Associate Director, Quality Assurance

About the role

Avenzo Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing next-generation oncology therapies. 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.

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

Qualifications

• 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
• 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

Preferred Qualifications

• Experience in release of clinical trial materials preferred

Physical Demands and Work Environment

• Constant or continuous use of a computer keyboard, monitor, and mouse to perform a variety of tasks
• Constant or frequent sitting, standing, or walking
• May lift and/or move objects of various weights
• No specific physical demands or work environment described beyond those listed above

Benefits

• Group healthcare plans that offer medical, dental, vision, and basic life and AD&D insurance
• Short-term and long-term disability insurance
• Flexible spending accounts
• Health savings accounts
• Voluntary insurance programs, including voluntary life, AD&D accident, and critical illness
• 401(k) plan
• Paid vacation time and sick leave
• 17 paid holidays each calendar year, including a winter closure

Other Compensation

• Annual discretionary bonus
• Equity award

Equal Employment Opportunity

Avenzo is committed to providing equal employment opportunities to all employees and applicants without regard to an individual’s actual or perceived protected characteristic or characteristics, or any combination of protected characteristics including race (including traits associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniformed service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), the employee or their family member’s status as a victim of a qualifying act of violence, political activity or affiliation, use of cannabis off the job and away from the workplace, association with an individual who has, or is perceived to have, a protected characteristic or characteristics, or any combination of protected characteristics, or any other protected status in accordance with all applicable federal, state, and local laws.