Job Openings | Aveo Oncology


Associate Director, GMP, QA

Job Title
Associate Director, GMP, QA
Job ID
Work Hybrid
Boston,  MA 02108
Other Location
Position: Associate Director GMP Quality
Department: Quality Assurance
Reports to:   Sharon Reinhard
Location:  Boston / remote

The Associate Director of GMP Quality Operations and Compliance will support the GxP Area Head in managing a complex network of external contract manufacturing and CMC vendor along with supporting internal product development teams. This position will assist in the evaluation, selection and onboarding of new GxP vendors, in the execution of the annual audit program, the development and maintenance of quality operations and compliance standards, review of key regulatory submission documents, and review of commercial and research manufacturing documentation.

  • Responsible for the development and implementation of GMP/CMC/Product Development/Commercial related Global SOPs/Standards/Guidelines with respect to Quality Systems Management and ensure alignment with AVEO Quality philosophy, phase of development, and industry best practices
  • Oversee the execution of or conduct audits and oversight activities identified in the annual GMP/CMC audit and oversight program (commercial/research), including but not limited to:
    • Annual/bi-annual questionnaire program
    • Vendors
    • Documents
    • Processes
    • Facilities
    • Quality oversight activities
  • Provide quality oversight of elements of the Quality System/ Quality Management System for their GxP area(s) for work conducted internally and/or externally (commercial/research), including but not limited to
  • Procedural documents
  • Change Control
  • Deviation / CAPA management
  • Issue Management
  • Monitoring KPIs/KQIs
  • Create strong partnerships with external GxP contract organizations to ensure compliance with applicable guidelines and regulations.  Proactively and effectively communicate with contract manufacturers to address and resolve complex and routine activities while building positive client/vendor relationships, fostering continuous improvement, and adding value to our internal CMC team
  • Represent Quality in various internal teams to ensure understanding of timing of deliverables
  • Participate in evaluating risk for assigned commercial/research programs including risk identification, scoring and register.
  • Assist in developing content for the Quality Management Review (QMR) meetings
  • Quality oversight of commercial and clinical trial material manufacturing, including but not limited to:
    • Review and approve master batch records, master labeling records, product specifications, stability protocols, stability reports, and other process related documents from contract sites.
    • Perform batch disposition through batch record and data review/approval and managing process deviations for timely release.
  • Participate in the review of key regulatory submission documents (e.g IMPDs, DSURs, INDs, BLAs and associated technical documents as needed)
  • Drive GMP/CMC inspection readiness activities for assigned projects
  • Contribute to the development of AVEOs quality and compliance focused culture

Competencies, Skills and Knowledge:
  • 12+ years Pharmaceutical company experience combined between roles in Quality Assurance  and/or in an manufacturing/CMC operational related role. Experience with biologics required.  Experience with both research and commercial products preferred
  • Knowledge and experience in interpretation of regulations, guidelines, policy statements, etc.
  • Previous experience with inspection management preferred
  • Self-confident, proactive and decisive
  • High ethical standards as well as acknowledged personal credibility, the ability to gain trust at the senior executive level
  • Visible and credible advocate for compliance and quality concepts with excellent communication skills across all levels of the business
  • Analytical and logical, is able to design and implement innovative, significant and complex business improvements
  • Ability to think strategically and to quickly analyze complex circumstances and problems, and to drive appropriate decisions, actions and resolutions
  • Experience of working in global cross functional teams, demonstrated ability in mentoring/ coaching/ directing staff to be quality advocates, influencers, leaders
  • Demonstrated ability to provide vision and leadership within teams, internally cross-company and externally with stakeholders
  • Experience in Quality Systems e.g. Deviation, CAPA and Change management processes
  • Sound customer focus, strong organization, communication (written and oral), influencing and negotiation skills
  • Proficient in English, MS Office applications and eQMS systems

Undergraduate degree (BA/BS) in Scientific discipline/Life Sciences or similar. Advanced degree preferred.

AVEO Oncology (“AVEO”) is an oncology-focused biopharmaceutical company committed to providing innovative solutions to improve cancer patients lives. On January 20, 2023, AVEO was acquired by LG Chem, Ltd. (“LG Chem”), establishing a U.S. commercial presence for LG Chem and expanding LG Chem’s global oncology portfolio. AVEO continues to commercialize FOTIVDA® (tivozanib) in the U.S. To learn more about FOTIVDA efficacy, safety, and relevant resources, visit


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