Sr. Director, Quality Assurance

Annexon Biosciences; San Francisco (CA); Remote; USD 245,000 - 273,000; Full time

Job summary

An innovative biopharmaceutical company is seeking a Senior Director of Quality Assurance to lead compliance and quality operations. This pivotal role involves overseeing GMP activities, managing audits, and driving continuous improvement across processes. The ideal candidate will have extensive experience in quality assurance within the biotech sector, strong leadership skills, and a commitment to fostering an inclusive workplace. Join a team dedicated to advancing novel therapies and making a significant impact on patients' lives. If you're passionate about quality and compliance in a dynamic environment, this opportunity is for you.

Benefits

Flexible schedules

Remote work options

Work-life balance

Shuttle service from BART, CalTrain, Ferry

Competitive salary

Equity

Stock purchase plan

Health benefits

401(k)

FSA

Qualifications

• 10-15+ years in GMP, quality assurance, or manufacturing.
• Strong leadership and communication skills are essential.

Responsibilities

• Oversee GMP activities to ensure compliance with regulatory requirements.
• Manage and execute GMP audit programs and maintain documentation.
• Lead QA and QC teams, driving continuous improvement.

Skills

GMP Compliance

Quality Assurance

Leadership Skills

Communication Skills

Problem-Solving Skills

Cross-Functional Teamwork

Veeva Experience

Education

B.S./M.S. in Life Sciences

Experience in Biotech/Pharma

Job description

Join to apply for the Sr. Director, Quality Assurance role at Annexon Biosciences

Company: 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 scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts. Our therapeutic candidates aim to provide benefits across autoimmune, neurodegenerative, and ophthalmic diseases, with proof-of-concept data in Guillain-Barré syndrome, Huntington’s disease, and geographic atrophy. We are advancing our clinical trials to bring new treatments to patients quickly. Join us and be part of a team committed to making an impact.

We value diversity and are committed to building an inclusive workplace. We encourage candidates from all backgrounds to apply, even if they do not fit the traditional mold. Learn more about our diversity and inclusion efforts on our site.

Position:

The Senior Director, Quality Assurance (QA) is responsible for ensuring manufacturing and quality operations comply with regulatory and internal standards, leading QA/QC teams, managing audits, inspections, and driving continuous improvement across GMP processes.

Responsibilities include:

1. Oversee all GMP activities to ensure compliance with regulatory requirements (FDA, EMA, ICH, etc.) and internal standards.
2. Maintain and organize GMP documentation, systems, and records.
3. Manage and execute GMP audit programs, including qualifications audits, investigations, and inspection readiness.
4. Provide leadership for QA and QC teams, including hiring, training, and evaluations.
5. Approve batch disposition, deviations, change controls, and CAPA.
6. Lead cross-functional teams to resolve quality issues and implement process improvements.
7. Maintain and improve Quality Management Systems (QMS).
8. Collaborate with partners, including contract manufacturers, to meet GMP standards.
9. Prepare and present quality performance updates to senior management.
10. Oversee regulatory inspections and responses, and ensure GMP training programs.

Education, Experience, and Skills:

Required:

• B.S./M.S. in life sciences, biotechnology, or related field.
• 10-15+ years of experience in GMP, quality assurance, or manufacturing within biotech/pharma industries.
• Strong leadership, communication, and problem-solving skills.
• Ability to work effectively with cross-functional teams.
• Veeva experience is a plus.

Salary Range:

$245,000 to $273,000

Location:

Brisbane, CA, with preference for candidates in the San Francisco Bay Area. Remote work possible within the US.

Benefits:

• Flexible schedules, remote work options, work-life balance.
• Shuttle service from BART, CalTrain, Ferry.
• Competitive salary, equity, stock purchase plan, health benefits, 401(k), FSA, and more.

Annexon Biosciences is an Equal Opportunity Employer, committed to fostering an inclusive environment. We value diverse perspectives and experiences to drive innovation and better decision-making.