David Squirewell, Jr.
Principal Compliance Architect – Electronic Systems Validation, G1 Therapeutics
Currently the Head of IT Quality and Compliance at G1 Therapeutics. G1 Therapeutics is a pharmaceutical company focused on the mission to develop and deliver next generation therapies which improve the lives of people living with cancer.
Professional Goals: Twenty-four (24) years of Validation/Quality/Compliance leadership/consulting and executing advising experience that include the development and maintenance of the quality management systems and the governing process for the entire lifecycle of equipment, utilities, processes, facility, and software and data quality.
Relevant achievements: Proven leader, mentor, and motivational team member. Improved the IT Change Management process by implementing a new eCM system and modified the CM procedure. Successfully implemented multiple enterprise platforms including LIMS, Veeva, Oracle, Medidata. Successfully led IT focused audits and inspections (FDA, EMEA, etc.) that resulted in no critical findings. Let the implementation of the digital strategy project which included creating the data governance policy and process for data integrity compliance. Being a husband and father of two.
Hobbies: Enjoy running marathons as well as working out and spending time with my family.
Skills and area of expertise: Quality Management, Data Integrity, Computer System Validation, IT Project and Change Management, Risk Management, Test Strategy and Management, Security and Access Management, CAPA Management, Process Improvement, Data Governance
