Vice President (Head), Quality

 

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

• Overall responsibility for the development and implementation of the vision and strategy, as well as the budget for the quality function.  Ensures quality and operational regulatory compliance; acts as a subject matter expert for quality investigations, documentation systems, training programs, and internal/external audits
• 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 https://annexonbio.com/careers/
• 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 annexonbio.com.

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  talentacquisition@annexonbio.com with the Subject Heading:  Staffing Agency Request.