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Vice President
3 months ago
Work Location
Corporate Headquarters (South San Francisco, CA) - Hybrid
Non Local Candidates will be considered
Position Summary
Annexon Biosciences seeks a VP of Quality who is responsible in having end-to-end Quality responsibilities inclusive of leading GMP, GCP, and GLP functions. The incumbent will be responsible for overseeing and participating in the development, implementation and maintenance of quality management practices and systems as governed by GCP, GMP, and GLP (GxP) regulations, to ensure compliance with internal policies, business objectives, procedures, and external regulations and standards. The incumbent is also responsible for developing specific internal procedures, training of staff, and hosting regulatory inspections.
The successful candidate must have the ability to execute QA tasks independently; effectively represent QA department both internally and externally while managing day to day quality related activities. In addition, the candidate must actively manage an appropriate level of inspection readiness and act as a catalyst for continuous process.
Responsibilities
Lead regulatory inspections, audits, and quality assessments, ensuring readiness and compliance with FDA, EMA, and other regulatory agencies with relevant regulations, directives and ICH guidelines
Drive quality risk management initiatives, identifying and mitigating potential risks to product quality, patient safety, and regulatory compliance. Provide strategic guidance and support for product quality issues, deviations, investigations, and recalls, as needed
Schedules and leads regular Quality Management Reviews on the status of compliance. Establish and monitor quality metrics and key performance indicators for the Quality department. Prepare regular reports and presentations for senior/executive management highlighting quality performance, trends, and areas for improvement
Oversee the design, implementation, and maintenance of robust quality management systems, including document control, deviation management, CAPA (Corrective and Preventive Action), and change control
Implement the appropriate suite of Standard Operating Procedures (SOPs), quality manuals, policies, and other related quality documents. Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders
Develop training curricula based on the key elements of the Quality System; Provide leadership and oversight for training programs. Ensure that employees and relevant stakeholders receive appropriate training on quality standards, regulations, and procedures
Collaborate with cross-functional teams, including clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments. Build and maintain effective relationships with internal and external stakeholders, including regulatory agencies and service providers
Qualifications
Undergraduate or graduate degree(s) in pharmacy, chemistry, biology, or related scientific field; advanced degree (e.g., Master's or PhD) preferred
Minimum of 18 years of experience with at least 5 years in a senior leadership position
Current in-depth knowledge, interpretation and implementation of GXP, United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements
Excellent leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively across functions and levels of the organization
Proven track record of successfully leading quality assurance teams and driving continuous improvement initiatives. Strong understanding of quality risk management principles
Ability to deal with ambiguity and use expertise and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways
Some travel required, including both domestic and international (20-30%)
What Annexon offers
Diversity, Equity, Inclusion, and Belonging are important to us. We believe that diversity, equity, inclusion and belonging are essential for the strength of our business and the vitality of the communities we serve. To learn more about our diversity commitment, culture and values, visit
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.
Company Summary
Annexon Biosciences (Nasdaq: ANNX) is 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. Annexon's 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-Barré syndrome, Huntington's disease and geographic atrophy, Annexon is rigorously advancing its mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. To learn more visit
EEO Employer – Annexon highly values Diversity, Equity, Inclusion and Belonging
Annexon Biosciences is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment based on race, color, religion, national origin, age, gender, sex, ancestry, citizenship status, mental or physical disability, genetic information, sexual orientation, veteran status, or military status. We are proud to promote a work environment where everyone, from any background, can do their best work.
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 with the Subject Heading: Staffing Agency Request.
