Kevin Shea Email & Phone Number

Warminster, PA, US

Exton, PA, US

As the fractional Head of Quality at CellPort Software, a pioneering life sciences software company, I spearhead our Quality, Information Security, and Regulatory Compliance divisions. Here’s a highlight of my core responsibilities and achievements:𝗘𝘅𝗽𝗲𝗿𝘁𝗶𝘀𝗲 𝗶𝗻 𝗜𝗦𝗢 𝗖𝗲𝗿𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲: I successfully led our drive to achieve ISO 27001.

Doylestown, PA, US

🌟 𝗪𝗲𝗹𝗰𝗼𝗺𝗲 𝘁𝗼 𝗗𝗿𝗶𝗳𝘁𝗽𝗶𝗻 𝗖𝗼𝗻𝘀𝘂𝗹𝘁𝗶𝗻𝗴 🌐At Driftpin Consulting, I specialize in navigating the complexities of technology and regulatory compliance within the life sciences. Leveraging my experience in software development, data management, and clinical technology, I provide strategic, comprehensive solutions that address the unique challenges of this dynamic.

Princeton, NJ, US

Manage the development, validation/compliance, and project management for new client implementations of Soterius’s vmsl (Virtual MSL) platform. vmsl facilitates efficient, compliant, and high-quality communications and scientific information exchange between HCPs and Medical Science Liaisons. It also provides full operational metrics reporting, management.

New York, NY, US

DataArt (www.dataart.com) is a mid-size technology consultancy and bespoke software development firm that combines deep domain expertise in highly regulated industries like life sciences, healthcare, and finance, with the cost advantages and resource flexibility of offshore, near shore, and onshore development. We create industry-defining applications.

Noida, Uttar Pradesh, IN

Manage and grow a clinical technology practice specializing in solutions for SMB clients, incorporating business process services that improve the efficiency and quality of clinical trials for sponsors and site usersIdentify and develop business plans/justification for strategic initiatives that extend company’s solution set and increase client value.

Paris La Défense, France, FR

Drove eClinical business practice specializing in solutions for Life Science applications leveraging Data Center hosting and Managed Services implementations for the Oracle Life Sciences Application setManaged and grew the relationship with the Oracle Health Sciences Global Business UnitProvided leadership of external partner team delivering the Oracle.

Conceptualized and led the initiation of the Clinical Technology department, which resulted workflow efficiencies, increased sponsor satisfaction, reduced audit-risk, and significantly enhanced data quality across the clinical data management and technology groupsProvided leadership through clear communications at the team and individual levels, achieving.

Austin, Texas, US

Pharmaceutical/Clinical Research Applications group, which produces Oracle Clinical, RDC, TMS, Oracle AERS, Oracle LSH. Managed the development of technical documentation such as Release Notes, Installation Procedures/Requirements, Functional Design, and Technical Design specificationsMember of the OC/RDC/TMS development team, contributed to the creation.

Delivered document-focused solutions (e.g., web sites, online help systems, API manuals, procedural guides) to clients across technology, engineering, and scientific industries.Provided comprehensive document management services, emphasizing usability and regulatory alignment, improving end-user engagement and retention.Clients included Fortune 500.

Washington, DC, US

- Conducted detailed technical research and authored peer-reviewed scientific articles, developing a precision-driven approach to problem-solving and technical writing.- Collaborated with cross-disciplinary teams to implement advanced instrumentation and research methodologies, demonstrating a systems-focused mindset that informs my current work in life.

Executed high-risk underwater construction and structural repair projects requiring precision, logical problem-solving, and rapid decision-making in life-critical environments.Applied systems-based thinking to solve complex challenges under extreme conditions, ensuring operational success and safety.Maintained focus and efficiency in high-pressure.

Education record

Altmba, Ruckus