Genentech

Associate Quality Lead (Quality Systems)

Genentech$89K — $117K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor’s degree in a scientific or quality-related discipline, or equivalent experience (1-3 years)
  • Experience in pharmaceutical, biotech, or medical device industries
  • Foundational understanding of product development and GxP regulations (e.g., GCP, GVP, MDR)
  • Strong digital and data literacy to interpret and translate data into insights
  • Exceptional organizational and execution skills with project ownership capability
  • Developing understanding of Critical to Quality (CtQ) factors and operations
  • Fluent in English with strong presentation skills

Responsibilities

  • Implement quality strategies for PDQ portfolio
  • Execute quality assurance activities to build confidence in systems
  • Enhance data collection processes and deliver insights
  • Present quality strategy implementations to health authorities
  • Participate in compliance projects for operational optimization
  • Drive adoption of digital tools for proactive quality culture
  • Support process mapping for documentation in the QMS
  • Provide logistical support for GxP inspections

Benefits

  • Opportunities for professional growth
  • Empowerment to work independently
  • Environment that values continuous learning
  • No relocation benefits
Full Job Description
The Position

Are you ready to shape the future of quality management in healthcare? As an Associate Quality Lead within our Pharma Development Quality (PDQ) function, you will play a vital role in supporting the delivery of quality-focused strategies that reinforce trust in our Quality Management System (QMS). Working with a high degree of independence, you will collaborate with cross-functional teams to ensure our clinical and safety data meets rigorous global regulatory standards.

In this dynamic position, you will have the unique opportunity to champion a culture of continuous improvement and innovation. By leveraging data analytics and digital tools, you will help optimize data collection and provide key insights that directly support our mission of delivering life-changing medicines to patients faster and more securely.

The Opportunity:

  • Implement Quality Strategies: Support the design, execution, and tracking of risk-based quality management strategies across the PDQ portfolio.

  • Deliver Quality Assurance: Execute targeted activities to assess quality assurance status and generate confidence in our end-to-end systems.

  • Manage Quality Data: Enhance data collection procedures, perform ad-hoc analyses, and deliver high-quality data insights to fulfil external regulatory needs.

  • Present to Health Authorities: Demonstrate the effective implementation of quality strategies.

  • Drive Compliance Projects: Participate in departmental or cross-functional compliance initiatives aimed at optimizing daily operations.

  • Champion Innovation: Drive the adoption of innovative digital tools and technologies into daily workflows to foster a proactive quality culture.

  • Foster Collaboration: Build and maintain an inclusive, supportive work environment while executing departmental goals and initiatives under limited supervision.

  • Process Mapping: Support process mapping activities to enable the documentation and visualization of simple workflows within the QMS.

  • Inspection Support: Provide logistical and compliance support for GxP inspections, including scribe duties and back-room document QC.

Who You Are:

You are a proactive, organized professional looking to elevate your career in quality management within a global, life-changing industry. You thrive in environments that value continuous learning, offer room for professional growth, and empower you to work independently to make a genuine impact on patient outcomes.

To be successful in this role, you bring:

  • A Bachelor’s degree in a scientific or quality-related discipline, or an equivalent combination of education and 1-3 years of experience .

  • Experience within the pharmaceutical, biotech, or medical device industry, with a foundational understanding of product development and GxP regulations (e.g., GCP, GVP, MDR).

  • Strong digital and data literacy, with the ability to interpret data and translate it into actionable quality insights.

  • Exceptional organizational and execution skills, alongside a demonstrated ability to take ownership of projects proactively.

  • Developing expertise in Critical to Quality (CtQ) factors and functional group operations.

  • Fluency in written and spoken English, with strong presentation skills.

Relocation Benefits are not available for this job posting.

#MQRS

The expected salary range for this position based on the primary location of Mississauga is 89,256.00 and 117,148.50 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.

About Genentech

Genentech is a biotechnology company that develops and manufactures drugs for the treatment of serious medical conditions. The company was founded in 1976 and is headquartered in South San Francisco, California. Genentech's products include treatments for cancer, multiple sclerosis, and other diseases. The company is a subsidiary of Roche, a Swiss pharmaceutical company. Genentech has been recognized for its innovative research and development, and has received numerous awards for its contributions to the biotechnology industry.
Learn more about Genentech
Size
14,000 employees
Industry
Founded
1976

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