Director, Quality Assurance

REVOLUTION Medicines, a clinical stage biotech company dedicated to discovering and developing new drugs that translate frontier cancer targets through exceptional drug discovery delivering revolutionary medicines on behalf of cancer patients.  Our innovative science draws inspiration from nature and evolution, which offer insights into cancer targets, disease mechanisms and therapeutic approaches.  As a new member of the RevMed team, you will join other outstanding scientists who are helping lead our efforts in the discovery and development of new medicines for unmet needs in cancer.

Playing a critical role within the RevMed Development organization, the Head of Quality Assurance will lead the development, implementation and oversight of the company’s quality systems and ensure an appropriate level of effectiveness and compliance with GxP and other relevant ICH, US and EU regulations.  The position will also be responsible for managing quality operation, training and infrastructure, in addition to performing internal and external audits.  The candidate will provide strong leadership and expertise in setting and maintaining compliance standards.

Opportunity
  • Assure high standards of Quality in all aspects of Research and Development, including GMP, GCP and GLP compliance.

  • Foster a culture of continuous improvement in all aspects of GxP Quality, including the development and administration of policies and practices that address quality issues throughout the organization.

  • Develop and maintain GCP, GLP related quality system SOPs, and maintain GMP related quality system SOPs, in compliance with all applicable regulatory requirements and as appropriate for the company’s current needs.

  • Provide GxP QA oversight of external vendors’ quality programs, including negotiating and maintenance of quality agreements and vendor compliance.

  • Ensure the clinical trials, preclinical/nonclinical studies and manufacturing campaigns are performed in accordance with applicable protocols and in compliance with applicable regulatory requirements.

  • Evaluate quality events/incidents/issues and perform risk analysis, identify remediation actions and communicate to management or other stakeholders, as appropriate.

  • Manage/conduct external quality audits of clinical sites, clinical and preclinical vendors, CMOs and other manufacturing vendors.

  • Manage/conduct internal audits to ensure compliance with policies, procedures, GxP requirements and guidelines.

  • Design and oversee the company’s training program.

  • Provide expert GxP advice to internal stakeholders.

Required Skills
  • Bachelor’s degree in a relevant scientific or technical discipline.  An advanced degree and directly relevant professional certification are desirable.

  • Minimum 10 years of experience in the pharmaceutical industry with at least ten years at the management level with responsibility for manufacturing/GMP and/or GCP QA/QC.   

  • Proven track record of leadership and management is required.

  • Strong knowledge of GCP, ICH, FDA, EMA, as well as other relevant US and international regulatory requirements.  Broad understanding and experience in GxP and QA principles and industry standards are desirable.

  • Experience with small molecule development programs from early-stage to late clinical stage is preferred.

  • Ability to build consensus among colleagues with an appropriate level of flexibility, while maintaining a focus on results and goal attainment.

  • Ability to constructively relay analytical and technical insight/expertise.

  • Strong interpersonal, teamwork, and organizational skills, as well as effective oral and written communication skills.

  • Travel will be required.


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