- 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
- Cognizant (Boston, MA)
- **About the role** As an **ALM** ** Validation Lead ** , you will make an impact by leading validation and testing initiatives across life sciences systems, ... transformation. You will be a valued member of the ** Quality Engineering and Assurance ** team and work...a focus on digital transformation and paperless execution. + Lead end-to-end validation and testing phases for… 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
- Abbott (Burlington, MA)
- …divisional software development and validation program. + Support audits and lead quality system improvement activities. + Additional responsibilities may be ... providing quality engineering support for software. The Senior Software Design Assurance Engineer position focuses primarily on software quality but also… more
- Eversource Energy (Westwood, MA)
- …Massachusetts** \. You will be responsible for the construction management and quality assurance of transmission line, distribution line, and substation ... + Ensure construction schedule accuracy + Ensure contractor adherence to Construction Quality Assurance plan + Manage all "out\-of\-scope" work communicating… more
- Sanofi Group (Cambridge, MA)
- …management, control implementation, and action planning. + Lead risk assessments, quality assurance strategies, and validation activities for digital ... **Job Title:** Digital Risk Advisory Lead **Location** : Cambridge, MA Morristown, NJ **About...findings through corrective/preventive action plans. + Define and implement Quality and Compliance Standards for emerging technologies, contributing to… more
- Takeda Pharmaceuticals (Boston, MA)
- …GRO, and cross-functional M&A integration teams to ensure consistent data ingestion and quality assurance across systems. + Track data-related risks, issues, and ... specifications for RIM and eDMS systems. + Oversee the execution of data remediation, migration validation , and quality control activities. + Liaise with DD&T,… 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
- Public Consulting Group (Boston, MA)
- …an SAP ECC to SAP S/4HANA RISE Migration) + Quality Assurance or Independent Verification and Validation (IV&V) experience with large HR/Financial ... providing a combination of the following services: Implementation, IV&V, project management, quality assurance (QA), and other project oversight services for… more
- Amgen (Cambridge, MA)
- …processes + Support on-going deviation/ CAPA and change control + Support/ lead Amgen primary container system supplier sterility assurance assessments for ... responsible for designing, conducting, and analyzing new process development, validation and requalification studies for gas sterilization modalities for combination… more
- Cardinal Health (Boston, MA)
- **_What Quality Assurance contributes to Cardinal Health_** Quality develops and implements quality policies, procedures, and processes to ensure ... products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost effective quality … more