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Director/Sr. Director Quality Assurance
Job Description

Company Summary
Annexon Biosciences is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, eye and brain. The Company’s pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. The Company’s first product candidate, ANX005, is a full-length monoclonal antibody formulated for intravenous administration in autoimmune and neurodegenerative disorders. The Company’s second product candidate, ANX007, is a monoclonal antibody antigen-binding fragment (Fab) formulated for intravitreal administration for the treatment of neurodegenerative ophthalmic disorders. Based on learnings from its initial trials, Annexon is advancing its current programs while evaluating additional orphan and large market indications. Annexon is deploying a disciplined, biomarker-driven development strategy designed to establish that each of its product candidates is engaging the specific target at a well-tolerated therapeutic dose in the intended patient tissue.

Desired Candidate Profile
Quality Assurance (QA) Senior Director/Director to lead the company’s clinical Quality Assurance (cQA) program. The incumbent will assist in the development of quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures and protocols.
The incumbent is also responsible for developing specific internal procedures, training of staff and hosting regulatory inspections. The position involves managing clinical quality operations and liaison of clinical quality related issues with Annexon’s functional areas. The candidate will perform audits of vendors, study sites, and internal processes.
The successful candidate must have the ability to execute QA tasks independently; effectively represent QA in a GCP focused team setting and manage quality related activities at clinical vendors, investigator sites and regulatory agencies. In addition, the candidate must actively manage an appropriate level of inspection readiness of Annexon’s clinical stakeholders and act as a catalyst for continuous process improvement.

Specific Responsibilities
• Oversee the development and maintenance of GCP related quality system SOPs in compliance with all applicable regulatory requirements and to align with existing company policies
• Ensure clinical trials are performed in accordance with applicable study protocols and are in compliance with all applicable regulatory requirements
• Manage contractors
• Manage/oversee all aspects of cQA at clinical vendors
• Create/manage/maintain quality plans for the cQA function
• Manage staff performing quality reviews of clinical study documents, which include investigator brochures, clinical protocols and clinical study reports, case report forms and informed consents forms
• Manage staff performing internal audits to ensure stakeholder system compliance with existing policies and procedures, and GCP requirements, standards and guidelines
• Provide expert CQA advice and strategic guidance to stakeholders (e.g., Clinical Operations, Clinical Development, Data Management, Pharmacovigilance, etc.) based on analysis and interpretation of applicable GCP regulations
• Support the administration of the company’s training program by overseeing the conduct of GCP training to internal departments and externally, as applicable
• Manage/conduct targeted training of investigators/site staff
• Report GCP related deficiencies to senior management as well as plans for corrective and/or preventive actions (CAPA)
• Assist clinical study teams in the development of CAPAs
• Assist with tracking GCP compliance audit trends and group metrics and presenting metrics driven data to upper management
• Coordinate responses to regulatory agency inspections
• Review regulatory submissions for clarity and compliance with current regulations

Key Qualifications
• B.S./M.S. in relevant science field
• 10+ years of progressive global quality/regulatory compliance background in pharma/biotech and medical device industries, with a hands-on role in quality operations and quality systems
• Current and strong working knowledge interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research
• Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance
• Position requires a highly diplomatic, tactful and detail-oriented individual with excellent critical reasoning skills
• Ability to use expertise and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways
• Ability to deal with ambiguity, creative and pragmatic approach to problem solving
• Auditor certifications a plus
• Thorough understanding of GCP ICH Guidance requirements and related GCP regulations. Working knowledge of GMP and GLP regulations a plus
• Annexon’s Director/Sr. Director Quality Assurance will be required to be fully vaccinated against the Covid-19 virus.  An applicant is considered fully vaccinated two weeks after their second dose in a 2-dose series, such as the Pfizer or Moderna vaccines, or two weeks after a single-dose vaccine, such as Johnson & Johnson’s Janssen vaccine.  You will be required to show proof of vaccination status upon hire. The Company provides reasonable accommodations in accordance with applicable state, federal and local laws.

 

Annexon is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.