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QC Manager
| Company | Neurocrine Biosciences |
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| Location | San Diego, CA, USA |
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| Salary | $113100 – $164100 |
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| Type | Full-Time |
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| Degrees | Bachelor’s, Master’s |
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| Experience Level | Senior |
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Requirements
- BS/BA degree in life sciences or related field and 6+ years of experience within Pharmaceutical/Biotechnology industry OR
- Master’s degree in life sciences or related field and 4+ years of similar experience noted above
- Leadership capabilities and experience applying CGMP requirements in a Quality Control setting
- Working knowledge of quality systems and regulatory compliance requirements within a clinical and commercial drug manufacturing operation
- Experience in analytical development and/or testing in a Quality Control setting
- Experience with using electronic documents management systems, laboratory data management systems, document control and records management
- Knowledge of US FDA and European regulations and ICH Guidelines
- Works well in a team environment with the ability to drive results
- Ability to independently meet multiple deadlines, with a high degree of accuracy and efficiency
- Capable of handling multiple responsibilities and prioritizing appropriately
- Strong scientific data management and organization skills with attention to detail
- Ability to identify and escalate problems and follow-through with corrective actions
- Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation while creating opportunities to improve operations and effective implementation to reduce errors
- Strong level of analysis skills to evaluate and interpret data to arrive at logical and quality-minded conclusions
- Apply problem-solving tools for root cause analysis
- Excellent computer skills
- Strong communication skills
Responsibilities
- Review and approve API and drug product analytical records for clinical and commercial products
- Review and approve stability data supporting retest period assignment for clinical and commercial products
- Review and approve internal and external test method validation protocols and reports
- Review and approve equipment/instrument qualification, calibration and maintenance records to support the internal GMP lab
- Participate in project teams, serving as the QC representative and escalate issues to senior Quality management when appropriate
- Interact with cross-functional team members, external manufacturing sites and contract testing labs to resolve analytical testing issues
- Lead or participate in deviation and laboratory investigation teams
- Facilitate the change control process for analytical changes related to clinical and commercial products
- Prepare reports for management review of key statistics such as vendor performance based on findings from analytical record reviews
- Author and review controlled documents, including Standard Operating Procedures, analytical methods, protocols and reports related to lab activities
- Author and review analytical modules in regulatory submissions
- Conduct and support audits of external vendors
- Assist during onsite inspections and inspection readiness activities
- May lead junior staff and/or cross-functional teams
- Perform additional duties as assigned by management
Preferred Qualifications
No preferred qualifications provided.
