Temp. Contract, 6 months
Vertex is seeking a Global Systems Compliance (GSC) Temp to support the group in providing oversight of the development, implementation, and maintenance of relevant computerized systems and quality initiatives. They will also support the GSC audit program, through completing GxP (GMP/GCP/GLP) audits of computerized system vendors and through managing the audit schedule and meeting with key stakeholders to ensure audits are completed in a timely manner.
-Clearly demonstrates an extensive understanding of quality and regulatory compliance as well as the application of these concepts
-Displays the ability to effectively manage client expectations
-Recognized as a technical resource within their discipline
-Determines independently the best and most appropriate methods and procedures on new assignments
-Independently solves problems of moderate complexity and scope
-Demonstrates ability to plan and execute appropriately on moderately advanced tasks and/or projects within their technical expertise
-Proven ability to lead projects and/or teams on projects of moderate complexity and scope
-Effective influencing others on project teams regarding quality or compliance concerns
-Lead audits of GxP computerized system vendors to applicable regulations and standards
-Coordinate audit planning activities with key internal stakeholders and management
-Independently provides risk management leadership on validation / SLC strategies for system implementation and changes
-Represents GSC as a subject matter expert of computer system validation principals, 21CFR Part 11 and compliance risk identification, prioritization and management at a project level
-Demonstrates basic ability to lead teams
-Demonstrates expertise in least one GXP area and basic competence in another GXP area
-Assumes a lead role as a validation expert on computer system implementation projects
-Assumes a lead role in identifying quality and compliance risks, and guides project teams in developing risk mitigating strategies
-May participate in internal cross functional process development teams
-May conduct presentations of quality issues, initiatives and projects
-May participate in a regulatory inspection or due diligence activities, as requested
-May author, review, and /or approve Policies, SOPs, Work Instructions, forms and templates
-Master of Science degree and 3 – 4 years of work experience, or
-Bachelor of Science degree in a scientific or allied health field and 8+ years of work experience
-Hands-on experience of applying electronics records and electronic signatures related GxP regulations such as FDA’s 21 CFR Part11, EMA’s Annex 11 or equivalent regulations.
-Demonstrable communication skills
-Demonstrable organizational skills
-Demonstrable problem solving and/or analytical skills
-Preferably strong MS Excel, Access, and Power Point skills
-Prior GxP auditing experience
-Solid experience of auditing technology suppliers
-Strong hands-on experience of managing and conducting technology vendors evaluations and assessments
-Experience in conducting periodic reviews of Computerized Systems including automated systems.
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist.
For more information and to view Vertex's press releases, please visit www.vrtx.com.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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