The Vice President, Quality leads the Quality department, embedding a quality attitude throughout the organization and executing on continuous improvement opportunities at Alector.
Essential responsibilities include:
- Developing a risk-based Quality strategy which aligns with Alector’s corporate risk management approach to ensure timely, effective, and consistent delivery of GxP compliance support across and within programs
- Directing, coordinating, creating, and evaluating the activities of the Quality department, including hiring, managing, and developing Quality employees and consultants
- Implementing process improvements to ensure GxP compliance in a Phase 3 clinical development environment with a strategic view to grow the Quality function as Alector’s products advance to potential commercialization
- Providing oversight to ensure the adequacy of Quality Management System (QMS) components including creation and revision of SOPs and training programs for GxP compliance, documentation of QMS-required training, management of GxP validated systems, and support for GxP Vendor management
- Leading regulatory inspection activities, including coordinating inspection readiness activities across internal functional areas and at investigator sites, hosting regulatory inspections, and managing the inspection response activities including ensuring timely completion of committed deliverables
- Leading regulatory preparedness for prior approval inspections, including management & coordination of CDMOs.
- Creating a phase-appropriate audit strategy for all programs, including audits of CDMOs, Vendors and investigational sites
- Advising on the development of corrective and preventive action plans following identification of compliance issues both internally and with investigational sites, Vendors and CDMOs
- Overseeing investigations into significant quality issues, suspected scientific misconduct and suspected serious breach of GXP, including ensuring conduct of compliant root cause analysis, development of corrective and preventive actions and reporting of potential or confirmed violations to regulatory authorities, as appropriate
- Maintaining awareness and informing senior leadership of potential issues impacting Alector’s business processes
- Representing Quality Assurance on cross-functional leadership teams and serving as a resource for quality and compliance questions, issues, and planning across the organization, including providing guidance based on current global regulations, industry standards, and best practices
- Serving on Joint Steering Committees for Alector with CDMOs, Vendors and commercial partners
- Developing and managing departmental budget, timelines, and resources
Skills & Experience
- BS/BA, MS/MA, or PhD in a scientific discipline or related field
- 15+ years’ experience as a lead in a Quality function with increasing levels of responsibility in the biotech/pharmaceutical industry, including 5+ years’ experience as a Quality Department Head
- Extensive, knowledge of current GxP principles, global regulatory requirements, international guidance documents, quality systems, inspections, and audits
- Demonstrated leadership and decision-making skills within a Quality organization, with proven ability to communicate effectively with employees, senior/executive leadership, Vendors, regulatory authorities, and business partners.
- Significant experience in planning for and hosting regulatory inspections.
- Excellent hands-on experience with implementing and managing phase appropriate Quality/Compliance systems and processes
- Extremely detail-oriented with strong organizational skills and high-quality standards
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Last updated on Apr 19, 2024