IT Quality Lead
4 days ago
Qualifications: Providing the validation strategy for different computer systems in life sciences industry Possess expertise in managing acquisitions and divestitures from a Computer System Validation (CSV) perspective. Comprehensive understanding of the Computer System Validation process, particularly in relation to GxP applications and systems. Capability to remediate CSV Validation documentation. Strong understanding of CFR 21 Part 11 and the SDLC lifecycle related to validation requirements. Ability to work within a team and independently. Strong English communication and written skills required. Preferred Qualifications: Previous experience working for an Innovative Medicine company is preferred. Additional Experience Required: Project Leader/Senior 3-7 years of relevant experience Work independently and guide/mentor Junior resources Experience in the Pharmaceutical, biotechnology, or medical device industry 2+ years' experience with System Development Lifecycle 3+ years' experience in Computer System Validation (Based on the role selected) Experience in FDA and/or global regulated environment with good understanding of GxP standards and Risk based validation Knowledge of FDA guidance and industry standards (i.e., GAMP) Experience in writing and executing documentation for all aspects of the validation deliverables (requirements, compliance/validation plans, test protocols, test summary reports and compliance/validation reports) Experience in reviewing system test and user acceptance test scripts, traceability matrix and design specs Experience in QA Methodologies, designing, reviewing and approving test plans, systems and UAT test scripts and test procedures Ability to work with remote teams and support several changes/projects simultaneously Ability to provide validation guidance, timely reviews, and escalations to TQ management #J-18808-Ljbffr
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Quality Assurance Lead
1 week ago
Boston, United States HexaQuEST Global, Inc. Full timePrimary Responsibilities Lead test strategy, balancing priorities such as test coverage, test quality, competing demands, and project schedule. Track, measure, and report on progress identifying, writing, and executing tests, and resolving defects. Identify systemic problems, inefficiencies, risks, and opportunities for improvement; work with workstream...
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Quality Assurance Lead
3 months ago
Boston, United States HexaQuEST Global, Inc. Full timePrimary Responsibilities Lead test strategy, balancing priorities such as test coverage, test quality, competing demands, and project schedule. Track, measure, and report on progress identifying, writing, and executing tests, and resolving defects. Identify systemic problems, inefficiencies, risks, and opportunities for improvement; work with workstream...
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Lead Quality Assurance Analyst
4 days ago
Boston, United States Federal Reserve Bank of Boston Full timeLead Quality Assurance AnalystTo qualify for this role, you must be a US Citizen or US Permanent Resident and must have resided in the United States for at least the last three (3) years.This position is responsible for testing, coordinating and documenting various testing activities for critical national applications. This includes leading efforts in...
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Pharmacovigilance Quality Assurance Project Lead
3 months ago
Boston, United States Katalyst Healthcares & Life Sciences Full timeResponsibilities: PVQA Project leader consultant is responsible for the development and oversight of execution of the global PV QA audit strategy, inspection readiness, vendor oversight and metrics driven strategy. Partners with affiliates to provide guidance when needed related to regulatory compliance and will engage with them to support process...
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Senior Lead Consultant, Air Quality
3 weeks ago
Boston, United States Ramboll Full timeJob DescriptionWe prefer to have this role based out of our Westford, MA, Princeton, NJ, NYC, Boston, Portland, ME, Hartford, CT, or Blue Bell, PA offices but for the right candidate, we are open to remote working within the northeast United States.Applicants must be currently authorized to work in the United States on a full-time basis. No sponsorship is...
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Senior Lead Consultant, Air Quality
1 month ago
Boston, United States Ramboll Full timeJob DescriptionThis position is located at any one of our New England offices in Massachusetts, Maine, or Connecticut. We are also open to considering qualified candidates to work out of our Princeton, NJ, or New York office. Applicants must be currently authorized to work in the United States on a full-time basis. No sponsorship is available for this...
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Boston, Massachusetts, United States Berkshire Hathaway Specialty Insurance Full timeAbout the JobWe are seeking a highly experienced IT Quality Assurance Lead to join our Boston-based Information Technology Team at Berkshire Hathaway Specialty Insurance (BHSI). As a key member of our team, you will be responsible for engaging business users and IT team members throughout the lifecycle of projects and production.Key ResponsibilitiesDriving...
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Pharmacy Technician Team Lead
4 weeks ago
Boston, Massachusetts, United States Mass General Brigham Full timeJob SummaryMass General Brigham is seeking a skilled Pharmacy Technician Team Lead to supervise and lead a team of pharmacy technicians in the day-to-day activities of the pharmacy department. The ideal candidate will have a strong background in pharmacy operations and a passion for quality assurance.Key ResponsibilitiesSupervise and Lead Pharmacy...
