Verified Job
Manufacturing - Operations
External Quality System Manager
Manufacturing - Operations
#9189
Remote / WFH
Roche
Job Description
.
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.
The External Quality Systems Manager supports the implementation, maintenance, and continuous improvement of compliant Quality Management Systems (QMS) across the end-to-end External Quality organization. Ensures alignment with Roche standards and global regulatory requirements while enabling effective oversight of external partners across development, clinical, and commercial phases. Partners with cross-functional stakeholders to monitor system performance, identify risks and improvement opportunities, and drive fit-for-purpose, patient-centric solutions that enhance quality, compliance, and operational efficiency.
Mission of External Quality:
Roche partners with external organizations to ensure patients have access to quality products while maintaining flexibility and cost-efficiency. Through cross-functional collaboration and a focus on quality and compliance, these partnerships enable reliable delivery of products to patients worldwide.
Main Purpose of the Position:
This role focuses on implementing, maintaining, and continuously improving compliant Quality Management Systems (QMS) across the end-to-end External Quality organization. It ensures alignment with Roche standards and global regulatory requirements while supporting effective oversight of external partners across development, clinical, and commercial phases, and driving fit-for-purpose, patient-centric processes that enhance quality, compliance, and operational efficiency.
The Opportunity:
• Act as a Business Process Manager (BPM) for key Quality Systems across the end-to-end External Quality organization, ensuring processes are compliant, effective, and aligned with global regulatory requirements and Roche standards
• Oversee system performance through metrics, trend analysis, and root cause investigations, while supporting audits and health authority inspections.
• Working across development, clinical, and commercial phases, you will partner with internal and external stakeholders to align on quality expectations, provide subject matter expertise, and proactively manage quality and compliance risks.
• Drive continuous improvement and innovation across Quality Systems. You will lead or contribute to system enhancements, process upgrades, and digital initiatives, applying Lean and structured problem-solving methodologies to improve efficiency and reduce complexity.
• Acting as a change agent, you will help embed a culture of operational excellence, develop training and tools, and support capability building across the organization, all while managing competing priorities and contributing to broader organizational objectives.
Who You are:
• You bring a degree in Life Sciences (e.g. Chemistry, Chemical Engineering, Engineering, Pharmacy, Biochemistry ) with at least five years of experience in the pharmaceutical, biopharmaceutical, or related industry, along with strong knowledge of cGMP and global quality system regulations.
• You are skilled at working in a matrix environment, influencing stakeholders, and communicating complex topics clearly, with experience in supplier management or supply chain considered a plus.
• You demonstrate strong problem-solving and decision-making abilities with a risk-based, patient-centric mindset, and are comfortable navigating complexity and ambiguity.
• You take ownership, act with integrity, and apply continuous improvement and operational excellence tools (e.g., Lean) to drive outcomes, while maintaining proficiency in standard business tools and a commitment to ongoing learning.
Relocation benefits are not available for this job posting.
The expected salary range for this position based on the primary location of Mississauga is 105,560.00 and 138,547.50 of hiring range. Actual pay will be determined based on experience, qualifications, and other job-related factors as determined by the company.
ure, together.
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.
The External Quality Systems Manager supports the implementation, maintenance, and continuous improvement of compliant Quality Management Systems (QMS) across the end-to-end External Quality organization. Ensures alignment with Roche standards and global regulatory requirements while enabling effective oversight of external partners across development, clinical, and commercial phases. Partners with cross-functional stakeholders to monitor system performance, identify risks and improvement opportunities, and drive fit-for-purpose, patient-centric solutions that enhance quality, compliance, and operational efficiency.
Mission of External Quality:
Roche partners with external organizations to ensure patients have access to quality products while maintaining flexibility and cost-efficiency. Through cross-functional collaboration and a focus on quality and compliance, these partnerships enable reliable delivery of products to patients worldwide.
Main Purpose of the Position:
This role focuses on implementing, maintaining, and continuously improving compliant Quality Management Systems (QMS) across the end-to-end External Quality organization. It ensures alignment with Roche standards and global regulatory requirements while supporting effective oversight of external partners across development, clinical, and commercial phases, and driving fit-for-purpose, patient-centric processes that enhance quality, compliance, and operational efficiency.
The Opportunity:
• Act as a Business Process Manager (BPM) for key Quality Systems across the end-to-end External Quality organization, ensuring processes are compliant, effective, and aligned with global regulatory requirements and Roche standards
• Oversee system performance through metrics, trend analysis, and root cause investigations, while supporting audits and health authority inspections.
• Working across development, clinical, and commercial phases, you will partner with internal and external stakeholders to align on quality expectations, provide subject matter expertise, and proactively manage quality and compliance risks.
• Drive continuous improvement and innovation across Quality Systems. You will lead or contribute to system enhancements, process upgrades, and digital initiatives, applying Lean and structured problem-solving methodologies to improve efficiency and reduce complexity.
• Acting as a change agent, you will help embed a culture of operational excellence, develop training and tools, and support capability building across the organization, all while managing competing priorities and contributing to broader organizational objectives.
Who You are:
• You bring a degree in Life Sciences (e.g. Chemistry, Chemical Engineering, Engineering, Pharmacy, Biochemistry ) with at least five years of experience in the pharmaceutical, biopharmaceutical, or related industry, along with strong knowledge of cGMP and global quality system regulations.
• You are skilled at working in a matrix environment, influencing stakeholders, and communicating complex topics clearly, with experience in supplier management or supply chain considered a plus.
• You demonstrate strong problem-solving and decision-making abilities with a risk-based, patient-centric mindset, and are comfortable navigating complexity and ambiguity.
• You take ownership, act with integrity, and apply continuous improvement and operational excellence tools (e.g., Lean) to drive outcomes, while maintaining proficiency in standard business tools and a commitment to ongoing learning.
Relocation benefits are not available for this job posting.
The expected salary range for this position based on the primary location of Mississauga is 105,560.00 and 138,547.50 of hiring range. Actual pay will be determined based on experience, qualifications, and other job-related factors as determined by the company.
ure, together.
