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Sr. Director of Quality Assurance
| Company | Celgard |
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| Location | Fremont, CA, USA |
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| Salary | $180000 – $200000 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Expert or higher |
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Requirements
- Bachelor’s degree in Engineering, Life Sciences, or related discipline with 15+ years of relevant experience, or combination of experience and relevant advanced degree
- In-depth understanding of technical documentation and knowledge of regulations: 21 CFR, ANNEX 1, ICH Q, etc.
- Experience leading and participating in regulatory inspections, client audits, etc.
- Flexible mindset for a dynamic environment
- Strong project management capabilities
- Ability to independently evaluate technical situations and propose potential solutions
- Ability to communicate clearly and professionally in writing and verbally
- Flexibility with work hours to meet business needs
- Strong analytical and problem-solving skills
Responsibilities
- Lead the Quality Assurance organization to generate a strong quality culture of engaged and motivated staff maintaining strong working relationships with clients, internal and external customers: Quality Control, Manufacturing, Engineering, supply chain and Process Development
- Implement and maintain a compliant QMS that is fit for purpose (clinical vs commercial) and follows and improves business performance and efficiency
- Participate as subject matter expert in deviation management investigations, CAPA and effectiveness check processes for continuous improvement and inspection readiness
- Establish and manage the Inspection Readiness program, Supplier Qualification program and overall Supplier lifecycle program
- Overall responsibility for the Batch Disposition program ensuring compliance with relevant regulations
- Manage relationship with clients’ QA organization
- Define and maintain a strong people management, training, and engagement culture to ensure a high and constantly improving right first time rate in manufacturing and QC
- Identify, recruit and manage the QA team, implementing a strong quality culture and ensuring staff engagement and development in line with the site competency framework
- Act as deputy for the SVP Quality and Compliance
- Perform other duties as assigned commensurate with job grade
Preferred Qualifications
No preferred qualifications provided.
