Chief Quality and Compliance Officer for Pharmaceutical Programs

6 days ago


Mississauga, Ontario, Canada Roche Full time

About Roche

We are a leading research-focused healthcare group with over 100,000 people across 100 countries. Our headquarters is in Basel, Switzerland, where we have one of our largest sites with over 10,700 employees from around the world.

At Roche, we foster diversity, equity, and inclusion, representing the communities we serve. We believe that diverse perspectives are essential to understanding people's varied healthcare needs.

About the Role

We are seeking a Chief Quality and Compliance Officer for Pharmaceutical Programs to join our Digital Quality and Compliance Chapter in Roche Pharma Technical Operations. This role will be pivotal in shaping, implementing, and maintaining the Quality & Compliance Framework for complex programs.

You will report directly to the Chapter Lead of Digital Quality and Compliance and serve the ASPIRE Program in a matrix structure.

Key Responsibilities

  • Develop and Implement Quality Management Processes: Establish quality management processes for change management, discrepancy investigation/CAPA management, risk management, and documentation.
  • Ensure Compliance: Set up and maintain the Quality & Compliance Framework according to applicable requirements and standards and ensure adherence to GxP and other industry-related compliance obligations in design and deployment.
  • Provide Strategic Leadership: Align quality roles across program levels and business areas, providing critical input and oversight.
  • Oversee Documentation: Oversee key program documentation, including policies and procedures.
  • Support Deployment Reviews: Provide consultation and support for local ASPIRE QA/Compliance leads during all Deployment Gate Reviews.

Requirements and Qualifications

  1. Proven Experience: Proven experience in quality and compliance roles within the pharmaceutical industry with a strong understanding of GxP, CSV, ICH, and related quality standards.
  2. Degree and Expertise: Degree in Science, Engineering, and/or Business, along with proven expertise in the SAFe Framework and Quality Risk Management.
  3. Business Acumen: Strategic agility and business acumen, including finance, strategic planning, process management, and organizational development.

What We Offer

We offer competitive salary: $140,000 - $170,000 per year, flexible working options, 18 weeks of maternity leave and 10 weeks of gender-independent partnership leave. You will also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.



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