Corcept Therapeutics · 1 day ago
Manager, Quality Assurance Compliance
Redwood City, California, United States
Full-time
Hybrid
Mid, Senior Level
$140K/yr - $190K/yr
6+ years expCorcept Therapeutics is leading the way in the research and development of cortisol modulators. The Manager, Quality Assurance Compliance role ensures compliance with GxP guidelines across all supplier and vendor management relationships, responsible for supplier quality activities, managing audits, and driving continuous improvement initiatives.
BiotechnologyMedicalPharmaceutical
No H1B
Responsibilities
Support the qualification, monitoring and requalification process, including risk assessments of suppliers
May participate in GxP vendor qualification through risk-based audits and performance criteria
Support improvement initiatives to enhance supplier selection and compliance
Maintain and tracks key compliance metrics during management reviews to help ensure internal and external adherence to quality compliance and/or improvement opportunities
Manage the audit lifecycle such as scheduling, planning, issuing agendas, issuing reports, evaluating responses, requesting clarification, issuing Corrective Action (CA), Preventive Action (PA) and closing audits in Veeva
Develops external audit schedule for QA Ops
Ensure all suppliers comply with Corcept’s expectation, internal procedures and regulatory requirements. (FDA, EMA, and other international health authorities)
Authors Supplier Quality Agreements and work with internal and external stakeholders in the review and approval of quality agreements
Authors SOP in support of continual improvement initiatives
Qualification
Required
Support the qualification, monitoring and requalification process, including risk assessments of suppliers
May participate in GxP vendor qualification through risk-based audits and performance criteria
Support improvement initiatives to enhance supplier selection and compliance
Maintain and tracks key compliance metrics during management reviews to help ensure internal and external adherence to quality compliance and/or improvement opportunities
Manage the audit lifecycle such as scheduling, planning, issuing agendas, issuing reports, evaluating responses, requesting clarification, issuing Corrective Action (CA), Preventive Action (PA) and closing audits in Veeva
Develops external audit schedule for QA Ops
Ensure all suppliers comply with Corcept's expectation, internal procedures and regulatory requirements. (FDA, EMA, and other international health authorities)
Authors Supplier Quality Agreements and work with internal and external stakeholders in the review and approval of quality agreements
Authors SOP in support of continual improvement initiatives
Ability to work independently and communicate effectively and concisely (both verbal and written) with project team members and management groups and CSPs
Work well in a project team environment with problem analysis and decision-making ability
Ability to support internal and external compliance audits of suppliers, CLOs, and CMOs
Ability to identify compliance risk and recommend mitigations
Ability to author, review, and approve SOPs and other controlled documentation for compliance with applicable regulations
Strong statistical mindset and pragmatic decision making
Proficient computer skills are needed with experience using Microsoft Word, Excel, PowerPoint, and Visio
Travel may be required
Thorough knowledge of 21 CFR 210/211 global cGMP regulations, and ICH guidelines regarding good manufacturing practices in the development, manufacturing, testing, delivery, and control of pharmaceutical products
6+ years' experience in bio/pharmaceutical industry including 3+ years in Quality Assurance
Preferred
Knowledge of pharmaceutical manufacturing technologies and processes
Strong Veeva QMS experience is preferred
Bachelor's or master's degree in chemistry, biology, engineering or related field
Company
Corcept Therapeutics
Corcept Therapeutics discovers and develops drugs that regulate the effects of cortisol.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$119.09MKey Investors
Paperboy Ventures
2012-07-02IPO
2012-04-10Post Ipo Equity· $0.53M
2011-01-21Post Ipo Equity· $39M
Leadership Team
Roberto Vieira
President, Oncology
Yuan Xu
Associate Director, Statistical Programming
Recent News
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