Director, Vendor Quality Management ~ GxP

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. 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 Director, Vendor Quality Management will be responsible for all Quality aspects of GxP Vendor Management and surveillance. Quality, compliance, and performance risks with Alector’s GXP vendors must be detected, mitigated, and controlled to ensure reliable delivery of processes and products in compliance with regulations and Alector’s specifications.The position requires close cooperation with QA team members (QA Operations and Clinical QA) and other departments.

Essential responsibilities include:

• Create and maintain a compliant Quality Vendor Management system to ensure vendor compliance with GxP regulations and risk management.
• Maintain the approved vendor list and associated processes.
• Participate in GxP vendor selection with SMEs to ensure vendor compliance with regulations and Alector’s specifications.
• Manage vendor qualification through risk-based audits and performance criteria.
• Oversee the GxP audit program, including audit planning, auditor selection, result monitoring, and corrective action follow-up.
• Negotiate, draft, and manage quality agreements with vendors, ensuring alignment with policies, regulations, and industry standards.
• Establish communication lines with vendors to keep Alector informed about vendor activities and services.
• Develop criteria and KPIs for vendor performance and establish a monitoring program.
• Participate in Alector’s Quality initiatives, including internal audits, SOP development, and inspection readiness programs.

Requirements:

• BS/BA, MS/MA, or PhD in a scientific or technical discipline or related field. MBA or similar experience is desirable.
• 10+ years’ experience in the Pharmaceutical/Biotechnology industry, including relevant experience working in Quality Assurance or GMP production using external cooperation partners.
• Working knowledge of biotechnical manufacturing and testing processes.
• Working knowledge of Good Clinical Practices
• Expert knowledge of FDA, EMA, MHRA and ICH GxP regulations and guidelines.
• Strong collaboration, team-building, and organizational skills
• Strong negotiation skills with internal and external partners
• Excellent written and verbal communication skills
• 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.
• Demonstrated problem-solving and critical thinking skills