Associate Director, Quality Assurance

AVENZO THERAPEUTICS INC • San Diego, CA

4d • $161,000 - $180,000 • Hybrid

About The Position

Reporting to the Senior Vice President, Regulatory Affairs the Associate Director, Quality Assurance will partner cross-functionally with internal teams and external contract manufacturers and vendors to ensure compliance with Good Manufacturing Practice (GMP) standards, regulatory requirements, and internal procedures, while providing quality oversight of clinical manufacturing activities. This role may also provide support for the development and implementation of Avenzo Therapeutics’ Quality Management System.

Requirements

• Bachelor’s degree in chemistry, biology required, or a related area degree preferred (e.g., MBA) with 8+ years of progressive experience in Quality Assurance and related roles in the life sciences industry or an equivalent combination of academic and industry experience
• Experience supporting internal audits and health authority inspections (GCP, GMP, GLP)
• Experience supporting electronic QMS platforms, (e.g., Veeva)
• Strong knowledge of GMP, SOPs, and quality system and regulatory requirements (21 CRF Part 11/210/211, FDA)
• Proven ability to lead process improvement initiatives and drive continuous improvement initiatives
• Proficient in Microsoft Office, SharePoint, Teams, and electronic document management / QMS systems
• Ability to work independently and cross-functionally, building effective relationships across teams and time zones
• Experience in release of clinical trial materials preferred
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
• Strong analytical and problem-solving abilities, with a strategic mindset

Responsibilities

• Author, review, and approve GMP documentation (e.g., SOPs, specifications, protocols, reports, investigations) to ensure compliance with regulatory and internal standards
• Provide Quality Assurance (QA) oversight of contract manufacturers and vendors, including qualification, audits, and tracking of audit observations
• Partner with Chemistry, Manufacturing, and Controls (CMC) teams and Contract Manufacturing Organization (CMOs) to investigate and resolve quality events, including deviations and CAPAs
• Review and approve batch records, labeling, and distribution documentation; perform GMP release of clinical trial materials
• Maintain Quality Technical Agreements (QTAs) and approved supplier/vendor lists
• Support GMP systems to ensure compliance with 21 CFR Part 11, Annex 11, and validation requirements
• Develop and maintain tracking tools for quality activities and generate metrics and trend reports
• Support the document management system, including routing, approval, distribution, and archival of controlled documents and records (GMP)
• Support the GMP training program, including assignment, tracking, and compliance
• Drive GMP inspection readiness and identify opportunities for continuous improvement across quality systems and processes
• Support implementation and maintenance of QMS processes, including document control, CAPA, deviations, change control, and complaints

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Basic life and AD&D insurance
• Short-term disability insurance
• Long-term disability insurance
• Flexible spending accounts
• Health savings accounts
• Voluntary insurance programs (voluntary life, AD&D accident, critical illness)
• 401(k) plan
• Paid vacation time
• Paid sick leave
• 17 paid holidays each calendar year, including a winter closure

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level