International Quality Lead

Roche

. Support the execution of risk-based Quality Assurance strategies and conclusions, predominantly in Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP), using the Critical to Quality (CtQ) framework .

Posted 10/12/2026full-timeSouth San Francisco • California • United StatesSenior💰 $111,000 - $206,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Assurance strategies within the pharmaceutical and biotech industries, focusing on Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP). Proficient in audit management, regulatory compliance, and data analysis to support continuous improvement in Pharma Development Quality (PDQ) processes.

Highest-signal resume keywords

Quality Assurance StrategiesGlobal GxP RegulationsAudit ManagementRegulatory ComplianceProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Good Pharmacovigilance PracticeGood Clinical PracticeAudit ManagementAnalytical ReportingData AnalysisRegulatory RequirementsProduct OperationalisationContinuous ImprovementCritical to Quality FrameworkGlobal Processes

Soft Skills

Problem-SolvingDecision-MakingCommunicationCollaborationNavigating Ambiguity

Tools & Technologies

Audit Management ToolsAnalytical Reporting ToolsDigital Capabilities

Industry Keywords

Pharmaceutical IndustryBiotech IndustryMedical Device IndustryFDA RegulationsEU RegulationsICH GuidanceGxP Frameworks

About the role

Key responsibilities & impact

Support the execution of risk-based Quality Assurance strategies and conclusions, predominantly in Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP), using the Critical to Quality (CtQ) framework
Plan, perform, and lead global audits
Group individual audit issues into systematic trends and provide quality data fulfilling regulatory requirements
Establish and maintain partnerships with business stakeholders
Present audit observations and associated compliance risks clearly
Support regulatory authority inspection preparation and management
Participate in departmental goals and initiatives
Contribute to continuous improvement of Pharma Development Quality (PDQ) processes
Apply actionable data and insights through audits across molecules in development, post-approval products, and global processes

Requirements

What you’ll need

Bachelor’s degree or equivalent in a scientific or quality-related field, or equivalent combined experience
Proven experience within the pharmaceutical, biotech, or medical device industry
Solid knowledge of end-to-end product operationalisation
Strong exposure to and understanding of global GxP regulations and quality roles, specifically within GCP, GVP, or IVD/MD frameworks
Excellent digital capabilities
Good understanding of audit management and analytical reporting tools
Proven problem-solving, decision-making, and project management skills
Ability to navigate ambiguous information
Deep awareness and expertise in global regulations, such as FDA, EU, and ICH guidance, across GCP, GVP, or Medical Device frameworks
Excellent communication and collaboration skills across cultures and stakeholder levels

Benefits

Comp & perks

A discretionary annual bonus may be available based on individual and Company performance
Benefits detailed at the link provided below
Relocation benefits are not available for this job posting