Geneva Cooper
5.0
(9)
Studied at Fitchburg State College
Hiring Manager at Ultragenyx Pharmaceutical Inc
Successful clients at
Not currently taking new clients
Work Experience
Associate Director, Quality Systems Management
Ultragenyx Pharmaceutical Inc
September 2021 - Present
Hiring Manager
• Lead cross-functional processes and teams within Quality, Manufacturing, Regulatory, Pharmaceutical Development, and other divisions, driving collaboration and effective implementation of key projects for CMC (Chemistry, Manufacturing, and Controls) initiatives. • Spearhead the supplier quality Community of Practice (CoP) to identify and implement industry best practices, which yielded improved processes and 60% increase in compliance in 2 years. • Develop executive-level communications and presentations in conjunction with senior leaders to convey value proposition of quality initiatives and reinforce alignment across all stakeholders. • Implemented collaborative forums to improve operational efficiency across Quality and Technical Operations. • Established and managed external relationships, contributing to business development, growth, and impact. • Surpassed annual targets for the company-wide DEIB transformation, earning the “UltraRare” and “Rare Pearl” Awards for excellence in DEIB strategic planning, facilitation, and overall program ratings. • Enhanced the Supplier Quality Management program strategy, resulting in a 20% increase in performance. Diversity, Equity, Inclusion and Belonging (DEIB), Strategic Communications and +13 skills
Quality Assurance Manager
Ultragenyx Pharmaceutical Inc
March 2019 - September 2021
Hiring Manager
• Integrated and implemented global quality training program for east coast operations, including curricula design, establishment team of area training leads, and creation of metrics program. • Provided strategic guidance and leadership to Pharmaceutical Development organization, resulting in the adoption of the global quality electronic document management system (EDMS) for reporting and knowledge management • Managed critical stakeholder and vendor contracts, fostering strong relationships through proactive communication & seamless business continuity – e.g., risk assessment, audit, generation, and oversight. • Earned the “UltraRare” Award for facilitation of the first company-wide Inclusion & Diversity Summit and excellence in quality management portfolio. Business Strategy, Diversity, Equity, Inclusion and Belonging (DEIB) and +14 skills
Executive Leadership Coach
Goal Coaching Associates
June 2018 - Present
• Thought-partner and guide leaders in implementing organizational strategies that proactively mitigate risks and maximize performance. • Designed a comprehensive development framework for feedback and growth mindset, which reduced turnover and led to marked increase in employee satisfaction scores across management. • Create and facilitate transformational programs to increase confidence, strengthen execution skills, yielding noted improvements overall satisfaction and amplified engagement. • Redesigned and facilitated a comprehensive organizational strategy and development framework for feedback and growth mindset, subsequently reducing turnover and marked increase in employee satisfaction scores with management. • Facilitate ideation and planning for executive communication and workforce planning, in topics ranging from change management, employee experience, customer retention, and R&D. Diversity, Equity, Inclusion and Belonging (DEIB), Strategic Communications and +12 skills
Quality Assurance Manager
EyePoint Pharmaceuticals
May 2018 - December 2018
• Formulated Quality Management System training, SOPs, and monitoring procedures; managed release testing activities; and authored quality reports for investigations, stability protocols, and documentation disposition. • Championed continuous improvement by coaching and empowering staff in an inclusive, supportive environment where diverse perspectives are valued and contribute to collective progress. • Initiated and led a series of workshops and team events focused on promoting cultural awareness and inclusivity, resulting in a 45% increase in collaboration among staff. • Managed cross-functional efforts with support functions including HR, Finance, and IT, ensuring effective collaboration and alignment. • Implemented new IT systems, improving operational efficiency by 20%. Strategic Communications, Organizational Leadership and +10 skills
Quality Control Supervisor
Biogen
October 2007 - June 2017
Hiring Manager
• Managed a team of 8 with responsibility for in-process release and viral clearance testing. • Established an in-vitro test method that reduced hands-on time by up to 50%. • Organized and facilitated team building discussions and events to promote a learning culture, understanding, and collaboration resulting in increased engagement and 50% reduction in deviations and non-conformances. • Instituted and implemented laboratory recycling program with Environmental Health and Safety (EH+S) organization. Strategic Communications, Biotechnology Industry and +9 skills
Education
Fitchburg State College
Master of Business Administration - MBA, Human Resources Management and Services
2018 - 2019
Boston University Questrom School of Business
Bachelor's degree, Biomedical Laboratory and Clinical Science
Teamwork and Interpersonal Skills
9 Reviews
Overall Rating
5.0
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