JOB POSTING

Director, Quality Assurance / Quality Control

ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway. Our lead candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents.

This position will report to the Vice President of Chemistry, Manufacturing, and Controls and will be responsible for providing quality oversight of CMOs providing manufacturing and clinical depot services. The candidate will lead and manage all aspects of QA/QC and be responsible for quality-related activities to enable release of drug substance, drug product, and finished goods. The individual will maintain and improve the Quality Management System (QMS) through continuous development, implementation, and maintenance of quality standards, policies and procedures incorporating phase-based flexibility that ensure rigorous regulatory compliance.

Responsibilities

  • Develop and maintain Quality Management Systems.
  • Perform routine Quality system activities including drafting, reviewing, and approving: SOPs, master and executed batch records, analytical methods, deviations, investigations, CAPAs, change control, OOS, and process and method validation plans and completed reports.
  • Lead Quality Management activities such as quality agreements, vendor qualifications, quality and CMO audits.
  • Monitoring, review, and assessment of ongoing stability test results and summary reports.
  • Proactively identify compliance issues/risks, within the organization and with external partners.
  • Hire and manage Quality Assurance staff.   Oversee any Quality consultants and manage other related vendors.
  • Lead in the preparation and quality/compliance review of BLA/IND/IMPD regulatory submissions for US and worldwide health agencies.
  • Collaborate with Process Development and Technical Manufacturing teams for new biologic product introductions and provide quality leadership throughout all phases of product development.
  • Provide oversight and direction bringing a biologics product from Phase 1 to a successful BLA approval.
  • Ensures a risk-based supplier quality program is in place and maintained, appropriate for stage of clinical development.

Requirements

  • Demonstrated success in making informed decisions for a QA/QC department.
  • Ability to prioritize and handle multiple activities on a daily basis yet flexible and responsive to frequently shifting priorities.
  • Demonstrates excellent verbal, written, and interpersonal communication skills, as well as excellent influencing skills.
  • Demonstrated ability to accomplish stated goals through others without direct supervision.
  • Strong sense of ethics and honesty.
  • Strong interpersonal, teamwork, organizational and workload planning skills.
  • Expert knowledge of GMPs, FDA and EMA regulatory requirements applicable to biologics.
  • Excellent problem-solving skills and experience with root cause investigations and CAPA determination.
  • Has the experience and confidence necessary to work with senior executives, and the ability to build rapport with employees at all levels.
  • Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.
  • Up to 15% travel time required.

Education & Experience

  • 15 years of relevant Quality Assurance and Quality Control experience in biopharmaceuticals, biotech or pharmaceuticals industry, and a Bachelor’s degree in science or related fields or 12 years of relevant experience and an advanced science degree such as MS, MD, PharmD.
  • Demonstrated experience building and leading exceptional Quality Assurance and Quality Systems teams.
  • Extensive knowledge and experience in Quality Assurance and Control in highly regulated manufacturing environments.
  • Broad experience across areas such as CMO QA, QC, validation, drug development.
  • Proficiency of parenteral, aseptic and biologics DS operations.
  • Previous experience in bringing development products through clinical phase to commercial licensure.
  • Prior experience managing analytical development and product characterization is preferred.

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.

To apply for this position, please send your cover letter and resume to hr@alxoncology.com