Full-Time

Director – Vendor Quality Management ~ Gxp

Posted on 11/28/2024

Alector

Alector

201-500 employees

Develops therapies for neurodegenerative diseases

Biotechnology
Healthcare

Compensation Overview

$211k - $228kAnnually

Senior, Expert

San Bruno, CA, USA

Hybrid position in South San Francisco, CA.

Category
Public Health
Biology Lab & Research
Biology & Biotech
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
Responsibilities
  • 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.

Alector develops therapies aimed at treating neurodegenerative diseases like Alzheimer's and Parkinson's. The company focuses on research and development of new drug candidates by utilizing knowledge from immunology, neurology, and human genetics. Their approach involves conducting early-stage clinical trials to gather specific data about diseases, which helps improve the chances of success for their treatments. Alector differentiates itself from competitors by emphasizing the body's natural healing processes in their drug development. The company's goal is to create effective treatments for conditions that currently have limited options, thereby addressing significant medical needs in the healthcare sector.

Company Stage

IPO

Total Funding

$189.2M

Headquarters

San Francisco, California

Founded

2013

Growth & Insights
Headcount

6 month growth

0%

1 year growth

4%

2 year growth

-8%
Simplify Jobs

Simplify's Take

What believers are saying

  • The recent $75 million financing round strengthens Alector's financial position, enabling further R&D efforts.
  • FDA Breakthrough Designation for latozinemab, developed in collaboration with GSK, highlights the potential impact of their therapies.
  • The appointment of experienced leaders from companies like Genentech and Kura Oncology bolsters Alector's executive team, enhancing strategic direction and operational execution.

What critics are saying

  • The biopharmaceutical industry is highly competitive and capital-intensive, requiring continuous investment to sustain R&D efforts.
  • Dependence on successful clinical trial outcomes and regulatory approvals poses significant risks to the commercialization of their therapies.

What makes Alector unique

  • Alector leverages a unique combination of immunology, neurology, and genetics to develop therapies, setting it apart from competitors who may focus on just one of these areas.
  • Their strategic partnerships with major pharmaceutical companies like GSK and AbbVie enhance their R&D capabilities and accelerate the commercialization of their therapies.
  • Alector's focus on early-stage clinical trials and rapid data collection increases the probability of success for their therapeutic candidates.

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