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The Manager/Sr. Manager, Quality Systems &amp; Compliance, will be integral in supporting the vendor management and audit programs for all GxP functional areas at Blueprint Medicines. Reporting to the Associate Director of Quality Systems &amp; Compliance, this individual will additionally be expected to cross-train, support, and individually contribute to the QMS and Quality infrastructure of the organization. This individual will be hands on with internal and external partners. This is an excellent opportunity to assist in the continuous growth and support of the Quality Systems and Compliance department through interaction with a variety of internal and external business partners across the GxP areas. What will be your responsibilities? \u2022 Manage the GxP Vendor and Audit programs at Blueprint medicines. \u2022 Provide business administration, management, and user support within the Veeva QualityDocs\u00a0and eQMS to GxP users. \u2022 Ensure qualifications and training for auditors is complete and documented. \u2022 Ensure vendor qualification status and documentation is maintained, archived, and updated in a timely manner through collaboration with business SMEs and development of tracking and management tools. \u2022 Collaborate and assist GxP business partners in Quality System. o Specific expertise will initially be focused in vendor records, quality agreements, audit workflows, and findings/CAPAs. \u2022 Contribute to the development of continuous improvement of Quality Systems and SOPs. \u2022 Contribute to the development of risk-based auditing schedules of CxO and internal GxP departments. \u2022 Assist and/or oversee consultant mediated audits; develop, recommend, and follow up on corrective actions with internal and external auditees, where applicable. \u2022 Assist with managing Inspections of Blueprint Medicines \u2022 Assist with establishing Quality Systems metrics and routinely reporting to senior management. \u2022 Participate in Veeva Vault process improvements projects, system configuration changes, and associated validation (UAT) activities applicable to modules used routinely (vendor/audit workflows). \u2022 Collaborate and assist GxP business partners in Quality System. What qualifications do we require? \u2022 B.S degree in life sciences, chemistry with a minimum of 10 years of experience of quality management system experience with progressive responsibility in a lead or managerial capacity. \u2022 Extensive knowledge of GxP and Quality principles, practices, and standards \u2022 Strong knowledge of global regulations (EU, US) \u2022 Excellent communication, writing and presentation skills for effectively interfacing with internal and external organizations, collaborators and customers. \u2022 Demonstrated ability to work independently and in a team environment and seek resources as necessary \u2022 Demonstrated effective time management skills \u2022 Strong professionalism and interpersonal skills \u2022 Ability to effectively prioritize and manage multiple projects and tasks. \u2022 At home in a results-driven, highly accountable environment where you can make a clear impact. \u2022 A team player, who listens effectively and invites response and discussion. \u2022 A collaborator who communicates in an open, clear, complete, timely and consistent manner. 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Duration: 6-month contract with extension as needed. Job Description: The individual will work under the guidance of the Compound Management Group to assist: \u25e6 With medchem compound submission / processing and compound requests in a very high pace environment. \u25e6 In the execution of the solid archive reformatting project, utilizing an automated labeler with troubleshooting as needed, as well as manual solid transfer with associated LIMS work. The individual will be responsible to ensure all service level agreements are achieved on daily basis including communicating with stakeholders to ensure an efficiently run operation and data integrity with supervision. The individual will coordinate incoming and outgoing compound shipments to/from CROs, partners and collaborators. The individual will perform some troubleshooting as needed with supervision. The individual will assist with regular upkeep in compound management workspace. Requirements: A minimum of Associate Degree in science or technical field with at least 0+ year of experience in Compound Management. A very high attention to detail is a must. Ability to highly multitask and be highly efficient while delivering high quality and high accuracy / precision work. Must be self-motivated with proactive and can-do attitudes, and highly reliable on deliverables. Must be highly organized, able to prioritize workload, and ask questions to fully ensure zero assumptions. Excellent analytical / problem solving, organizational, and time management skills. Excellent personal and communication skills, along with the ability to be responsive promptly, fully, and actively to research partners. Ability to work well within a team, ensuring professional and respectful work environment. Familiarity with database, file management, and working knowledge (moderate to advance level) of Microsoft Office applications are required. Experience in automation and LIMS are plus. 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Assure through audits that non-clinical CROs, clinical CROs, clinical sites and supporting services are operating in compliance with the Company's quality program, regulations/guidelines and SOPs and are acceptable for performing clinical studies and related services. Assist and/or oversee audits; develop, recommend, and follow up on corrective actions. Assist with preparations for GCP inspection-readiness for corporate Blueprint as well as CROs and investigator sites. Assist with managing GCP Inspections of Blueprint Medicines Continue to develop as an SME for areas of responsibility during regulatory inspections and assist in managing inspection back and front room activities. Provide QA oversight and auditing of TMFs. Train and mentor staff on global GCP regulations and guidances. In partnership with the Clinical Operations, Drug Safety & Pharmacovigilance, and Regulatory teams, contribute to the design and implementation of a risk-based clinical Quality Assurance management system. Review and approve CRO quality events and CAPA, as appropriate. Identify QA and compliance related issues and implement solutions to ensure timelines are maintained. Assist with establishing metrics and reporting the state of GCP Quality and compliance of clinical trials to senior management. Ensure Clinical Development activities are compliant with cGCP, cGLP, FDA, ICH, EMA regulations and guidelines and industry standards. 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