ALX Oncology is a clinical-stage immuno-oncology company focused on helping patients fight
cancer by developing therapies that block the CD47 checkpoint pathway. Our lead candidate,
evorpacept, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47
binding domain with an inactivated proprietary Fc domain. For more information about us,
please visit www.alxoncology.com.
ALX Oncology is seeking an experienced self-driven Quality Assurance Manager or Specialist with up-to-date
knowledge and demonstrated experience to all applicable cGMP standards and regulations.
This impactful position will report to the head of CMC QA/QC. The individual will ensure cGMP
compliance of contract manufacturers and testing laboratories, cooperate with QA/QC
personnel at contractors and internal stakeholders to meet manufacturing, testing, and project
timeline.
Key Responsibilities
- Review and approve documentation associated with GMP manufacturing activities
conducted at contract manufacturers to ensure accuracy and compliance with
applicable regulatory requirements. The documents include but are not limited to
master and executed batch records for drug substance, drug product, and
labeling/packaging of investigational products. - Interact with CMO colleagues to ensure that ALX QA documentation requirements are
met in advance of batch disposition. - Review and approve documentation associated with lot disposition, raw material and
product specifications, labels, change controls, deviations, investigations, and CAPA. - Evaluates the effectiveness of Contractors’ quality systems by tracking Contractor’s key
performance indicators, audit outcome and response, identified or potential compliance
issues/risks. - Lead or assist with quality audits to ensure that studies/operations are conducted in
accordance with protocols/procedures, cGMP, industry guidelines, and applicable
regulations. - Assist in developing, refining, and managing internal ALX Quality Systems.
Requirements
- Minimum BA/BS in life science related field.
- 5 + years experiences in biopharmaceutical industry with at least 3 years’ experience in
QA batch record review and lot disposition. - Knowledgeable and proficient in application of QA systems principles and standards, current industry practices, and applicable regulations including 21 CFR Parts 210, 211, 600, and related Annexes, and ICH guidance documents.
- Ability to perform detail-oriented work with a high degree of accuracy.
- Effective time management, organizational and planning skills to manage multiple tasks, produce quality work and consistently meet deadlines.
- Demonstrated sound decision-making and problem-solving skills.
- Ability to interact effectively with all stakeholders and facilitate decision-making, work effectively in cross-multifunctional teams.
- Proficient in common computer programs (e.g., Word and Excel)
- Domestic and/or international travel may be required up to 10% of work time.
- Hybrid work or Remote working model acceptable
- Must show proof of full COVID-19 vaccination to attend onsite at our South San Francisco office.
Salary: $120,000-145,000 DOE
ALX Oncology is an equal opportunity employer. All applicants should be legally entitled to work for any employer in the US. Title and salary are commensurate with experience. Our compensation program includes competitive salary, equity participation and attractive bonus incentives.