Sr. Director, Quality Systems - Temporary - Remote

Posted 8 weeks ago

Contract

USA

Quality Management System

Overview

The Sr. Director, Quality Systems is responsible for leading the Quality Systems team and collaborating with key stakeholders to provide services for GxP operations related to Quality Events such as Deviations, CAPA and Change Management; Training; Document Management & Archival; Supplier Quality and Internal & External Audit Programs across the organization.

In Short

Oversee the management and ongoing enhancement of the Quality Management System (QMS).
Build and expand Alector’s Quality System for a Phase 3 company.
Conduct ongoing analysis of Alector Policies and SOPs.
Collaborate with stakeholders to develop risk-based annual Audit plans.
Provide strategic direction for deviations, CAPAs, and change control processes.
Lead the development of Quality System metrics and continuous improvement programs.
Ensure GxP validated systems align with regulatory requirements.
Facilitate training and knowledge-sharing sessions.
Support regulatory inspections and foster a Quality culture.
Serve as a liaison with commercial partners for documentation requests.

Requirements

BS/BA, MS/MA, or PhD in a scientific discipline or related field.
15+ years’ experience in the Pharmaceutical/Biotechnology industry.
At least 5 years leading Quality System teams.
Expert knowledge of FDA, EMA, MHRA and ICH GxP regulations.
Proficient with Veeva Systems and ComplianceWire.
Extensive experience managing deviations, CAPAs, and change control.
Expertise in controlled documents for Phase 3 and commercial environments.
Experience with Risk Management program.
Strong communication skills with all organizational levels.
Excellent organizational, analytical, and problem-solving abilities.

Benefits

Opportunity to lead a critical function in a growing biotech company.
Engagement with experienced scientists and clinicians.
Contribute to the development of therapies for neurodegeneration.
Collaborate with leading healthcare investors and pharma partners.
Foster a culture of quality and compliance.

Alector

Alector is a pioneering biotechnology company dedicated to developing innovative therapies that harness the power of the immune system to combat neurodegenerative diseases. With a mission to transform the lives of patients facing some of the most challenging health issues, Alector is supported by a team of experienced scientists and clinicians, a robust portfolio of programs, and partnerships with leading healthcare investors and pharmaceutical companies. The company fosters a dynamic and inclusive work environment that encourages collaboration, creativity, and ownership, while prioritizing the well-being of its employees. Located in South San Francisco, Alector offers flexible work options and comprehensive benefits, reflecting its commitment to a diverse and supportive workplace.

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