Senior Vice President of Quality Assurance

2 weeks ago

South San Francisco, California, United States Annexon Bioscience Full time
Work Location

Corporate Headquarters - Hybrid

Position Overview

Annexon Biosciences is in search of a Senior Vice President of Quality Assurance who will take charge of comprehensive Quality responsibilities, encompassing the leadership of GMP, GCP, and GLP operations. This role entails overseeing the formulation, execution, and upkeep of quality management practices and systems, ensuring adherence to GCP, GMP, and GLP (GxP) regulations, as well as compliance with internal policies and external standards. The successful candidate will also be tasked with developing internal procedures, training personnel, and facilitating regulatory inspections.

The ideal candidate must possess the capability to independently execute QA responsibilities, effectively represent the QA department both internally and externally, and manage daily quality-related activities. Additionally, the candidate should actively maintain a suitable level of inspection readiness and drive continuous process improvement.

Key Responsibilities
  • Oversee the development and execution of the vision and strategy for the quality function, including budget management. Ensure regulatory compliance and serve as a subject matter expert for quality investigations, documentation systems, training programs, and audits.
  • Lead regulatory inspections, audits, and quality assessments, ensuring compliance with FDA, EMA, and other regulatory bodies.
  • Initiate quality risk management efforts, identifying and addressing potential risks to product quality and patient safety. Provide strategic support for product quality issues, deviations, investigations, and recalls.
  • Conduct regular Quality Management Reviews to assess compliance status. Establish and monitor quality metrics and key performance indicators for the Quality department, preparing reports for senior management.
  • Oversee the design and maintenance of robust quality management systems, including document control, deviation management, CAPA (Corrective and Preventive Action), and change control.
  • Implement a comprehensive suite of Standard Operating Procedures (SOPs), quality manuals, and related documents, ensuring effective communication and adherence among stakeholders.
  • Develop training programs focused on key elements of the Quality System, providing leadership and oversight to ensure all employees receive appropriate training on quality standards and regulations.
  • Collaborate with cross-functional teams, including clinical operations and regulatory affairs, to build and maintain effective relationships with internal and external stakeholders.
Qualifications
  • Undergraduate or graduate degree(s) in pharmacy, chemistry, biology, or a related scientific discipline; advanced degree preferred.
  • A minimum of 18 years of experience, with at least 5 years in a senior leadership role.
  • In-depth knowledge of GXP, United States Code of Federal Regulations, ICH Guidelines, and local regulatory requirements.
  • Exceptional leadership, communication, and interpersonal skills, with the ability to influence and collaborate across various functions.
  • Proven success in leading quality assurance teams and driving continuous improvement initiatives, with a strong grasp of quality risk management principles.
  • Ability to navigate ambiguity and leverage expertise to contribute to the development of company objectives and achieve goals effectively.
  • Some travel may be required, including domestic and international travel.
What Annexon Offers
  • Diversity, Equity, Inclusion, and Belonging are integral to our mission. We believe that these values are essential for the strength of our business and the vitality of the communities we serve.
  • A dynamic and rewarding workplace featuring flexible work schedules and remote opportunities to promote work-life balance.
  • Annexon provides a competitive base salary, equity participation, and a comprehensive health benefits package, including medical, dental, vision, 401(k), and flexible spending plans.
Company Overview

Annexon Biosciences is a biopharmaceutical company dedicated to advancing innovative therapies for individuals affected by severe classical complement-mediated neuroinflammatory diseases. Our unique scientific approach targets upstream C1q to inhibit the classical complement inflammatory cascade, with therapeutic candidates designed to offer significant benefits across various autoimmune, neurodegenerative, and ophthalmic conditions. We are committed to rigorously advancing our clinical trials to deliver new potential treatments to patients efficiently.

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