Manager, Quality Assurance
Scorpion Therapeutics
Role
Quality Assurance (QA) Leader overseeing GMP and GLP compliance within biopharma manufacturing.
Objectives
Ensure product quality, regulatory adherence, and continuous process improvement.
Responsibilities
- Supervise QA staff
- Review controlled documents (SOPs, specifications)
- Manage compliance programs
- Analyze manufacturing and quality data
- Lead investigations and CAPAs
- Coordinate with R&D and contract manufacturers for new product launches and audits.
Requirements
- 7+ years in GMP environment
- BS/BA degree
- 5+ years with MS.
Preferred skills
- Deep knowledge of GMPs/GLPs
- QA principles
- Industry standards
- Statistical tools like Six Sigma and FMEA
- Strong project management
- Communication
- Technical writing skills.
High-value specifics
- Focus on manufacturing quality in biopharma
- Experience with quality systems regulations
- Compliance audits.
Work setup and travel details
Not specified.
#J-18808-LjbffrVacancy posted 2 days ago
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