Alex Au Email & Phone Number

San Francisco Bay Area

San Francisco Bay Area

Danville, Ca

• Full-time hospice care for a terminal family member. Volunteering at Food Bank and TapRoot staying connected.

San Francisco Bay Area

• Hired and groomed team up to 25 managers, engineers, and tester staff with the $3M budget. • Improved business systems by deploying mapping, gap analysis, and process re-engineering including Six Sigma methods to mitigate risk, ensure regulatory compliance for client companies’ data needs, including clinical operations, biometrics, and clinical data management. • Increased project productivity by 35% and business unit revenue growth of 15-20% yearly by championing the SDLC conversion from Waterfall to Agile.• Achieved a 70% efficiency gain with improved testing documentation and exhaustive regression testing through implementing in-house automation tool development for test engineers.• Consulted as Subject Matter Expertise (SME) for the Business Development Team by winning new and renewed business contracts.• Engaged with clients to better understand their expectations, business needs, operational processes and communication preferences, in order to develop client-specific standards, templates, and processes.• Member of Internal Review Board (IRB), a cross-functional group of strategic thought leaders and decision makers, overseeing process deviations, overall business challenges, and CAPA remediation.

San Francisco Bay Area

• Led and managed two functional engineering groups - Delivery and SRE group. • Hired and mentored 9-13 software engineers ensuring projects are delivered on time and utmost quality.• Provider guidance and mentorship to new engineers and project managers in developing and managing complex projects or programs.• Set performance, team expectations, and monitored/measured the team’s and individuals’ work to ensure that project commitments and targets are met.• Reducing an average number of developers needed per project by 50%, and improved delivery timeline by 2 weeks, including User Acceptance Testing (UAT) utilizing operational improvements.• Increased and maintained Production Incident resolution rates of over 15% efficiency leveraging FMEA.• Authored departmental Standard Operations Procedures (SOP) and Work Instructions (WI)• Achieved award for Exemplary Employee Performance (2013)

San Francisco Bay Area

A leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible.• Led a team of 5 Software Engineers and staff to ensure timely development and application releases. • Ensured required change control documentation was incorporated into requirements, design and other technical documents, resulting in 98% SOP and WI compliancy• Provided expertise in onboarding, group classroom as well as individual coaching in IVR/WEB technology and domain subject matter in business and technical areas. • Adhered to Good Clinical Practices (GCP), 21 CFR Part 11 and other regulatory requirements.• Engineered and upgraded internal tools utilizing more custom components and windows services.• Built numerous internal web-based tools to support business operations and needs.• Designed and developed various clinical trials with quality code, low defect count, in a fast-paced environment for randomization.

San Francisco, Ca

Novato, Ca

Wayne, Pa