Senior Quality Manager
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Job Description
Senior Quality Manager overseeing Quality department at Cristcot focusing on regulatory compliance and product quality. Collaborating with multiple teams and managing quality systems to ensure efficiency.
Responsibilities:
- Lead and manage the Quality department, including hiring, training, and performance management
- Ensure compliance with cGMP, FDA, EMA, ISO 13485 and other global regulatory requirements
- Oversee quality systems including CAPA, deviations, change control, and document management
- Function as the primary quality interface with CDMOs and testing labs.
- Drive inspection readiness and lead internal audits
- Review and approve batch records, SOPs, change controls, methods, specifications, protocols and reports, and quality-related documentation
- Collaborate with cross-functional teams to support product development and commercialization
- Manage supplier quality and oversee vendor qualification processes
- Identify and implement continuous improvement initiatives within the quality system
- Monitor key quality metrics and report trends to senior leadership
- Ensure proper investigation and resolution of quality issues and complaints
Requirements:
- Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field (advanced degree preferred)
- 8–12+ years of experience in pharmaceutical/biotech QA roles, with leadership responsibility
- Strong knowledge of cGMP regulations and global regulatory requirements
- Proven hands-on experience managing quality systems (batch review, CAPA, deviations, change control)
- Strong analytical and problem-solving abilities
- Ability to travel up to 10–20% as needed
Benefits:
- Health insurance
- Retirement plans
- Paid time off
- Professional development opportunities
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