Remote Senior Director

Summary

Join Annexon Biosciences, a biopharmaceutical company advancing novel therapies for devastating classical complement-mediated neuroinflammatory diseases. We seek applicants from all backgrounds to ensure we get the best, most creative talent on our team.

Requirements

• Bachelor’s Degree in a related discipline with a broad knowledge of biologics, device or drug development and at least ten (12) years industry experience related to GxP systems
• Knowledge of and proficiency with electronic document management systems (Veeva Vault experience is highly desired)
• Strong problem-solving and communication skills
• Ability to work independently and as part of a team
• Strong organization and time management skills

Responsibilities

• Hands-on role implementing, maintaining, and enhancing the electronic systems throughout its lifecycle as it relates to Quality (EDMS, LMS, etc.)
• Contribute to the validation activities of GxP computerized systems, demonstrating expertise in both Computer System Validation (CSV) and the Computer Software Assurance (CSA) activities
• Accountable for maintaining GxP systems in their validated state
• Identify and support continuous improvement opportunities within Quality Systems
• Monitor, generate, analyze and report out Quality metrics to relevant stakeholders aimed to ensure the health of the quality system
• Set up and manage the document control process and ensure all controlled documents are appropriately stored, distributed, and archived in accordance with company and regulatory requirements
• Implement 21 CFR Part 11 compliance and ensure all electronic records and signatures are in compliance with regulations
• Set up relevant staff on Veeva Vault and ensure all document control processes are appropriately managed within the system
• Assist in the creation of training curricula and ensure all Annexon personnel are trained on relevant document control procedures
• Work with cross functional teams to ensure all documents are reviewed, approved, and trained on in a timely manner
• Conduct periodic audits of document control processes and ensure any non-conformances are appropriately addressed
• Participate in the development and implementation of new document control procedures as needed
• Maintain knowledge of current industry and regulatory trends related to document control and ensure company processes remain up to date and compliant
• Support and participate in other duties as assigned by management including but not limited to audits and inspections, supplier quality management, quality risk management, and quality management systems

Benefits

• A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance
• We are located in Brisbane, CA, with shuttle service from BART, CalTrain and the Ferry
• Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, as well as other benefits