Jon Hildreth Email & Phone Number

South San Francisco, California, Us

Program Manager for GMP and non-GMP IT Systems, supporting laboratory scientists, manufacturing engineers, legal, quality, and project management.● Established and managed $20M+ IT program and project management solution required to deliver three vendor-facilitated 𝗘𝗟𝗡 implementations across more than 12 global business functional pillars.● Kept program sponsors, steering committee, and internal & external stakeholders informed on roadmap milestones, project risks & issues, and status updates by providing cross-functional leadership and driving a customized and flexible communication strategy. ● Developed metrics to evaluate progress across development milestones as well as target post-production KPIs on utilization and adoption.● Assessed and overhauled enablement scrum team health and roles, ceremonies, use of tools, and training to deliver 20 successful 2-week sprints (Scrum Master).● Saved over $1M in initial payments and $100K in annual maintenance fees by partnering with manufacturing and procurement to craft right-sized global software contracts with a vendor’s CEO.● Product Owner of a molecule registration integration database, providing 200+ scientists access to firewalled intellectual property.

South San Francisco, California, Us

Provided IT Quality and IT systems delivery expertise on critical and enterprise efforts requiring high compliance with external regulations, internal policies, and industry best practices. ● Increased qualification compliance by 1000%+ and saved over $10M+ by creating an enterprise gamified CSV Training Program adopted globally by 10K+ users within two years.● Established an IT Quality function (CSV, IT Risk Management) in APAC to support local business teams of over 500 employees by hiring and training resources in Shanghai, Indonesia, and the Philippines.● Spearheaded the development, validation, and delivery of a global information risk management platform (50K users) through several system life cycles (paper/excel to a hybrid web portal to a cloud Business Process Management platform).● Designed and orchestrated the Master Validation approach for M&A, including an $8B acquisition.● Defined, collaborated, and mapped Roche Global IT Processes.● Author/Contributor Global CSV governance: Policy, Directives, SOPs● Steered teams to compliance by providing Quality oversight: ✅ adverse event reporting system development and operations ✅ process and change management for Trackwise QMS ✅ GxP agile testing methodology development ✅ CSV process audits ✅ APAC managed access program system development ✅ enterprise BPM platform governance and management ✅ laboratory systems used in research and early development ✅ validation of test automation tools ✅ retrospective validations of EU CRMs ✅ SAP mobile devices validation strategy ✅ HCP spend reporting systems development ✅ anti-counterfeiting systems development ✅ distribution (GDP) requirements for sample management logistics vendor ✅ secure data transfers between external partners ✅ server 2008 decommissioning, upgrades ❗️ etc.

South San Francisco, California, Us

Restructured and led the Software Quality Assurance (SQA) Program, supporting projects within the Marketing and Medical Affairs areas.● Refocused development teams on basic SDLC best practices and QA methodology resulting in 33+ successful production releases. ● Managed 5+ product teams of QA and Development resources (onsite and offshore) to deliver across multiple business groups and global regions, including the US, India, Poland, and Switzerland.● Led execution for portfolio strategy, scope, sizing, resourcing, road mapping, budgets, and executive stakeholder partnerships.

Red Bank, New Jersey, Us

Enabled a small pharma company to implement a new LIMS system by setting up the project structure and aligning resources between the vendor, the client, and professional services.

San Francisco, California, Us

Managed end-to-end development and batch testing teams of 20+ (billing, claims, payment processing, and documents) on the Enterprise Streamline Project (new financial and administration platform converting multiple disparate state and local systems into one).

New York, Ny, Us

Managed diverse development teams onshore and offshore of up to 11 people, with a broad portfolio supporting Private Client Services, Private Banking Technology, and Global Technology Infrastructure.

Westlake, Texas, Us

Responsible for quality assurance and testing strategy for enhancements, infrastructure changes, and bug fixes implemented on the largest secure website of the time (schwabinstitutional.com). Onsite and offshore management of QA resources for testing, application checkouts, installation verifications, and knowledge transfer.