17 quality analyst jobs found in Waltham

Alkermes, Inc. Job Title Senior System Analyst III - Clinical Manufacturing Suite Location Waltham, MA (Hybrid Office Schedule) Position Summary The IT Senior System Analyst III for Clinical Manufacturing Suite will lead all technology implementation, production support, and maintenance activities within the Clinical Manufacturing Suite, ensuring systems are reliable, secure, and compliant with GMP and GxP requirements. This position will be responsible for authoring and enforcing SOPs to meet GMP guidelines, onboarding and validating new equipment, maintaining compliance of existing systems, and driving the implementation of new IT GxP solutions such as Data Historian and LIMS. Partnering closely with CMC, quality, and regulatory teams, the IT Senior System Analyst III ensures alignment with FDA and global regulatory standards while fostering continuous improvement, operational excellence, and strong collaboration across the organization. The role requires deep...

CSL The Associate Director (AD), Biostatistics, leads the full scope of statistical contribution to a clinical development program. The AD provides statistical strategies for the clinical trials and regulatory submissions and is accountable for the statistical deliverables within the program. ( Positions available supporting multiple Therapeutic Areas available ) Main Responsibilities: Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area. Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews. Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents....

CSL CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. The Senior Director, Biostatistics leads the biostatistics function for Cadio and Renal Therapeutic Areas and provides strategic oversight for statistical contributions to clinical development. This role is responsible for statistical excellence in clinical development plans, trial planning, data analysis, interpretation and reporting, and regulatory interactions and submissions, while partnering closely with Clinical Development and other key stakeholders. The Senior Director manages a team of statisticians both internal FTEs and external FSPs, and contributes to innovation, operational quality, and cross-functional...

Alkermes, Inc. Position: Director, Process Development Position Summary: An exciting opportunity for an experienced leader to join as a key member of the Pharmaceutical Development team with responsibility for process development activities at the Waltham site, ensuring delivery of robust processes that enable the consistent manufacture of high quality and life changing therapeutics for patients. This position is responsible for leading and empowering the Process Development Team in taking Alkermes' drug product candidates from formulation development through process development, scale-up, optimization, process characterization, clinical production, and technical transfer to the commercial manufacturing site. The successful candidate will thrive in a highly collaborative matrix team environment to drive critical decision-making and ensure the successful development of new drugs. Responsibilities and Requirements: Lead process development strategy for...

Alkermes, Inc. We are seeking a highly motivated, experienced hands-on Associate Director of Information Security (Cloud and Emerging Technology) to take a leadership role in shaping and executing the organizations security strategy in advanced technologies. Reporting to the Director of Information Security, this position will oversee a small team of security professionals and act as a trusted advisor across IT, and business units. This role will be responsible for developing, implementing, and enforcing security frameworks and guardrails for cloud environments (primarily AWS), AI/ML platforms, Large Language Models (LLMs), and DevSecOps practices. In this role, the Associate Director will lead efforts to secure cloud and emerging technologies, ensuring compliance with regulatory requirements and alignment with organizational risk appetite. Responsibilities Essential Duties and Responsibilities Lead, mentor, and manage a small team of security professionals, fostering...

CSL CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next AD of Clinical Assay? The job is in our Waltham MA office. This is a hybrid position and is onsite three days a week. You will report to the Director of Clinical Assay. You will be part of a specialized non-laboratory based team and provide high level expertise and leadership capacity in the area of bioanalytical and biomarker assays to support nonclinical and clinical studies. This role will lead the external tactical execution of bioanalytical/biomarker assays to ensure delivery of innovative assays and key data sets to meet the business needs. Deep understanding of assay design, regulatory...

Alkermes, Inc. Reporting directly to the Head of Medical Affairs, the VP, Head of Life Cycle Management (LCM) is a highly visible and business-critical role at Alkermes. This role is tasked with understanding the business strategies and drivers underlying our medicines for the treatment of serious mental illness, sleep disorders and our emerging neuroscience pipeline and translating those drivers into data generation plans across our programs and disease areas of interest. This individual will need to effectively collaborate and communicate with colleagues within Medical Affairs and key cross-functional partners (e.g., Commercial, Clinical Development, Clinical Operations, Regulatory Affairs, Safety, Biostatistics, Program Management, Government Affairs, Business Development), and frequently represent the function to senior management and the company to healthcare professionals. This position is based in Waltham, MA. Responsibilities Lead the efforts to collaborate with...

CSL Responsible for the strategy, development, and optimization of digital platforms that support external innovation, business development, market analysis, and competitive intelligence. This role ensures the organization has a strategic edge by enabling timely, accurate, and actionable insights from external data sources, partnerships, and market signals. Main Responsibilities & Accountabilities *Lead the design and evolution of search and intelligence platforms that aggregate and analyze data from scientific literature, patents, clinical trials, market databases, and competitor pipelines*Collaborate with business development, R&D, strategy, and digital teams to define platform requirements, use cases, and key performance indicators (KPIs)*Integrate AI/ML, NLP, and semantic search technologies to enhance discovery, relevance, and insight generation*Manage external vendors and data providers, ensuring high-quality service delivery, innovation, and...

CSL CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next AD of Clinical Assay? The job is in our Waltham MA office. This is a hybrid position and is onsite three days a week. You will report to the Director of Clinical Assay. Position Description Summary: You will be part of a specialized non-laboratory-based team and provide high level expertise and leadership capacity in the area of bioanalytical and biomarker assays to support nonclinical and clinical studies. This role will lead the external tactical execution of bioanalytical/biomarker assays to ensure delivery of innovative assays and key data sets to meet the business needs. Deep...

