiatives including compliance improvement programs and organizational transformation.
You will harmonize and standardize quality processes and systems across PTD, PTC, and REDs to ensure a consistent application of global standards across all operational touchpoints.
You will proactively identify, communicate, and manage quality and compliance risks, representing IMP Quality in the PTQ Risk Roll-Up process to safeguard our license to operate.
You will collaborate as a member of the Global IMPQ Leadership Team and an extended PTQ Leadership member to align site and functional operations with overarching corporate objectives.
You will build and maintain strong partnerships with cross-functional stakeholders to facilitate expert interpretation of QMS requirements and support the management of routine and complex quality audits.
We are looking for a visionary leader with a deep technical foundation in quality systems and the ability to influence global healthcare standards.
You possess a Bachelor’s degree in Life Sciences, Pharmacy, or a related field, with a PhD considered a distinct advantage for this strategic level.
You bring at least 15 years of experience in the Pharmaceutical or Biopharmaceutical industry, with a minimum of ten years specifically focused on Quality, Compliance, Regulatory, or Validation.
You have demonstrated leadership excellence with at least eight years of experience in a management capacity, ideally within a complex matrix environment.
You are an expert in US, European, and International cGMP regulations, with the specialized ability to interpret and implement quality standards in early to late-stage technical development.
You possess a proven track record of managing Quality Systems and successfully leading organizations through US, European, and other relevant Health Authority inspections.
You are skilled at driving positive change and continuous improvement, utilizing your strong collaboration and influencing skills to solve complex problems across a global network.
You exhibit the professional maturity to notify Senior Management of critical regulatory issues and the accountability to deliver results that align with Roche’s core competencies.
**This role is not eligible for relocation**
The expected salary range for this position based on the primary location of Mississauga is 148,568.00 and 194,995.50 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 areA 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.
.png)
