Genentech

Genentech

Senior Clinical Quality Compliance and Policy Leader

South San Francisco · Senior

Sponsorship not specified$141k-$262kDetected 7 days ago
GCPStakeholder ManagementExcelClinical TrialsClinical ResearchFDA RegulatoryResearchCommunicationCollaborationProblem SolvingGxP

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odds of building a lasting career here

64Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role100
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). 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 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

  • Embed quality principles throughout the organization by delivering impactful compliance communications and targeted training to multidisciplinary teams.
  • Guide clinical study teams through root cause analysis, deviation management, and Corrective Action/Preventative Action (CAPA) plan development.

Responsibilities

  • In this role, you will embed quality by design across cutting-edge Early Development clinical programs, resolving complex compliance challenges before they impact study timelines or regulatory integrity.
  • Develop strategic partnerships with cross-functional teams in Early Clinical Development (ECD) and external vendor partners to advance compliance solutions and enable transparent issue resolution.
  • Provide expert GCP quality guidance, direction, and proactive risk-mitigation strategies to support early clinical trial conduct.
  • Support and participate in intradepartmental, global, and cross-functional initiatives, working groups, and project teams as a key decision-maker or lead reviewer.
  • Support or lead Quality Management System (QMS) activities, including controlled document management, strategic reviews and process alignment.
  • Collaborate on quality compliance checks and desktop assessments to evaluate clinical trial oversight and data integrity.
  • Background in supporting Quality Management System (QMS) processes and procedural documents.

Requirements

  • You possess 5-8 years of experience in pharmaceutical drug development (or 4-6 years with a Master's
  • 3-5 years with a PhD, JD, or MD), with a minimum of 6 years dedicated to a GCP-related discipline or Quality Assurance role.
  • You bring proven analytical and problem-solving skills, with a track record of identifying compliance risks, facilitating root cause analyses, and architecting practical CAPA solutions.
  • You excel at cross-functional collaboration and stakeholder management, with the ability to translate regulatory requirements into clear, actionable guidance while managing priorities independently.
  • Direct experience supporting Early Clinical Development (ECD) or first-in-human (Phase I/Ib) clinical trials.
  • Demonstrated experience with external vendor/CRO quality oversight, audits, and desktop assessments.

Compensation

  • The expected salary range for this position based on the primary location of CA is $141,100 - $262,100 Annual.

Benefits

  • You bring a Bachelor's degree in a life science, healthcare, or related discipline (advanced degree such as MS, PhD, JD, or MD welcomed).
  • Hands-on experience with Health Authority inspection preparedness, sponsor/site inspection hosting, and response strategy development (e.g., FDA, EMA).
  • No relocation benefits are available for this posting

Equal opportunity

  • equal opportunity employer.
  • If you have a disability and need an accommodation in relation to the online

Visa & Work Authorization

  • Hands-on experience with Health Authority inspection preparedness, sponsor/site inspection hosting, and response strategy development (e
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This listing is sourced directly from Genentech's careers page and normalized into a canonical job model.