PTQ Risk Management Lead

Roche

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About this job

Full time
Mississauga, Ontario
July 21, 2025
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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

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.

That’s what makes us Roche.

     

We seek a globally experienced leader to serve as the Pharma Technical (PT) Quality Risk Management Lead, responsible for defining and embedding a best-in-class Quality Risk Management (QRM) framework across the PT network. This strategic role focuses on identifying, evaluating, and escalating critical risks within manufacturing, quality systems, supply chain, and regulatory functions to guide enterprise decision-making. Key responsibilities include leading the PTQ-to-PT risk roll-up process, integrating QRM into core business operations, and influencing cross-functional leaders to align on long-term operational resilience and regulatory readiness. As a strategic enabler, this position transforms quality risk into a competitive advantage, driving informed business prioritization, resource allocation, and enterprise planning.

               

The Opportunity:

  • You will own and lead the PTQ-to-PT risk roll-up process, translating risks into enterprise-aligned narratives for governance forums.
  • You will define and maintain the global QRM strategy, ensuring compliance with ICH Q9(R1), GMP and internal Quality Management System (QMS) requirements.
  • You will guide teams on QMS and QRM requirements, supporting inspection readiness and regulatory responses.
  • You will develop and manage dashboards, KPIs, and analytics to monitor emerging risks and mitigation effectiveness.
  • You will collaborate across Manufacturing, Supply Chain, Regulatory, and other teams to address systemic risks and standardize QRM practices.
  • You will drive automation and digital enablement of risk management tools, in collaboration with process owners and metrics teams using platforms like Tableau.
  • You will represent Roche as a QRM thought leader in industry forums and contribute to enterprise-wide strategic initiatives.

Who you are:

  • You hold an advanced degree in Life Sciences, Engineering, Pharmacy, or a related field; an MBA or Risk Management certification is a plus.
  • You bring 10+ years of experience in the pharmaceutical/biotech industry, including leadership roles in a combination of quality, risk management, operations and regulatory.
  • You demonstrate expertise in ICH Q9(R1), QMS, cGMP, and global regulatory standards, with a track record in quality process improvement.
  • You lead enterprise risk governance, cross-functional forums, and executive-level reporting with strategic clarity and innovation.
  • You excel in analyzing complex risk data and converting it into actionable insights using tools like Power BI, Tableau, and cloud platforms.
  • You are an effective communicator, skilled in stakeholder management and fostering inclusive, collaborative environments in matrixed organizations.
  • You are open to travel requirements, up to 15%.

Relocation benefits not eligible for this position

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.