Associate Director, Quality Assurance

Associate Director, Quality Assurance

Avenzo Therapeutics, Inc. ("Avenzo" or "Company") is a clinical-stage biotechnology company focused on developing next-generation oncology therapies for patients. The Company was co-founded in 2022 by Drs. Athena Countouriotis and Mohammad Hirmand. Our team is passionate about and committed to advancing a pipeline of potentially differentiated targeted oncology programs that make a difference in the lives of people with cancer. The Company is headquartered in San Diego, California.

Position Summary

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.

Essential Job Functions and 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

Preferred 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
• 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
• This position requires periodic/regular travel, including up to 15% of work time, which may include overnight travel

Physical Demands and Work Environment

Physical Demands:

• 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

Work Environment:

• Remote: Home office; expected to travel to and work from the Company's headquarters in San Diego from time to time
• San Diego-based: On-site requirement (Monday through Thursday)
• Noise level in the work environment is usually moderate
• Fast-paced, time sensitive environment with frequently changing priorities
• Handle multiple projects simultaneously

Reasonable accommodations may be provided to enable qualified individuals with disabilities to perform the essential functions of the position.

Salary Range

The salary range for this position is $161,000 to $180,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and years of experience within the job and the industry, education, and skills and certifications.

Benefits

Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life and AD&D insurance. Additional benefit programs include short-term and long-term disability insurance, flexible spending accounts, health savings accounts, and voluntary insurance programs, including voluntary life, AD&D accident, and critical illness. Employees will also be able to enroll in the Company's 401(k) plan. In addition, employees will accrue 10 hours of paid vacation time every month and accrue 1 hour of paid sick leave for every 30 hours worked. Employees also enjoy 17 paid holidays each calendar year, including a winter closure, subject to applicable Company policies. All benefits are subject to the terms and conditions of the applicable plan documents and Company policies, which may be amended from time to time.

Other Compensation

The hired candidate will be eligible to receive an annual discretionary bonus and an equity award, subject to the terms of the applicable employment agreement, plan documents, and Company policies.

The information above is intended to provide a general description of benefits and other compensation and is not a substitute for applicable plan documents or company policies.

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.

Notice to Search Firms/Third Party Agencies

Avenzo does not accept unsolicited resumes from recruiters, employment agencies or search firms without a valid, executed search agreement in place.