Stephen Weil Email & Phone Number

Norwalk, Connecticut, Us

• Advised clients on continuous improvement of Computer System Validation and SDLC processes to ensure compliance with regulations.• Led the development of CSV documentation and testing of computer systems at DataCompliance LLC.• Ensured software was fit for intended purpose by evaluating and documenting policies/procedures.

Burlington, Ma, Us

• Implemented a GxP data management program & instituted best practices in the SDLC. Employed KPIs to track progress along the compliance roadmap. This was evidenced by a 25% decrease in reported deviations during SDLC within a year.• Revised the current e-compliance and data governance policies and practices within the QMS. The process lowered the number of risks that were found.• Developed an automated risk-based template that measured application’s amount of validation required. The scoring replaced “gut feel” for deciding on the amount of validation required.• Created a process that reviewed all data from creation to archive. Uncovered critical GxP risks that could have led to agency observations or worse. Data was being held in non-compliant systems & lacked a archive system. Added an archive system. Negotiated new quality agreements (QA) with customers. The result was a 55% reduction in the loss of data held within the systems. All data (paper & digital) were retained forever which is a critical data integrity risk as well as a financial one. Enacted a destruction program & held data for seven years. • Created an enhanced data integrity training program.Upgraded the QMS & added functionality which reduced human error.• Uncovered unvalidated spreadsheets that were used for calculations of Bioassays. Initiated project to validated all spreadsheets.• Ensured that the organization followed regulations such as the FDA, MHRA, EMA, ITIL, ICH & ISO 9001:2015 which reduced regulatory observations.• Validated an innovative cloud platform that other applications could use. Preset all calculations to perform Next Gen Sequencing with a single action. Created an application for a hospital to follow Covid patients at home and able to interface with their HCP.• Managed team that was responsible for the QMS and approved final GxP documentation, team served as admin for applications & equipment.• Member of regulatory inspection team and responded to their queries.

Fishers, Indiana, Us

• Contracted to be the Quality lead for a mid-size company, overseeing ongoing compliance of validated systems & ensuring the adequacy of the firm’s QMS. • Managed final approval of all GxP documents to maintain compliance. • Final approver on all GxP documents to ensure compliance.• Employed Veeva as the EDMS and QMS. Used Veeva for all change management activities. • Collaborated with cross-functional teams to provide guidance on compliance, data integrity, HIPAA & data privacy.

Cambridge, Cambridgeshire, Gb

• Hired and trained high performing team to be quality representative on all GxP projects. Controlled headcount budgets and provided training. Reviewed team members performance.• Maintained a record of zero quality observations with the regulatory agencies for 5 straight years. • Decision maker of all global regulatory standards for GxP operations. • Implemented Agile & Lean methodologies which streamlined software development process. Resulted in a 20% reduction in development time & a 25% increase in efficiency. Agile provide system owners with a continuous view of the SDLC status.• Contributed to operational planning, & budgetary processes to ensure sufficient investments were allocated for execution. • Updated the risk-based template for amount of validation required. The automatic scoring replaced the “gut feel”.• Collaborated with Cybersecurity team to ensure process aligned with physical security program.• Interfaced with customers to understand their needs & to strengthen relationships. Built trust & respect with customers & negotiated quality agreements.• Created a continuous improvement program & implemented best practices for GxP data quality. Employed KPIs to track progress & employed timely fixes as required. Provided senior management with periodic updates.• Responsible for ensuring system owners conducted periodic reviews.• Worked with Data Privacy office to train to my team to provide knowledge of GDPR, GAMP & HIPAA. • Conducted yearly testing of business continuity, backup & restore and disaster recovery programs.• Hosted FDA inspections and responded to global quality questions.• Ensured all vendor audits were conducted using single global process.• Performed internal audits periodically to ensure continued compliance.• Maintained compliance with all applicable regulations. The FDA, Annex 11, EU, MHRA, ITIL, ICH and ISO 2015 (QMS) • Quality lead for medical device applications, such as SaMD, & innovative SAAS solutions.

• Provide QA strategies and best practices, including test plans, test cases, documentation for manual and automated testing.• Supervised and performed validation activities in collaboration with system & process owners worldwide. • Provided direction and developed training to cross-functional teams regarding regulatory risks across the software development life cycle. Effort reduced development time and rework by 18% over previous year.• Installed an upgraded change management system which connected the CAPAs, root cause process and validation process. • Employing risk-based assessments I ensured that systems adhered appropriately to all SOPs & relevant SOPs found in the QMS. • Instituted an initiative to optimize regulatory efficiency across processes, personnel, & technology implementations. • Supervised inquiries from inspectors pertaining to global systems during regulatory audits. • For ConvaTec, a medical device company, I Conducted an on-site visit to audit the new data center. Qualified the new servers and moved all the applications and data from the host company’s servers to new servers Successfully concluded the project within budget & on time. • Worked with global application teams and represented IT Quality & data lifecycle on agency inspections of the processes and all relevant documentation.• Upgraded and installed a risk-based Program that provided a more granular measurement of risk and automated the process to lessen human error.

Basking Ridge, Nj, Us

Dedicated to fostering collaboration among stakeholders across various business units to integrate their requirements into a cohesive strategy. Facilitated structured client meetings to drive tangible outcomes. Led validation efforts for diverse companies, crafting SOPs, and overseeing CAPAs and deviations. Championed good documentation practices and initiated a global vendor audit initiative. Conducted comprehensive lifecycle audits to safeguard data integrity. Introduced change management protocols and lean methodologies to enhance efficiency and minimize errors. Utilized a risk-centric approach to system classification and conducted regular risk assessments. Supervised project execution, ensuring adherence to schedules and budgets. Conducted compliance audits of data centers and liaised with external vendors to ensure regulatory compliance. Upheld rigorous standards for vendor audits and training programs. Updated QMS to reflect contemporary industry practices.