Silas Thomas
Phoenixville,PA
Summary
Dedicated Compliance professional with history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.
Overview
11
11
years of professional experience
Work History
Global
Glaxo Smith Kline
09.2019 - Current
- Ethics & Compliance
- Successfully work with all levels of leadership to ensure that the right products reach the right patient in the right way
- Partner with Business Leaders in the development and execution of annual operational business plans in coordination with matrix stakeholders to build robust risk management plans
- Provide risk mitigation support to US Pharma Organization through effective Business Partnering
- Led the Implementation of a centralized system to review and approve all US funding requests across Medical, and Commercial (Grants, Sponsorships and Memberships)
- Collaborate with sales and marketing leaders in the identification of improvement opportunities to build fit-for -purpose solutions to continuously improve ways of working for field sales personnel
- Establishing an Enterprise Framework for onboarding large groups of employees as a result of M&A activities to improve new employee experience and improve trust
- Demonstrates leadership ability to work in a matrix environment with all levels of leaders
- Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigor and risk to improve risk management
Assistant University Compliance Officer
Villanova University
11.2015 - 06.2019
- Promoted a culture of ethics and compliance across the university
- Monitored the effectiveness of the university ethics and compliance program on a continuing basis, taking proactive steps to improve its effectiveness
- Coordinated and responded to inquiries and audits by regulatory agencies
- Provided oversight and guidance to compliance partners embedded in various departments, such as research, human resources, EHS and finance
- Managed the maintenance and maturity of the university ethics and compliance program and incorporated best practices for risk management
- Minimize enterprise risk by partnering with key stakeholders to identifying risks, seek improvement opportunities, developed risk mitigation plans, and enhanced internal controls
- Collaborate with Enterprise Risk Management team to identify and address high risk compliance areas
- Developed collaborative relationships and establish regular communications with departments that had operational compliance responsibilities across the organization
- Worked with risk owners to ensure departments have compliance plans that include adequate controls, creation/revision of policies and procedures, conducting effective training and education, and conducting internal monitoring
- Collaborated with and provide guidance to the University Compliance Committee and its subcommittees
- Participated in interactions with external business partners and regulatory agencies to ensure adherence to changing regulatory requirements
- Coordinated enterprise-wide compliance training needs with compliance partners to help ensure that departments owned the compliance responsibilities relevant to operational business risks
- Developed an effective monitoring framework to ensure that policies, procedures and processes was updated in accordance with changing laws and regulations
Global Ethics and Compliance Manager
Shire Pharmaceuticals
04.2013 - 11.2015
- Assisted in the development of global compliance and ethics program to ensure compliance with laws and regulations affecting global engagements
- Participated in risk assessments to evaluate compliance readiness and developed controls to address any gap that were identified in collaboration with risk owners
- Developed policies and procedures to enhance/encourage a strong ethical culture with global business units in response to changing laws, regulations and business needs
- Identified risks and established systems and controls associated with engagements with global Healthcare Providers (HCPs)
- Managed the implementation of a global HCP engagement tool to manage and monitor HCP activities
- Co-chair of committee that developed and implemented Fair Market Value guidelines to effectively establish limits and monitor paid engagements
- Collaborate with US and Global Compliance partners in ensuring that compliance goals are met and maintained in high risk countries
- Oversee HCP background screening process investigated issues relating to FDA, OIG, and internal regulatory issues
- Assist with developing communications in support of training needs of functional areas supported by Global Compliance
Compliance Specialist
Globus Medical
Audubon, PA
11.2011 - 04.2013
- Worked with cross functional teams to plan, formulate and implement new and improved internal controls for continuous improvement and risk mitigation
- Represented Compliance/QA at departmental meetings and on cross-functional committees/teams, external partners and manage service providers
- Provided monitoring of product complaints and MDR investigation process to ensure effective corrective and preventive actions are taken and implemented
- Conducts review and revising of Quality Manual/Procedures, Corrective and Preventive Actions (CAPA), Deviation Management Complaint Handling, Supplier Quality Program, Document/Records Management
- Reviewed regulatory compliance documentation for changes affecting device manufacturing in global markets including 510k, PMA, IDE, ISO, labeling, CFR standards and regulations
Quality Assurance Specialist
Wuxi Apptec
Philadelphia, PA
12.2010 - 11.2011
- Assists in the management of overall quality, compliance, and auditing activities to ensure compliance with the organization’s policies and standards, Food & Drug Administration (FDA), Code of Federal Regulations (CFR) by conducting audits of internal processes, clinical sites, and suppliers
- Review product and process non-conformance and recommend remedial actions including but not limited to modifications of processes, products or QA standards where warranted
- Compiles and reviews raw data, batch records and test results including final reports in accordance with cGMP, good laboratory practices (GLP), points to consider (PTC), good documentation practices and code of federal regulations (CFR) guidelines
- Maintaining corrective and preventative action activities to ensure that potential problems and root causes for deviations and investigations are identified, impact assessed and actions to prevent recurrence are implemented
Education
Master of Jurisprudence Degree - Health Law
Widener University School of Law
Bachelor of Science Degree - undefined
Cairn University
Skills
- Global Compliance
- Regulatory Compliance
- Auditing and Reporting
- Enterprise Risk Management
- Data Governance
- Change Management
- Continuous Improvement
- Policy Management
Timeline
Global
Glaxo Smith Kline
09.2019 - Current
Assistant University Compliance Officer
Villanova University
11.2015 - 06.2019
Global Ethics and Compliance Manager
Shire Pharmaceuticals
04.2013 - 11.2015
Compliance Specialist
Globus Medical
11.2011 - 04.2013
Quality Assurance Specialist
Wuxi Apptec
12.2010 - 11.2011
Master of Jurisprudence Degree - Health Law
Widener University School of Law
Bachelor of Science Degree - undefined
Cairn University