Tamara Redondo
San Diego,CA
Summary
Results-driven IT and Life Science leader with extensive experience in strategic alignment and cross-functional collaboration. Seeking to leverage expertise in leading high-impact initiatives and establishing governance frameworks to enhance digital operations, streamline processes, and drive organizational growth. Committed to fostering a culture of trust and empowerment while delivering innovative solutions that align with the company’s key priorities.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Director, Digital Quality and Lab Programs
Resilience
05.2021 - Current
- IT System owner of 10+ SaaS applications
- Manage the planning, design, implementation and integration of digital system development life cycle (SDLC) as the key liaison between quality and lab teams and managed services partners
- Lead the management of the IT PMO, driving strategic alignment across all workstreams, with plans to expand governance and oversight to other IT teams and functions.
- Support 6+ acquired clinical and commercial sites through merger and acquisition process that consistently deliver projects under budget by 25% and met implementation schedules 95% of the time.
- Establish governance frameworks for digital system development, focusing on efficiency and compliance with industry standards.
- Manage and mentor a team of IT Program Managers, System Administrators and Engineers, fostering professional development and encouraging a culture of continuous learning and innovation.
Quality & Lab Systems Delivery Lead
Aji BioPharma Services
08.2019 - 05.2021
- Led development, enhancement, and integration of 3 global electronic Quality Management Systems
- Executed cost analysis of software systems, saving company $200k+/year on subscriptions
- Led implementation and development of electronic batch records and e-based solutions, calculating over $600k in ROI in 1 year
- Collaborated with internal quality groups and manufacturing laboratories to develop and maintain over 25 solutions that provide a more efficient and compliant work environment
- Led process improvement initiatives, using Lean and Six Sigma methodologies to optimize workflows and reduce operational inefficiencies by 30%
- Spearhead change management efforts across the organization, engaging stakeholders at all levels to ensure they are informed, supported, and equipped to adopt new processes and systems effectively.
Senior QA Investigations Associate
Aji BioPharma Services
03.2018 - 08.2019
- Continuously innovated by designing novel solutions, methods and workflows, ensuring seamless integration into current systems
- Drove continuous improvement by applying rigorous frameworks, fostering collaboration across teams, and strengthening partnerships to enhance stakeholder outcomes.
- Facilitated investigations related to deviations, complaints, CAPAs, and adverse events associated and improved on time closure rates from 13% to 57% in 6 months
- Supported client and regulatory audits by US FDA and foreign regulatory bodies as subject matter expert for deviation, complaint, CAPA, and QMS
Compliance Associate
Althea
05.2016 - 04.2018
- Managed and collaborated with cross-functional team members in developing recommendations for corrective actions/improvements and evaluating effectiveness of corrective actions
- Conducted internal, external and regulatory audits with clinical, commercial clients and regulatory agencies
- Collaborated cross-functionally to ensure compliance driven results were met across company
- Partnered closely with 12 functional areas to drive internal customer engagement and compliance
- Proactively studied and stayed ahead of market trends ensuring compliance risks were mitigated
Strategy and Business Operations Manager
San Diego Aviators - World Team Tennis
01.2014 - 10.2017
- Directed all aspects of game day operations, overseeing 50+ vendors, 100+ players, and 100+ staff members to ensure seamless event execution
- Collaborated with internal and external partners to build a cohesive, high-performing team environment, aligned with the organization's core values
- Led initiatives to give back to the community, partnering with local organizations and integrating corporate social responsibility into site operations
- Led cross-functional teams to develop and execute operational plans, resulting in a 35% increase in ticket sales and a 28% reduction in operational costs over three years
- Developed and executed market analysis strategies that informed operational decisions, leading to a 15% increase in market share and improved competitive positioning
- Oversaw the execution of strategic plans, aligning them with organizational goals and ensuring successful implementation across multiple departments
Education
Master of Science - Regulatory Science
Arizona State University
Phoenix, AZ2022
Bachelor of Arts - Public Health
Arizona State University
Phoenix, AZ2019
Skills
- Strategic Planning
- Agile and Scrum Methodologies
- Cloud Technologies (AWS, Azure)
- PM Tools (JIRA, Asana, Trello)
- Technical Program Management
- API Integration
- Cybersecurity Awareness
- Quality Assurance (QA) Processes
- FDA Regulatory Compliance
- People Management
- Validation Strategies (Part 11, 21 CFR)
- System Implementations (eQMS, LIMS, ERP)
Accomplishments
Veeva Hero – 2022
The Veeva Hero Award was created to recognize pioneers in their industries and organizations who have met challenges with out-of-the-box thinking and navigated the complexities of change to improve processes and outcomes in their sphere of responsibility.
Awards
Veeva Hero, 2022, The Veeva Hero Award was created to recognize pioneers in their industries and organizations who have met challenges with out-of-the-box thinking and navigated the complexities of change to improve processes and outcomes in their sphere of responsibility.
Affiliations
- ISPE International Society for Pharmaceutical Engineering
- Women in Tech
- Women in Bio
Certification
- Lean Six Sigma Green Belt (ICGB) UCSD 2019
- Kaizen Leader The Knowledge Academy 2019
- Google Project Management Google 2022
- Certified Agile Leader Scrum Alliance 2024
- Professional Scrum Master I Scrum 2024
- AWS Certified Cloud Practitioner AWS 2024
- CompTIA A+ CompTIA Expected NOV 2024
Timeline
Director, Digital Quality and Lab Programs
Resilience
05.2021 - Current
Quality & Lab Systems Delivery Lead
Aji BioPharma Services
08.2019 - 05.2021
Senior QA Investigations Associate
Aji BioPharma Services
03.2018 - 08.2019
Compliance Associate
Althea
05.2016 - 04.2018
Strategy and Business Operations Manager
San Diego Aviators - World Team Tennis
01.2014 - 10.2017
- Lean Six Sigma Green Belt (ICGB) UCSD 2019
- Kaizen Leader The Knowledge Academy 2019
- Google Project Management Google 2022
- Certified Agile Leader Scrum Alliance 2024
- Professional Scrum Master I Scrum 2024
- AWS Certified Cloud Practitioner AWS 2024
- CompTIA A+ CompTIA Expected NOV 2024
Master of Science - Regulatory Science
Arizona State University
Bachelor of Arts - Public Health
Arizona State University
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