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Manager – Quality Assurance – Product Complaint
| Company | BridgeBio |
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| Location | San Francisco, CA, USA |
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| Salary | $120000 – $160000 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Senior |
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Requirements
- Bachelor’s degree or equivalent in operations, science, mathematics, or engineering required
- A minimum of 5+ years of experience working in a Biotech or Pharmaceutical FDA regulated industry in QA or a related field or an equivalent combination of education, training, and/or experience from which comparable knowledge, skills, and abilities have been attained
- Extensive knowledge of US, European and Global product quality complaint handling requirements, and associated guidelines
- Experience with implementing and maintaining pharmaceutical quality management systems
- Excellent analytical and critical thinking skills, with keen attention to detail
- Proficiency in eQMS, Microsoft Office, Google Docs, etc.
- Experience with commercial marketed products
- Ready to embrace companies core values and diverse corporate culture
Responsibilities
- Maintain and continuously improve global processes related to complaint handling, mock recalls, recalls, and notifications
- Ensures timely complaint initiation, investigation/analysis, reportability assessments, and reporting to appropriate domestic and international governments as required, and complaint closures
- Perform monthly reconciliation, trend reports and metrics for Complaints to identify potential quality issues
- Coordinate with SMEs to ensure all product complaint investigations are completed with minimal guidance and ensure investigation action plans and final investigation summaries are accurate, including appropriate corrective actions, and follow the company’s standards
- Collaborate with departments (e.g. Affiliates, Manufacturing /Packaging sites, Vendors) to establish appropriate, efficient, and timely investigation strategies
- Collaborate with key stakeholders to foster effective interdepartmental and cross-functional partnership
- Escalate to management of potential quality or regulatory issues that may affect product quality or regulatory compliance
- Participate in audits and regulatory inspections
- Establish work priorities to meet targets and timelines and effectively manage competing priorities with minimal escalations
- Serve as the Quality representative in cross-functional and multi-site teams
- Other duties as assigned
Preferred Qualifications
No preferred qualifications provided.
