Brett Ouimette

About Brett Ouimette

My attention to detail is exceptional, and I am passionate about collaborating on process development opportunities and fostering cross-functional teamwork. I am adept at adapting to new environments and possess a strong proficiency in emerging technologies. I have been worked across academic, clinical, and industry research environments for over 10 years in multiple therapeutic areas, including but not limited to: Oncology (Phase 1 Clinical Trials & Pediatrics), Neurology, Bone / Osteoporosis, Hematology, Nephrology, and bio-psycho-social research. Additionally, I have experience working with regulatory submissions in multiple global regions and within R&D Quality.At the core of my professional philosophy lies a commitment to maintaining transparency, ethical conduct, and a positive outlook in all aspects of my work. I excel at collaborating effectively within intricate cross-functional teams and organizations, drawing upon my diverse skill set, particularly my expertise in social and cognitive psychology. This knowledge enables me to guide my thought process and foster innovative solutions, emphasizing inclusivity in the workplace. Additionally, I prioritize building robust and positive relationships with internal and external stakeholders. I firmly believe that adopting this fundamental approach to creating a collaborative and positive working environment with regulators, coupled with a patient-centric mindset, is pivotal in expediting regulatory approvals for rare diseases globally.Disclaimer: The opinions, comments, and views posted on this website are solely my own and do not necessarily reflect those of the companies,organizations, or affiliates I am associated with.

Experience

1. Senior Manager R & d Quality Operations & Excellence

   BeOne Medicines

   Feb 2025 — Present

   Support integration of QbD principles throughout R&D processes to ensure proactive quality assurance while collaborating with cross-functional teams to design and refine processes that align with internal standards, minimize risks, and reflect the latest industry and regulatory requirements- Support the process impact assessment process, reviewing new and revised SOPs prior to authoring to assess their impact, risk, alignment with industry trends, and GXP requirements- Support internal SOP Committee focused on providing support to cross functional teams to review new controlled procedures or procedures requiring substantial cross functional feedback- Develop and maintain systems for tracking issues, deviations, CAPAs, and quality events across processes, protocols, and procedures and analyze trends to identify potential systematic - Lead root cause analysis for quality events and implement preventive measures to improve process robustness and reduce future risks- Manage and lead the quality review process for SOPs and other controlled documents before release, ensuring alignment with regulatory and internal standards- Collaborate with document owners to ensure that procedures are both practical and compliant, facilitating easier implementation across teams- Lead continuous improvement initiatives by identifying opportunities for process optimization, balancing quality control with operational efficiency- Participate in the review of study related metrics (i.e; protocol deviation, etc.) as part of the Quality Management Risk (QMR) approach to identify gaps, trends, and the need for process improvements- Manage/review trends and report significant investigation/deviation issues and system deficiencies to senior management, as appropriate- Partner with business representatives to assess processes, procedures, and protocols to identify impacts, risks, and interdependencies to build quality into BeiGene R&D Operations.

Education

• Santa Barbara City College

  Associate's degree, Psychology

  2008 — 2010

• The High School at Moorpark College

  High School Diploma, College/University Preparatory and Advanced High School/Secondary Diploma Program

  2006 — 2008

• UC Santa Barbara

  Bachelor of Arts (BA), Psychology

  2010 — 2012

• Royal High School

  Transfer, High School

  2004 — 2006

• Moorpark College

  Transfer, Psychology

  2006 — 2008

Skills

• Irb Protocoles
• Budgets
• Data Analysis
• Employee Training
• Informed Consent
• World Views and Perceptions
• Microsoft Office
• Lab Management
• Presentations
• Experimental Therapeutics Oncology
• Study Design
• Analysis
• Time Management
• Physiological Data Analysis
• Leadership
• Grant Writing
• Psychology
• Laboratory
• Research
• Quantitative Research
• Technology
• Project Management
• Institutional Review Board (Irb)
• Gender Equality
• Technology Proficiency
• Project Coordination
• Data Coding
• Cultural Awareness
• Spss
• Literature Reviews
• Customer Service
• Learning Quickly
• Laboratory Skills
• Qualitative Research
• Critical Thinking
• Cancer Research
• Irb Applications
• Higher Education
• Virtual Reality
• Budget Coordination