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Technical Quality Assurance Lead
6 days ago
Boston, Massachusetts, United States Berkshire Hathaway Specialty Insurance Full timeCompany OverviewBerkshire Hathaway Specialty Insurance (BHSI) is a strategic and trusted insurance partner that provides a broad range of commercial property, casualty, and specialty insurance coverages and outstanding service to customers and brokers around the world. As part of Berkshire Hathaway's insurance operations, we bring our solutions to market...
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Quality Manager
4 weeks ago
Boston, United States Precede Full timeThe OpportunityOur Operations & Strategy team is expanding. We're looking for a builder and doer, a teammate who is motivated by a mission and wants to put their imprint on a scaling company.We are looking for a Quality Manager to join our team to ensure testing in our R&D and clinical laboratory is of exceptional quality and accuracy.In this role you will...
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Director of Quality
1 month ago
Boston, United States Jobot Full timeJob DescriptionJob DescriptionRare Disease Biotech Company Looking for Director of QualityThis Jobot Job is hosted by: Victoria CasalAre you a fit? Easy Apply now by clicking the "Apply Now" buttonand sending us your resume.Salary: $165,000 - $210,000 per yearA bit about us:Rare Disease Biotech based in BostonWhy join us?Competitive Base Full Benefits PTO...
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Boston, Massachusetts, United States Boston Children's Hospital Full timeAbout Boston Children's HospitalWe are a leading pediatric hospital dedicated to providing exceptional care to children and their families. Our team of experts is committed to delivering innovative, family-centered care that exceeds expectations.
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Director of Quality Assurance
3 months ago
Boston, United States Page Mechanical Group, Inc. Full timeJOB TITLE: Director, Quality AssuranceDEPARTMENT: Quality Assurance DATE PREPARED: September 10, 2024JOB SUMMARY:The Director of Quality Assurance at AVEO Oncology reports to the Vice President Quality Assurance and is responsible for Quality Operations at AVEO including quality strategic leadership and compliance activities related to the cGMP manufacture...
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Director of Quality Assurance
1 week ago
Boston, United States Aveo Pharmaceuticals Inc Full timeJOB TITLE: Director, Quality Assurance DEPARTMENT: Quality Assurance DATE PREPARED: September 10, 2024JOB SUMMARY: The Director of Quality Assurance at AVEO Oncology reports to the Vice President Quality Assurance and is responsible for Quality Operations at AVEO including quality strategic leadership and compliance activities related to the cGMP manufacture...
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Quality Assurance Director
6 days ago
Boston, Massachusetts, United States Aveo Pharmaceuticals Inc Full time• Develop and implement a robust Quality Management System ensuring outsourced GMP operations comply with regulations and industry standards.• Provide strategic direction and oversight of Quality Assurance activities across product development and commercialization.• Lead cross-functional initiatives promoting a culture of continuous improvement,...
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Director of Quality and Safety
3 weeks ago
Boston, United States AAGL Full timeThe Director for Quality and Safety for the Department of Obstetrics and Gynecology directs quality and safety efforts in both inpatient and ambulatory settings. The Director will report directly to the Department Chair and will collaborate with the Vice Chairs of Clinical Operations, DEI, and Research to optimize and oversee the quality and safety...
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Quality Control Manager
4 weeks ago
Boston, United States Elgen Staffing Full timeOur client, a nationwide distributor of fresh seafood, has an immediate need for an experienced Quality Control Manager, to join their winning team in Boston. Our candidate of choice will be responsible for managing all the quality aspects of their production facility and ensuring that all seafood products are manufactured in compliance with specific...
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Director of Quality and Safety
4 weeks ago
Boston, United States AAGL, Inc. Full timeThe Director for Quality and Safety for the Department of Obstetrics and Gynecology directs quality and safety efforts in both inpatient and ambulatory settings. The Director will report directly to the Department Chair and will collaborate with the Vice Chairs of Clinical Operations, DEI, and Research to optimize and oversee the quality and safety...
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Director of Quality and Safety
4 weeks ago
Boston, United States Boston Medical Center Full timeThe Director for Quality and Safety for the Department of Obstetrics and Gynecology directs quality and safety efforts in both inpatient and ambulatory settings. The Director will report directly to the Department Chair and will collaborate with the Vice Chairs of Clinical Operations, DEI, and Research to optimize and oversee the quality and safety...
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Director of Quality and Safety
4 weeks ago
Boston, United States Boston Medical Center Full timeThe Director for Quality and Safety for the Department of Obstetrics and Gynecology directs quality and safety efforts in both inpatient and ambulatory settings. The Director will report directly to the Department Chair and will collaborate with the Vice Chairs of Clinical Operations, DEI, and Research to optimize and oversee the quality and safety...