ALX Oncology Inc. (ALX) 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 (ALX148), 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.  

 

Reporting to the Executive Director of Quality and Compliance, the Senior Director of GxP Compliance and Inspection Management is a full-time position that is focused on leading the GxP audit, compliance, and inspection management program at ALX Oncology to ensure compliance with GxP regulatory requirements, current GxPs, and global Standards. This expert will define the GxP global audit process for external and internal audits and provide oversight of the GxP audit program including management of the annual GxP audit schedule, approved vendor list, and leadership of our auditors and contract audit organizations. Additionally, this leader will design the global health authority inspection management program, partner with cross-functional teams and vendors to ensure ALX Oncology is inspection-ready.


Responsibilities 

  • Develop and manage the GxP global internal and external audit processes and procedures that govern the programs.
  • Provide oversight of the GxP auditors to ensure the audit program is sufficiently robust to assess the quality, compliance standards and performance of vendors.
  • Develop and maintain a risk-based audit schedule for both internal functions and external vendors, in partnership with leadership and stakeholders. Ensure adherence to the schedule.
  • Evaluate internal and external audit findings and ensure timely identification and escalation of potential critical observations and compliance gaps are escalated to senior leadership. Support the cross functional teams to ensure remediation.
  • Ensure Quality issues are captured as appropriate in quality systems (eg, deviations, CAPAs) and followed through close out.
  • Ensure GxP audits are conducted to assess compliance with applicable regulations/guidelines, quality agreements, and SOPs.
  • Maintain the approved vendor list.
  • Design and execute the global health authority GxP inspection management processes and procedures in collaboration with internal and external operational teams and sites to ensure a state of inspection readiness.
  • Lead and support the cross functional teams during the preparation, execution, and closure of ALX health authority inspections and partner with vendors, and investigational sites to support external Inspections as appropriate.
  • Maintain understanding of the current compliance issues and trends and share relevant information to appropriate cross functional stakeholders.

 

Requirements

  • Bachelor’s Degree required.
  • Minimum of 15 years of relevant experience including audit and establishing/leading an inspection management program.
  • Demonstrate working knowledge of regulations, current GxPs, and global standards.
  • Demonstrate understanding and impact of industry trends, emerging regulatory compliance requirements and best practices via internal/external benchmarking for considerations into the Quality strategy.
  • Proven track record of developing and implementing audit and inspection management programs.
  • Ability to lead, facilitate and manage cross-functional teams comprised of internal and external stakeholders.
  • Strong influencing skills and creative problem-solving capabilities.
  • Strong presentation skills and an ability to communicate effectively at a variety of levels across the organization.
  • Demonstrates working knowledge of GxP Quality Management System fundamentals.
  • Experience in small to mid-sized biotech with an understanding of agile, phase appropriate and right sized Quality Management Systems.
  • Proven ability to think strategically and to translate strategy into actions.
  • Proficient in MS applications such as Power Point, Word, and Excel.
  • Exceptional teamwork and collaboration skills with internal and external parties.
  • Must be able to proactively provide real-time resolutions and approaches balanced with long-term objectives.
  • Acts with a sense of urgency and self-motivated with the ability to demonstrate initiative.
  • Willingness to work in a dynamic and changing corporate environment.

 

Salary: $230,000-$280,000 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. Hybrid work model acceptable (i.e., part-time in South San Francisco office 2-3 days/week with flexibility to work part-time from home).

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