CSL CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next Principal Biostatistician? The job is in our King of Prussia, PA, Waltham MA and Maidenhead UK office. This is a hybrid position and is onsite three days a week. You will report to the Director of Biostats. You will lead components of statistical contribution to a clinical development program. The Principal Biostatistician implements the statistical strategies for the clinical trials and regulatory submissions within the program, and is accountable for the statistical deliverables Main Responsibilities: Input to statistical strategy and ensure appropriate statistical methodologies applied...

Alkermes, Inc. Associate Director of Information Security We are seeking a highly motivated, hands-on Information Security leader with strong, broad security expertise and proven experience in Data Loss Prevention (DLP) and Data Security Posture Management (DSPM), to join our team as an Associate Director of Information Security . This is a senior technical role that combines strategic leadership with technical execution to protect sensitive data across complex environments. In addition, this role will also oversee the Information Security Third-Party Risk Management (TPRM) program, ensuring robust security practices across internal and external environments. The Associate Director will lead a small team of security professionals and will report to the Director of Information Security. Responsibilities Essential Duties and Responsibilities Lead, mentor, and manage a team of security analysts, fostering a culture of continuous improvement, accountability, and...

Alkermes, Inc. The Alkermes Patient Access Services (PAS) team provides support for patients wishing to access Alkermes products. Support includes reimbursement and access education, appointment reminder support, coordination to financial assistance and assistance locating follow on providers for site of care transitions. The Alkermes PAS team works with patients, healthcare providers and insurance companies. The Manager-HCP Experience, PAS position reports to the Senior Director - HCP Experience, PAS and will play a key role in the delivery of our case management services and patient support programs. The role will oversee the PAP program for all 3 brands in addition to a team of case managers. This position is ideal for someone who enjoys working with multiple cross-functional teams to deliver solutions that improve patient access to medications and treatment. This person will be responsible for implementing PAP program enhancements, ensuring program performance, responding...

Repligen Overview Make a global impact-join Repligen. We're united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs that improve human health worldwide. No matter your role or background, at Repligen, you will play a key part in shaping some of the most innovative and life-changing therapies in the world. We foster a culture of purpose, collaboration, and shared success-where every voice matters and every contribution drives progress. Join us! We are seeking a highly motivated Technical Applications Scientist to join the OPUS Prepacked Columns Product Management team. In this role you will serve as a technical expert bridging customer experience and product performance by managing post-sales technical inquiries, assessing product complaints and collaborating cross functionally to maintain the high quality and reliability of the OPUS pre-packed chromatography portfolio. This role requires a strong foundation in...

Alkermes, Inc. JOB DESCRIPTION Position Summary As a Senior Manager, Data Science within the INDIGO | AI Innovation Lab, you will play a hands-on role in developing analytical, traditional ML, and AI products and in supporting delivery of prioritized AI use cases on our roadmap. You will collaborate with business stakeholders on specific deliverables, maintain ownership of your work and ensure timely delivery of quality products. You will bring solid technical expertise and a strong sense of work ownership to a deeply collaborative setup, where AI innovation with strong business integration is paramount. The ideal candidate will have experience with data science and AI applications in the pharmaceutical or health-related industry. This role is based in our Waltham location and follows a hybrid office schedule. Responsibilities RESPONSIBILITIES Technical Development and Execution Design, develop, and deploy data science solutions including GenAI chatbot...

Alkermes, Inc. Director - Commercial Master Data Management The Director, Commercial Master Data Management will be responsible for establishing key Master Data assets (including Customer) as trusted sources of truth and ensuring appropriate use of Master Data by the Commercial organization. This position will define and lead Master Data Management (MDM) strategy, MDM governance, MDM capability development / enhancement, MDM operations, and Master Data integration with other data and systems in the Commercial infrastructure. This position will play a key role in the Data, Analytics & Insights organization reporting to the Head of Commercial Data Management and will lead a team of internal and external data stewards and MDM system analysts and developers. The ideal candidate should have extensive knowledge in Pharma Commercial MDM solutions and Customer/Payer/Product Master Data, understand downstream business impact, and have the ability to advocate, adopt, and lead the...

Alkermes, Inc. The Principal Scientist position within Analytical Development provides technical leadership for small molecule analytical methodologies and is a subject matter expert both within and outside the department as part of a growing, dynamic Pharmaceutical Development organization. The Principal Scientist works within the Analytical Development team to characterize drug substance, drug product, impurities, degradants, and metabolites from pre-clinical research through drug development and commercialization. The successful candidate will thrive in a highly collaborative matrix team environment to drive critical decision-making and ensure the successful development of new drugs. Responsibilities Responsibilities: Serve as the primary Analytical Development representative on CMC teams, translate program objectives into phaseappropriate analytical strategies, plans, and timelines. Provide strategic CDMO oversight for analytical activities, which may include product...

Alkermes, Inc. We are seeking a highly motivated and strategic individual for a Director of Health Economics and Outcomes Research (HEOR) role at Alkermes. This is an exciting, visible, and highly collaborative opportunity where you will play a pivotal role in executing on evidence generation plans in support of Alkermes' most advanced pipeline program in sleep-wake disorders. You will report to and support the Head of HEOR in the delivery of research activities and development of materials to support engagements with key stakeholders, including physicians, regulatory agencies, reimbursement bodies, and patients/advocates. The ideal candidate will have a strong technical background in HEOR, excellent data science and visualization skills, great written and verbal communication skills, and a proven ability to foster and manage internal and external relationships effectively. Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees...