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 certification, underscoring our unwavering commitment to data security and regulatory compliance. This initiative aligned our practices with international standards and fortified trust with our global clientele.𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗰 𝗟𝗲𝗮𝗱𝗲𝗿𝘀𝗵𝗶𝗽 𝗶𝗻 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗦𝘆𝘀𝘁𝗲𝗺𝘀 (𝗤𝗠𝗦): I direct the development and ongoing enhancement of our QMS, integrating cutting-edge methodologies to boost efficiency, reliability, and adherence to compliance standards. My strategic oversight is instrumental in refining our product quality, operational excellence, and continuous improvement. 𝗦𝗼𝗳𝘁𝘄𝗮𝗿𝗲 𝗩𝗮𝗹𝗶𝗱𝗮𝘁𝗶𝗼𝗻 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆 𝗮𝗻𝗱 𝗘𝘅𝗲𝗰𝘂𝘁𝗶𝗼𝗻: My leadership includes managing our software testing and validation framework, employing contemporary guidelines such as Risk, CSA, GAMP 5, and critical thinking. I oversee the strategies, processes, and tools that underpin our robust validation efforts, ensuring our software meets out clients' rigorous requirements.𝗖𝗿𝗼𝘀𝘀-𝗳𝘂𝗻𝗰𝘁𝗶𝗼𝗻𝗮𝗹 𝗧𝗲𝗮𝗺 𝗟𝗲𝗮𝗱𝗲𝗿𝘀𝗵𝗶𝗽: I foster a culture of quality and compliance throughout our organization. By adapting our approach as we scale, I ensure that quality and regulatory compliance are embedded in every facet of our operations and the lifecycle of our critical products.As CellPort continues to expand and innovate, my role is pivotal, maintaining the highest standards of quality and compliance, ensuring that we meet and exceed the rigorous demands of the life sciences sector.

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 industry.𝗪𝗵𝗮𝘁 𝗪𝗲 𝗢𝗳𝗳𝗲𝗿: 🛠️𝗡𝗮𝘃𝗶𝗴𝗮𝘁𝗶𝗻𝗴 𝗧𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝗶𝗰𝗮𝗹 𝗮𝗻𝗱 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗟𝗮𝗻𝗱𝘀𝗰𝗮𝗽𝗲 🧭: Expertise in managing critical stakeholder interactions ensures effective system assessment, selection, implementation, validation, and maintenance. 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗔𝘀𝘀𝘂𝗿𝗮𝗻𝗰𝗲 𝗮𝗻𝗱 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 🎯: I implement robust quality management systems that enhance compliance and operational efficiency. My strategic insights help ensure that all processes adhere to the highest standards, fulfill regulatory requirements, and exceed quality benchmarks.𝗖𝘂𝘀𝘁𝗼𝗺𝗶𝘇𝗲𝗱 𝗦𝗼𝗳𝘁𝘄𝗮𝗿𝗲 𝗦𝗼𝗹𝘂𝘁𝗶𝗼𝗻𝘀 💻: Drawing on a foundation in technology, I manage software development of solutions that solve your problems. These tools are built ground-up to strengthen your validation position and ensure operational success.𝗘𝘅𝗽𝗲𝗿𝘁 𝗦𝗲𝗿𝘃𝗶𝗰𝗲𝘀 🌐: My extensive network of industry professionals allows me to extend our service offerings, providing clients with innovative solutions and specialized expertise tailored to their needs.𝗪𝗵𝘆 𝗖𝗵𝗼𝗼𝘀𝗲 𝗗𝗿𝗶𝗳𝘁𝗽𝗶𝗻? 💡Driftpin Consulting's critical ability to translate complex technical and regulatory requirements into clear, actionable strategies sets Us apart. We are committed to transforming your challenges into opportunities for growth and success. 𝗖𝗼𝗻𝗻𝗲𝗰𝘁 𝗮𝗻𝗱 𝗖𝗼𝗹𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗲 🤝Interested in how we can solve your challenges? Reach out here on LinkedIn, call +1 610-772-5726 or visit www.driftpin.com. Let's collaborate to achieve your goals

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 dashboards, and KPI tracking.

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, helping clients optimize time-to-market and minimize software development risks in mission-critical areas. With an unrivaled talent pool of highly skilled software engineers and industry experts in New York, London, Switzerland, Germany, Poland, Argentina, and Ukraine, DataArt provides the technical skill, accountability and industry knowledge needed to deliver regulatory compliant applications on time and on budget.Areas of Expertise: Drug Discovery Systems, Pre-Clinical, Clinical Trials, ePRO, eConsent, EDC, CTMS, Wearables, mHealth, Pharma Sales & Marketing, EHR, Practice Management, Patient Portals, Payer Systems, mHealth, TeleHealth, & more.

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, specifically in Risk-based Monitoring, digital health, and imaging clinical trial support; delineate services, analyze revenue and market potential, resource planning, and external messagingGlobal Sales Lead for multi-national accounts, responsible for new business development, relationship management, process improvement, operational integrity, quality management oversightSupport Sales and Marketing efforts in the clinical services sector by providing expertise in the alignment of clinical trial business requirements, operational process, and technology appropriate for those needsManage consultants with expertise in clinical development, clinical operations, clinical data management, quality management, computer system validation, and system implementation

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 Clinical – Siebel Clinical integration PIP, develop go-to-market plan involving sales, marketing, and client cultivation to ensure project success and to realize ROICreated unique value propositions through alignment with Compliance and QMS practices; crafting innovative, risk-based approaches for hosted SaaS implementationsManaged a team of consultants with expertise in clinical development, clinical operations, clinical data management, quality management, business process management, computer system validation, and system implementationInitiated and grew strategic partnerships, driving success by focusing on operational workflow analysis, delineation of core business requirements, and delivery of best-in-breed services

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 success through establishing unambiguous client expectations and meeting or exceeding all deliverable commitments; this approach resulted in substantial improvements in client satisfaction and staff retentionManaged interactions between internal business owners and IT; ensured consistency between requirements and design; focus collaborative efforts to continually enhance Key Performance Indicators; initiated/justified early-phase propositions with ROI and TCO analyses; established mechanisms for change control managementInitiated and oversaw the creation of procedures that codified RECIST and Choi tumor response assessment criteria, which enhanced data quality and optimized radiologist reading sessionsEnhanced strategic relationships with major sponsor/clients through outward facing role as leader of data management and clinical technology operations; rebuilt and improved customer confidence by driving quality improvements and focusing on proactive collaboration and communication with key personnel at each sponsorManaged the new installation, implementation and integration of Oracle Clinical and RDC (v. 4.5.1) to replace an existing in-house DE system; oversee the process of migrating ~40 pre-existing studies into OC database, including drafting of requirements, specifications, and project plan. Maintain compliance w/ GCP, FDA & ICH regulations (sp. 21CFR11). Manage the implementation of RDC 4.5.1 and 4.5.2.

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 of product launch processes and go-to-market strategiesParticipated in the development of UI Tests, collection and analysis of results, and formulation of design change proposalsNegotiated with internal groups to create new interface designs that satisfy user needs, technical specifications, and resource availability

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 companies like Shell Offshore and ABB, showcasing adaptability and ability to deliver in highly technical and regulated environments.Impact: Refined skills in managing complex stakeholder relationships, aligning communication with business needs—key to building my current life sciences consultancy.

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 sciences compliance and validation.*Impact: Strengthened my ability to translate complex technical findings into actionable insights, a skill I leverage today in regulatory and software validation projects.*

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 situations, driving consistent, reliable outcomes in dynamic and hazardous settings.Led cross-functional teams to deliver mission-critical operations with strict adherence to safety, quality, and performance standards.Impact: Developed a disciplined, results-oriented approach to problem-solving and leadership, which continues to inform my ability to manage complex projects and meet critical deadlines.

Education record

Altmba, Ruckus