- Curia (Hopkinton, MA)
- …be considered. + Proven track record of leading analytical development in a GMP -regulated environment and collaborating with operations and Quality teams. + ... Director , Analytical Development in Hopkinton, MA Build your...has the power to save lives Curia is a global contract development and manufacturing organization (CDMO) with over… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Director , Global Product Quality , GMP Processes is a strategic leadership role responsible for **benchmarking, standardizing, and optimizing ... continuous improvement** across all regions and product lines. The Director will lead global initiatives to harmonize...operational efficiency. + GMP Compliance: Ensure all quality processes meet global regulatory requirements (eg,… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Job Summary** The Associate Director , Global Product Quality - Biologics is responsible for directing quality oversight of clinical and commercial ... product integrity while optimizing operational efficiency. + Works collaboratively within the Global Quality Dept. and other functions within OAPI and OPDC… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Associate Director of Global Supplier Quality will be responsible for the execution of supplier quality audit and monitoring across the company's ... + **Compliance & Documentation** + Ensure supplier compliance with global regulatory requirements (eg, FDA, EMA, ICH). + Prepare..., with 2+ years in supplier or external manufacturing quality . + Strong knowledge of GMP regulations… more
- Catalent Pharma Solutions (Chelsea, MA)
- Director of Quality Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, ... Catalent Pharma Solutions in Chelsea, MA is hiring a Director of Quality who will provides leadership...Quality Control and batch release within a pharmaceutical GMP environment required; + Leadership experience supervising a team… more
- Alloy Therapeutics (Waltham, MA)
- …We are Alloy Therapeutics -a biotechnology ecosystem company empowering the global scientific community to make better medicines together. Through a community ... aspire to work together to exceed expectations and collectively contribute across the global organization to always maintain our nimble, startup culture. This is an… more
- Sanofi Group (Waltham, MA)
- **Job Title:** Associate Director , Genomic Medicine Purification Process Development **Location:** Waltham, MA Work Model: M-F onsite **About the Job** Are you ready ... an experienced purification process development professional with experience in GMP manufacturing and technology transfer (TT) to join the...located in Waltham, MA in the role of Associate Director . The GMU PPD group operates with the mission… more
- Amgen (Cambridge, MA)
- …mentoring, training, and compliance to standard operating procedures, regulatory requirements, and quality systems in a GMP environment. + Recruit and retain ... Join us and transform the lives of patients while transforming your career. ** Director , Commercial Drug Products & Life Cycle Management** **What you will do** Let's… more
- Hologic (Marlborough, MA)
- …ISO 14971), MDSAP, and other global regulatory requirements. + Expertise in Quality Systems and GMP compliance in regulated industries such as medical ... a pivotal role in ensuring the effectiveness of our global Quality Systems. In this critical leadership...training. + Minimum of 10 years of experience in Quality Systems and GMP within medical devices,… more
- Sumitomo Pharma (Boston, MA)
- …Director , Commercial Manufacturing Validation** . This role functions within SMPA's Global Technology and Quality organization. In this capacity, the ... Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations...are implemented and updated for all development and commercial GMP programs. The individual must have the ability to… more
- Lilly (Boston, MA)
- …to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work ... scientific rigor and discovery research in gene therapy and interface with formal GMP manufacturing. The Lilly Genetic Medicine team strives to operate as an agile… more
- Takeda Pharmaceuticals (Boston, MA)
- …Sciences + Strong understanding of CMC processes, GxP, regulatory compliance and global quality standards + Demonstrated ability to lead product teams ... / Purpose:_** The Head of Design & Delivery, PharmSci will lead the global digital product strategy across Takeda's Pharmaceutical Sciences Digital Data & Technology… more
- Bristol Myers Squibb (Devens, MA)
- …partners** + Cell Therapy functions (CT Development, CT Drug Product Operations, CT Quality , VExMO, CTTO, Supply Chain, Finance, Regulatory, etc.) + GPS and Cell ... leadership & collaboration working in, or closely with, Supply Chain, GMP Manufacturing Operations, Manufacturing Science & Technology, Project & Program management,… more
- Bristol Myers Squibb (Devens, MA)
- … Quality Assurance team to succeed. This position reports to the Associate Director , Shop Floor Quality Assurance. This is an individual contributor role ... no better place than here at BMS with our Cell Therapy team. The Quality Assurance Shop Floor (QASF) organization has responsibility for quality oversight and… more
- Corning Incorporated (Tewksbury, MA)
- …Come break through with us. As a leading developer, manufacturer, and global supplier of scientific laboratory products for 100 years, Corning's Life Sciences ... productivity and enable breakthrough discoveries. **Role Purpose** Reporting to the Business Director for Media and Serum, the Sr. Product Line Manager, Serum, has… more
- Stantec (Boston, MA)
- …us create buildings that matter to our world. Together, we are enhancing the quality of life globally through design. Join us and design your place with Stantec. ... FDA or similar facilities where drug products are manufactured, stored in GMP conditions and distributed, including computerized and automated systems which require… more
- Charles River Laboratories (Boston, MA)
- …and safe manufacture of new drug therapies, making a profound impact on global health. Our 20-year partnership with Boston Children's Hospital takes this mission to ... Boston Children's, their commitment to diversity drives the exceptional quality of care provided to patients from local communities...for upcoming cases. + Work closely with the surgical director to perform daily health assessments of the USDA… more
- Bristol Myers Squibb (Devens, MA)
- …a solid working relationship with internal manufacturing, Site Engineering, and Quality departments. This position also a solid working relationship with external ... delays and financial impact. + Position is supervised by Director , Utilities & Sustainability. Daily direction and alignment is...operations of large scale production facilities, as well as GMP experience. + Candidate must be effective in both… more
