Genentech

Genentech

International Quality Lead

South San Francisco, USA

Sponsorship not specified$111k-$206kDetected 1 day ago
GCPProject ManagementFDA RegulatoryPharmacovigilanceMedical DevicesProblem SolvingCritical ThinkingPublic SpeakingGxP

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odds of building a lasting career here

59Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role100
Entry-level history0
PERM / green-card track0
Lottery odds (Level III)83
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~45% per draw at Level III). Good if you win; have a cap-exempt backup on your list.

Lottery odds assume a STEM candidate.

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Employer immigration record

from this employer's Department of Labor filings

Green-card filing pattern in this occupation

Context, not a finding about this posting: of this employer's 21 green-card filings in this occupation, 100% were for a worker who already held the job.

Green-card follow-through: 77%

Of 13 labor certifications old enough to have been used, 3 expired without the employer filing the next step. Median time from filing to decision: 487 days.100% of their filings were for a worker who already held the job.Only certifications past the 180-day window are counted — recent ones cannot have expired yet.

Files H-1B transfers

34 transfer filings in the last year, covering 34 workers. Median labor-condition decision: 8 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

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About the role

  • Are you ready to shape the future of quality management in healthcare?
  • In this dynamic role, you will apply a risk-based approach to Quality Assurance using our Critical to Quality (CtQ) framework.

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.
  • Data & Digital Literacy: Excellent digital capabilities, with a good understanding of audit management and analytical reporting tools to drive data-led solutions.
  • It's what drives us to innovate.
  • 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.

Requirements

  • 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.
  • Critical Thinking: Proven problem-solving, decision-making, and project management skills with the ability to navigate ambiguous information.

Compensation

  • The expected salary range for this position based on the primary location of South San Francisco, CA is $111,000 - $206,100.

Benefits

  • To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.
  • 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.
  • 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.

Equal opportunity

  • equal opportunity employer.
  • If you have a disability and need an accommodation in relation to the online
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This listing is sourced directly from Genentech's careers page and normalized into a canonical job model.