Job DetailsCompany: At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barr syndrome, Huntington's disease and geographic atrophy, we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. At Annexon, you'll be part of a team committed to making an impact together. For more information on Annexon and our pipeline, check out our site Annexon Biosciences & Annexon Pipeline . We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane, CA. We seek applicants from all backgrounds to ensure we get the best, most creative talent on our team. We are building a diverse and inclusive workforce - come and be a part of our growth. At Annexon, we are building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may come from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply - especially if the reason you are the best candidate is not exactly as we describe it here. Learn more about Annexon's commitment to diversity, equity, inclusion our values and culture ! Position: The Senior Director, Quality Systems will serve as a subject matter expert and will assist in the implementation and maintenance of GxP compliant procedures and operations by managing the GxP systems including electronic document management system and learning management system. This hands-on position involves system validation, document control, and continuous improvement initiatives, while collaborating with cross-functional teams to maintain and enhance quality processes in alignment with regulatory requirements. Responsibilities include:
- 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
Education, Experience, and Skills: Required:
- 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
Salary Range: $228,000 - $255,000 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.
Annexon Biosciences is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind. We are committed to fostering an environment where ALL people are welcome and supported. We cultivate a culture of inclusion for all employees that respects their individual strengths, views, and experiences. We believe that our differences enable us to be a better team - one that makes better decisions, drives innovation, and delivers better business results. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect. Staffing Agencies: Annexon Biosciences does not accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesn't have a signed agreement with Annexon Biosciences. Please do not send agency CVs/resumes through Annexon's website or Annexon Employees. Inquiries must be sent to ...@annexonbio.com with the Subject: Staffing Agency Request.