Sr. Quality Specialist - IS Validation (08-1-2041-01B)

Sr. Quality Specialist - IS Validation (08-1-2041-01B) Department/Division: Quality Assurance/Safety Job Type: Full Time, Employee Company: Vertex Pharmaceuticals Inc. Location: US-MA-Boston Job Reference Id: 1212   Description: Posting Title: Sr. Quality Specialist - IS Validation Department /Division: Core Quality Classification: Quality Assurance Job Type: Full-time, exempt Location: Cambridge, MA Required Travel: No Required Education: B.S. Relocation:Yes Job Description Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, inflammation, autoimmune diseases, cancer, pain and bacterial infection. Position Overview: This position will be a senior contributor to the IS Quality/Validation function within the Quality Alliance group. This position will provide day-to-day support of the IS Quality/Validation function with a high degree of independence, and will play a key role on system implementation projects. Emphasis is on quality management, Infrastructure, and supply chain (ERP) systems. Key Responsibilities: The individual will serve as an IS Quality/Validation subject matter expert (SME) and provide guidance on validation and testing strategies for each implementation project based on system risk, complexity, and other relevant factors. This includes, but is not limited to: * Represent IS Quality/Validation on projects; and management teams as appropriate * Ability to work independently on validation strategies for system implementations and changes to ensure solutions are demonstrated as fit for purpose * Partner with the Vertex system implementation teams to ensure Part 11 compliance * Provide consultation and support as required to meet project goals and objectives. * Perform Quality review and sign-off of computer system control documents * Review requirements packages and provide compliance & quality inputs to the requirements engineering process * Manage multiple simultaneous validation, revalidation, and change control activities. * Review and approve validation and test protocols for adequacy and completeness. * Independently solve Validation related problems and implement corrective actions as needed * Work to maintain the validated state of Vertex computer systems by participating in the change control process * Maintain validation related metrics and reports performance to management * Participate in and/or support regulatory inspections as assigned * Participate in and/or support software vendor audits as assigned * Perform other duties as assigned Minimal Requirements B.S. (or equivalent degree) and 4 – 6 years of relevant work experience as well as a practical working knowledge of validation, quality assurance, information systems, and risk management best practices. Knowledge of GCP, GLP, cGMP, HIPPA regulations is required with an emphasis on 21CFR Part 11. Excellent communication, interpersonal skills, and customer focus are also essential. * At least 4 years of direct experience writing and executing validation documentation required * Project management experience in the pharmaceutical/biopharmaceutical industry preferred * Experience with validating electronic records management, quality, and supply chain (ERP) systems preferred * Experience with System Life Cycle models required * Must be able to demonstrate good communication skills both oral and written * Must be able to demonstrate excellent customer service skills * Must have demonstrable flexible & out of the box thinking approach to problem solving and process improvement * Must be well organized and willing to work as part of a team * Test automation experience a plus * Knowledge of the application of ITIL good practices for IT Service Management preferred Apply Now