Sr. Director, Quality Systems - Temporary

Our mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. By harnessing advancements in genetics, immunology and neuroscience, we are pioneering the development of potential therapies to counteract the devastating progression of neurodegeneration. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare investors, and pharma company partners, who share in our commitment to bettering the lives of patients and realizing a world where we make brain disorders history.

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. 

• Oversee the management and ongoing enhancement of the Quality Management System (QMS), ensuring its effectiveness and compliance across GxP areas
• Continue to build and expand Alector’s Quality System to ensure that it is optimally designed and implemented to address the demands of a Phase 3 company
• Conduct ongoing analysis of Alector Policies and SOPs and lead the implementation of strategic initiatives to create, modify, or obsolete processes as needed to meet the demands of a Phase 3 environment
• Collaborate with Functional Area stakeholders to develop and execute on risk-based annual Audit plans, including oversight of auditor assignments, audit tracking and timeline completion and filing of all audit documentation
• Provide strategic direction to staff supporting management of deviations, CAPAs, change control processes, training, document management, and Audit program management
• Lead the development of Quality System metrics, provide analysis related to Functional Area performance and compliance, and collaborate with Functional Area leadership to assess trends and initiate continuous improvement programs
• Oversee cross-functional collaborations to ensure Alector’s GxP validated systems align with the evolving needs of the organization and regulatory requirements, including system implementation, validation, and lifecycle maintenance
• Facilitate training and knowledge-sharing sessions to enhance user understanding and engagement with GxP Systems and QMS processes
• Lead proactive user communication and change management approaches supporting the implementation of system changes and deployment
• Serve as a liaison with commercial partners to fulfill requests for documentation
• Support regulatory inspections
• Foster a Quality culture by educating and providing support to all Functional Areas’ in their use of and compliance with Quality System requirements

• BS/BA, MS/MA, or PhD in a scientific discipline or related field
• 15+ years’ experience in the Pharmaceutical/Biotechnology industry, including at least 5 years leading Quality System teams and initiatives
• Expert knowledge of FDA, EMA, MHRA and ICH GxP regulations and guidelines
• Proficient with Veeva Systems and ComplianceWire
• Extensive experience in effectively managing deviations, CAPAs, change control, and product complaints to meet regulatory expectations while adhering to assigned timelines
• Expertise in the development and maintenance of controlled documents (Policies, SOPs, Work Instructions) to support Phase 3 and commercial environments
• Experience with Risk Management program and its framework
• Strong ability to communicate effectively with all levels of the organization within and outside of the department, including external vendors
• Excellent organizational skills, analytical and problem-solving abilities, and strong verbal and writing skills
• Able to operate in a dynamic, fast-growing biotech company with aggressive timelines
• Excellent people leader with strong coaching and mentoring skills
• Demonstrated problem-solving and critical thinking skills

At Alector, our vision is bold, people are our priority, and our values are at the core of everything we do. Our dynamic and flexible environment encourages our teams to experiment, take ownership of decisions, and question convention to solve complex problems. We value shared wins, perseverance, and a growth mindset, which drives us forward, together.  

Among the things you'll discover at Alector from your very first day are our committed and driven colleagues, a bold company vision, and new, modern offices designed to inspire innovation and collaboration in South San Francisco, right at the heart of Biotech Bay. Our benefits are thoughtfully designed around Alectorians and their loved ones and include flexible hybrid work options, competitive compensation, and comprehensive and unique benefits that enhance your health and well-being. Come join us! 

We believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each other’s assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws.  

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation. 

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