Lead the QA investigations to ensure compliance and effective resolution of quality events in a regulated environment while managing workflows and metrics.
QA Investigations Lead with strong expertise in process investigations, capable of managing cross-functional teams, driving data-driven decision making, and establishing performance metrics (KPIs) to enhance investigation efficiency, compliance, and continuous improvement within GMP-regulated environments.
The selected candidate will be responsible for managing investigation workflows, tracking key metrics, leading cross-functional meetings, and challenging teams to ensure thorough root cause analysis and sustainable corrective actions.
Key Responsibilities
- Lead and manage the Quality Investigation System.
- Supervise and develop Data Reviewers team.
- Conduct daily triage meetings and weekly investigation status reviews.
- Ensure timely assignment, execution, and closure of investigations.
- Prepare and present monthly quality metrics to site.
Requirements
- Bachelor’s Degree in Sciences
- 10+ years of QA experience in the pharmaceutical industry.
- Strong knowledge of cGMP and quality systems.
- Proficiency in TrackWise, SAP, MS Office.
- Excellent communication skills in English and Spanish (speak, understand and write).
Similar Jobs
Artificial Intelligence • Big Data • Healthtech • Information Technology • Machine Learning • Software • Analytics
Review and resolve denied claims and insurance follow-up using payer portals and internal systems. Verify eligibility, contact payors, prioritize aged accounts, enter data, collaborate with teams, meet performance goals, and complete required training. Full-time with set AST hours; bilingual English/Spanish required.
Top Skills:
ExcelMicrosoft OutlookMicrosoft WordPayer PortalsWindows
Professional Services • Biotech • Consulting • Pharmaceutical
The Senior Project Manager will lead diverse projects, manage production lines, ensure compliance, develop project plans, and communicate with stakeholders.
Top Skills:
Project Management Tools
Professional Services • Biotech • Consulting • Pharmaceutical
The Industrial Engineer will lead lean manufacturing initiatives, optimize processes, calculate financial savings, and apply Six Sigma methodologies in a regulated environment.
Top Skills:
Lean Six Sigma ToolsMS OfficeStatistical Software
What you need to know about the San Francisco Tech Scene
San Francisco and the surrounding Bay Area attracts more startup funding than any other region in the world. Home to Stanford University and UC Berkeley, leading VC firms and several of the world’s most valuable companies, the Bay Area is the place to go for anyone looking to make it big in the tech industry. That said, San Francisco has a lot to offer beyond technology thanks to a thriving art and music scene, excellent food and a short drive to several of the country’s most beautiful recreational areas.
Key Facts About San Francisco Tech
- Number of Tech Workers: 365,500; 13.9% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Google, Apple, Salesforce, Meta
- Key Industries: Artificial intelligence, cloud computing, fintech, consumer technology, software
- Funding Landscape: $50.5 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Sequoia Capital, Andreessen Horowitz, Bessemer Venture Partners, Greylock Partners, Khosla Ventures, Kleiner Perkins
- Research Centers and Universities: Stanford University; University of California, Berkeley; University of San Francisco; Santa Clara University; Ames Research Center; Center for AI Safety; California Institute for Regenerative Medicine
