ALX Oncology is a clinical-stage and patient-focused immuno-oncology company developing therapies that block the CD47 myeloid 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.   


Position Summary

The GxP Learning and Document Management role will contribute to the success of business strategies and employee satisfaction by standardizing, optimizing and innovating personnel training and education while successfully managing knowledge and controlled documents through the document management system. This leader brings subject matter expertise and experience along with best practice knowledge to lead the development, implementation and continuous improvement of the learning and document management programs which will encompass use and optimization of the Quality Management System. This position resides within the Quality organization but spans the greater ALX Oncology organization by supporting cross functional learning plans and document management while providing opportunities to drive continuous improvement within the ALX Oncology Quality Management System.

 

Responsibilities

  • Lead the assessment, development, delivery, and maintenance of the GxP Learning Program in support of the Quality Management System. This will include developing supporting documentation, curriculum design, employee onboarding learning plans and a contractor training program. Will coordinate with internal and external subject matter experts for content development and implementation.
  • Lead the Document Management processes including the issuance, tracking, reconciliation, maintenance and retirement of controlled documents. This will include contribution to the authoring, coordination and review of a portion of documents, while coaching others in performing these activities to support their respective functional areas.
  • Coach and mentor others in the Quality Manual, document hierarchy and basics of the Quality Standards and QMS elements, as well as more in-depth coaching in Personnel Qualification methodologies and use of the Learning Management System (LMS) and the Electronic Document Management System (EDMS).
  • Business System Owner for the LMS and EDMS; leading the business process development and continuous improvement for the LMS and EDMS, managing system enhancements and change control process and timing, and develop and manage training for use of the LMS and EDMS. Will be managing access and permissions within both systems.
  • Identify and apply key elements of a learning and development program, including conducting a needs analysis incorporating adult learning principles, leading the development of Quality competency-based curricula and materials, and developing methods to determine effectiveness.
  • Manage the implementation and maintenance of the Quality Standard, SOPs, Work Instructions and or Forms for both the GxP Learning Program and the Document Management Program.
  • Work with key stakeholders to implement and sustain metrics to measure the health of the GxP Learning Program and Document Management Program, to identify areas for continuous improvement.
  • Create an environment that encourages transparency in communicating risks that may impact the team's ability to meet the objectives.
  • Exercise systems thinking to assess potential impact to processes/functions as a result of change implementation.
  • Develop solutions using risk-based methods to manage potential compliance risks and to build pragmatic approaches.
  • Build continuous improvement into daily activities by encouraging and expressing an environment of vulnerability and curiosity to ask questions and learn by listening. Practice humility not only in individual interactions but also while leading teams. Ensure lessons learned are incorporated into processes to encourage continuous improvement.
  • Provide support during internal and external audits as an SME to both regulatory health authorities and auditors regarding GxP learning programs, document management, systems, and records.
  • Manage resources and ensure their learning and development align with the needs of the ALX Quality Business Unit


Requirements

  • Bachelor’s Degree required in Biological Sciences, Chemistry, Engineering or related technical discipline, advanced degree or training in adult learning deployment or instructional design is a plus
  • Minimum of 12 years developing and deploying, efficient and effective GxP learning programs and document management programs, with a minimum of 3 years providing learning and development support to the Quality Organization.
  • Demonstrate understanding and impact of industry trends, emerging regulatory compliance requirements and best practices via internal/external benchmarking for considerations into the Quality strategy.
  • Experience with Learning Management Software and Electronic Document Management System. Would be a plus for Veeva system user/administrator experience.
  • Able to design, implement and maintain compliant cross-functional GxP learning and document control processes and tools
  • Ability to facilitate and lead cross-functional teams
  • Proven ability to think strategically and to translate strategy into actions
  • Proficient in Global cGMP’s and pharmaceutical industry practices
  • Proficient in MS applications such as Power Point, Word, and Excel
  • Strong influencing skills and creative problem-solving capabilities
  • 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
  • Lean six sigma/OE or similar experience
  • Hybrid work environment/telecommuting acceptable 

 

Salary: 

Associate Director:  $170,000-$195,000 DOE 

Director: $200,000-$240,000 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.


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