- Astellas Pharma (Westborough, MA)
- ** Validation Lead , Quality Assurance ** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we ... programs. AIRM is headquartered in Massachusetts. Astellas is announcing a ** Validation Lead , Quality Assurance ** opportunity at their **Astellas… more
- Hologic (Marlborough, MA)
- Lead Design Assurance Engineer Newark, DE, United States Marlborough, MA, United States Are you passionate about driving innovation while ensuring compliance and ... medical device development? At Hologic, we are seeking a ** Lead Design Assurance Engineer** to play a...equipment is preferred. + Proven track record in design assurance activities, including verification/ validation , risk management, and… more
- Bristol Myers Squibb (Devens, MA)
- …of appropriate validation methodologies in collaboration with Operations Management and Quality Assurance for novel projects. + Review and approve ... Lead as appropriate. + Drive and own the validation lifecycle documentation for newly implemented computerized systems +...environment with at least four (4) years focused on quality assurance , validation , or compliance… more
- Hologic (Marlborough, MA)
- Lead Software Design Assurance Engineer Marlborough, MA, United States Newark, DE, United States Are you passionate about ensuring the quality , safety, and ... reliability of life-saving medical device software? Hologic is seeking a ** Lead Software Design Assurance Engineer** to play a critical role in driving… more
- Astellas Pharma (Westborough, MA)
- **Manager, Quality Assurance Compliance** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are ... AIRM is headquartered in Massachusetts. Astellas is announcing a **Manager, Quality Assurance Compliance** opportunity at their **Astellas Institute for… more
- Bristol Myers Squibb (Devens, MA)
- …lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Manager, Quality Assurance - Lab Operations is responsible for leading ... oversight for GMP laboratory operations, including QC testing, method validation , and stability studies. + Lead QA...a related field. + 8+ years of experience in Quality Assurance or Quality Control… more
- Hologic (Marlborough, MA)
- …personnel development to meet divisional strategies and goals. + **Team Management** : + Lead the BSH Design Assurance team, including managers and Design ... Director, Design Assurance Newark, DE, United States Marlborough, MA, United...with a passion for ensuring the highest standards of quality in medical device design and development? We are… more
- Hologic (Marlborough, MA)
- …required; Master's or Ph.D. preferred. + 10+ years of experience in Design Assurance , Quality Engineering, or related technical roles within the medical device ... Principal Design Assurance Engineer Newark, DE, United States Marlborough, MA,...MA, United States Are you ready to take the lead in ensuring the safety, reliability, and compliance of… more
- Sanofi Group (Framingham, MA)
- …team environment and interact with other support groups such as HSE, Engineering, Facilities, Validation , Quality Assurance and Supply Chain. + Complete all ... **Job Title:** Facilities and Engineering APU Lead **Location** : Framingham, MA **About the Job**...and direction to staff consistent with cGMP and corporate quality governance + Coach and mentor staff in all… more
- Bristol Myers Squibb (Devens, MA)
- …LIMS, MES, and digitized quality platforms. + Proven ability to lead quality support for process development, MS&T, and external manufacturing initiatives. ... key leader within the GCTQ Organization. This role will lead a global team of quality professionals...cell and gene therapies. + Combination of experience in quality assurance , quality control, and… more
- Actalent (Bedford, MA)
- …Engineer to lead the development and execution of comprehensive hardware quality assurance plans. This role involves designing, implementing, and overseeing ... to ensure objectives and success criteria are defined. + Lead Verification & Validation planning and execution...plans and protocols. + Strong skills in design verification, validation , and quality planning. + Ability to… more
- Danaher Corporation (Waltham, MA)
- …workflows. + Experience of working in a product development, technology transfer or validation role. Experience of Quality Assurance is advantageous. + ... possible. The Senior Scientist - Technology Transfer - US Lead is responsible for ensuring efficient transfer of products...this role, you will have the opportunity to: + Lead and coordinate global technology transfers across sites and… more
- Sanofi Group (Framingham, MA)
- …gowning, aseptic processes and practices and industrial supplies, etc.) and Qualification/ Validation for processes (microbio strategy) + Ensuring the **compliance of ... and processes** with applicable contamination control regulatory requirements and company quality standards + Maintaining a system to ensure **contamination risks**… more
- BJs Wholesale Club (Marlborough, MA)
- …We are seeking a highly skilled and experienced Senior IT QA Analyst to lead quality assurance efforts for BlueYonder Planning, Allocation, and WMS/TMS ... practices, and hands-on experience with BlueYonder implementations. Key Responsibilities: + Lead QA planning, strategy, and execution for BlueYonder modules across… more
- Sumaria Systems, Inc. (Bedford, MA)
- …that involves the planning, analysis, design, development, testing, quality assurance , configuration, installation, implementation, integration, maintenance, ... action using the application of engineering economy principles + Perform validation of systems, including the development of criteria and procedures. Analyze… more
- Bristol Myers Squibb (Devens, MA)
- …and provide Operations project information and activities status to Planning, Manufacturing, Quality Assurance / Operations, Global Supply and other associated ... and operational issues to prevent deviations and maintain a compliant environment. Lead and manage the development of corrective and preventative actions, deviation… more
- State of Massachusetts (Maynard, MA)
- …duties, as required. * Ensure compliance with the laboratory's administrative policies, quality assurance / quality control requirements and ANAB accreditation ... grade based upon caseload, staffing strengths and other personnel considerations. * Lead activities, and provide training and direction in projects, processes, and… more
- Sanofi Group (Framingham, MA)
- …and Project Management) and with other Sanofi functions (eg, Research, Quality Assurance , Regulatory Affairs, Manufacturing & Supply, Business Development). ... biophysical methods, biochemical methods, immunoassays, and bioassays. + **Activities:** Lead method development, qualification, validation , methods transfer,… more