First seen by our source: 6 hours ago
International Quality Lead
@ Genentech
Mississauga, Ontario
SIGNALS
Overview
Genentech is hiring an International Quality Lead within its Pharma Development Quality division to develop risk-based quality assurance strategies, lead global audits and support regulatory inspections. The role is full-time, based in South San Francisco, CA or Mississauga, with a salary range of $111,000 - $206,100 in South San Francisco plus a discretionary annual bonus.
Responsibilities:
- Plan, perform and lead global GCP and GVP audits
- Apply risk-based QA strategies using the CtQ framework
- Partner with business stakeholders on audit findings and risks
- Support regulatory authority inspection preparation
- Contribute to continuous improvement of PDQ processes
Requirements summary:
- Bachelor's degree or equivalent in a scientific or quality field
- Proven pharma, biotech or medical device industry experience
- Strong knowledge of global GxP regulations (GCP, GVP, IVD/MD)
- Excellent audit management and analytical reporting skills
- Proven problem-solving and project management skills
Tools & skills
Source and dates
Source type not verified · apify-linkedin
- Employer posting date
- Not provided
- First seen by our source
- 2026-11-14
- Source record updated
- 2026-11-14
These dates describe the source record, not a live verification that the employer is still hiring. Check the original posting.
Job details
| Seniority | Lead |
| Department | Quality assurance |
| Hours per week | 40 (estimated) |
| Travel | air: moderate · ground: minimal |
| Work setting | Office |
| Position | Mostly sitting |
| Physical demands | physical low · computer high |
| Languages | English |
| Education | Bachelor’s degree (required) |
| Fields of study | scientific field, quality-related field |
| Perks mentioned | Performance bonus |
Summary and details written by AI from the posting; the employer’s posting is the authority.
Genentech
| Field | Value |
|---|---|
| Open jobs on Jobsy | 2 |
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 Genentech / Roche!
The Opportunity
Are you ready to shape the future of quality management in healthcare? As a Quality Lead within our Pharma Development Quality (PDQ) division, you will support the Roche/Genentech organisation by developing and delivering robust Quality Assurance strategies, audits, and conclusions across molecules in development, post-approval products, and global processes. You will act as a trusted partner, ensuring our operations maintain the highest standards of compliance while directly influencing how we bring innovative therapies to patients safely and efficiently.
In this dynamic role, you will apply a risk-based approach to Quality Assurance using our Critical to Quality (CtQ) framework. By generating actionable data and insights through audits, you will collaborate closely with international stakeholders and play a vital part in preparing for and supporting regulatory authority inspections. This is an exceptional opportunity to utilise your expertise in a truly global, agile matrix environment where your insights drive continuous improvement.
Key Responsibilities:
You are a proactive, analytical quality professional who thrives on transforming complex data into clear, actionable solutions. You are an excellent communicator, highly skilled at collaborating across cultures and influencing stakeholders at various levels with or without formal authority. You look for opportunities to develop your skills within an international team and are passionate about continuous growth.
To be successful in this role, you bring:
Benefits
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
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 Genentech / Roche!
The Opportunity
Are you ready to shape the future of quality management in healthcare? As a Quality Lead within our Pharma Development Quality (PDQ) division, you will support the Roche/Genentech organisation by developing and delivering robust Quality Assurance strategies, audits, and conclusions across molecules in development, post-approval products, and global processes. You will act as a trusted partner, ensuring our operations maintain the highest standards of compliance while directly influencing how we bring innovative therapies to patients safely and efficiently.
In this dynamic role, you will apply a risk-based approach to Quality Assurance using our Critical to Quality (CtQ) framework. By generating actionable data and insights through audits, you will collaborate closely with international stakeholders and play a vital part in preparing for and supporting regulatory authority inspections. This is an exceptional opportunity to utilise your expertise in a truly global, agile matrix environment where your insights drive continuous improvement.
Key Responsibilities:
- Drive Quality Strategies: Support the execution of risk-based Quality Assurance strategies and conclusions in predominantly Good Pharmacovigilance Practice (GVP) as well Good Clinical Practice (GCP),using the Critical to Quality (CtQ) framework.
- Lead Global Audits: Plan, perform, and lead audits, grouping individual issues into systematic trends to provide valuable quality data that fulfils regulatory requirements.
- Partner with Stakeholders: Establish and maintain strong partnerships with business stakeholders, presenting audit observations and associated compliance risks clearly.
- Support Inspections: Play a key role in regulatory authority inspection preparation and management.
- Advance PDQ Processes: Participate actively in assigned departmental goals and initiatives, contributing directly to the continuous improvement of PDQ processes.
- Maintain GxP Expertise: Maintain deep awareness and expertise in global regulations (such as FDA, EU, and ICH guidance) across GCP, GVP, or Medical Device frameworks.
You are a proactive, analytical quality professional who thrives on transforming complex data into clear, actionable solutions. You are an excellent communicator, highly skilled at collaborating across cultures and influencing stakeholders at various levels with or without formal authority. You look for opportunities to develop your skills within an international team and are passionate about continuous growth.
To be successful in this role, you bring:
- Education: A Bachelor’s degree or equivalent in a scientific or quality-related field, or equivalent combined experience.
- Industry Experience: Proven experience within the pharmaceutical, biotech, or medical device industry, with solid knowledge of end-to-end product operationalisation.
- GxP Knowledge: Strong exposure to and understanding of global GxP regulations and quality roles, specifically within GCP, GVP, or IVD/MD frameworks.
- Data & Digital Literacy: Excellent digital capabilities, with a good understanding of audit management and analytical reporting tools to drive data-led solutions.
- Critical Thinking: Proven problem-solving, decision-making, and project management skills with the ability to navigate ambiguous information.
- This position is based at our South San Francisco, CA campus or Mississauga offices
- Relocation benefits are not available for this job posting.
Benefits
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
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