Clicking Apply Now takes you to AutoApply where you can tailor your resume and apply.
Experience Level
Senior Level Manager
Qualifications
Proven experience in clinical quality assurance within the pharmaceutical industry. Strong knowledge of FDA regulations and ICH guidelines. Excellent leadership and communication skills. Ability to work collaboratively in a fast-paced environment. Advanced degree in a relevant field is preferred.
About the job
Deciphera Pharmaceuticals, Inc. is hiring a Senior Manager, Clinical Quality Assurance in Waltham. This position leads the Clinical Quality Assurance team and plays a central role in maintaining high standards for clinical trial quality and regulatory compliance.
Role Overview
The Senior Manager, Clinical Quality Assurance develops and implements quality assurance strategies for clinical programs. The role involves oversight of compliance with regulatory requirements and internal quality expectations throughout all phases of clinical trials.
Key Responsibilities
Lead the Clinical Quality Assurance team
Develop and execute quality assurance strategies for clinical trials
Conduct audits to assess compliance with regulatory standards
Ensure all clinical trial activities meet regulatory and company quality requirements
What We’re Looking For
Extensive experience in clinical quality assurance
Strong knowledge of regulatory requirements for clinical trials
Proven ability to develop and implement quality assurance processes
Experience conducting audits in a clinical setting
About Deciphera Pharmaceuticals, Inc.
Deciphera Pharmaceuticals is committed to providing innovative therapies for patients with cancer. Our team is driven by a passion for science and a dedication to making a difference in patients' lives. We foster a collaborative environment that encourages creativity and growth.
Full-time|On-site|Waltham, Massachusetts, United States
This Associate II, Quality Control role at elevatebio focuses on maintaining rigorous quality standards for products and processes. The position is located in Waltham, Massachusetts and supports the company's commitment to compliance and operational excellence. Key Responsibilities Perform quality assessments to ensure both compliance and consistency across …
At Crescent Biopharma, we aspire to transform the landscape of oncology by developing cutting-edge therapies tailored for cancer patients. Our innovative pipeline includes a leading PD-1 x VEGF bispecific antibody, alongside state-of-the-art antibody-drug conjugates. By harnessing diverse therapeutic modalities and established targets, we aim to expedite the development of potentially groundbreaking treatments, whether as standalone interventions or in combination therapies targeting various solid tumors. For more insights into our mission and vision, visit our website and connect with us on LinkedIn and X.We are currently in search of an Associate Director or Director of Analytical & GMP Quality Assurance Operations. In this pivotal role, you will oversee and guide the QA functions related to analytical development, quality control operations, and GMP quality activities across our clinical-stage biologics and ADC programs. Collaboration with cross-functional teams, including CMC, Analytical Sciences, Quality Control, and Technical Operations, as well as external manufacturing and testing partners, will be key to ensuring compliance with phase-appropriate GMP standards, maintaining data integrity, and ensuring inspection readiness within a dynamic outsourced operational framework. Your strategic vision will be instrumental in shaping Crescent's analytical quality strategy and driving the disciplined execution of core quality systems that align with our aggressive development timelines.
Join Artech Information Systems LLC as a Scientist II, where you will play a pivotal role in advancing our innovative solutions. As a mid-senior level scientist, you will be involved in cutting-edge research and development projects, utilizing your expertise to drive results and contribute to our team's success.
We are seeking a highly skilled and motivated Scientist II to join our dynamic team. In this role, you will leverage your expertise to contribute to innovative research and development projects. The ideal candidate will possess a strong background in scientific methodologies and a passion for advancing knowledge in their field.
Join our dynamic team at Artech Information Systems LLC as a Scientist II, where your expertise will contribute to cutting-edge research and innovation. We are seeking a detail-oriented and motivated individual to engage in scientific projects that push the boundaries of technology and discovery.
About the Role New England Donor Services is seeking a Quality Systems Specialist I in Waltham. This entry-level position supports the organization’s commitment to quality by helping to develop, implement, and maintain quality systems that meet industry regulations and standards. What You Will Do Assist with the creation and improvement of quality systems and processes Help ensure compliance with relevant regulations and industry standards Support ongoing maintenance and documentation of quality procedures
At Xometry (NASDAQ: XMTR), we empower the industries of today and tomorrow by connecting visionary thinkers with manufacturers capable of turning their ideas into reality. Our digital marketplace equips manufacturers with the essential tools to expand their businesses while providing Fortune 1000 companies seamless access to global manufacturing capabilities.We are on the lookout for dynamic Quality Engineers to join our team and support our rapid growth. Are you someone who thrives in challenging environments? Do you aspire to revolutionize an industry? If your strength lies in prioritizing tasks and communicating effectively, then this role could be your next great adventure.As a Quality Assurance Engineer, you will collaborate with a fast-paced team of engineering experts to address quality assurance challenges for customized parts. You will also assist the Senior Director in developing our quality systems in line with corporate policies and AS9100 standards.
Join Artech Information Systems LLC as a Research Associate II, where you will contribute to exciting projects in a dynamic environment. This role is ideal for individuals looking to kickstart their career in research with a focus on innovative solutions and data-driven insights.
Full-time|$213K/yr - $240K/yr|Remote|Waltham, Massachusetts, United States
About Us:At Oruka Therapeutics (Nasdaq: ORKA), we are pioneering innovative biologics aimed at transforming the treatment landscape for chronic skin disorders. Our mission is to empower individuals battling chronic skin conditions, such as plaque psoriasis, by providing them with the utmost freedom from their ailments, achieving significant disease clearance through infrequent dosing, potentially just once or twice yearly. Our proprietary collection of antibodies, meticulously crafted by Paragon Therapeutics, targets the fundamental mechanisms of plaque psoriasis and other dermatological and inflammatory conditions. To learn more, visit www.orukatx.com.As we expand our core team, we are on the lookout for exceptional talent across various functional areas—individuals who seek more than just employment, but rather a chance to be part of something transformative. We value passion for making a difference and contributions to fostering an engaged, inclusive, and positive workplace culture.Job Title: Director of Clinical Quality AssuranceLocation: Remote; candidates located in the Waltham, MA area are preferred.Role Overview:The Director of Clinical Quality Assurance will provide strategic leadership and oversight for Oruka's clinical development initiatives, focusing primarily on Good Clinical Practice (GCP) and associated quality systems that support clinical trials. This role will establish, enhance, and oversee clinical quality processes appropriate to each phase, ensuring comprehensive supervision of clinical trial execution and vendor performance while preparing for global health authority inspections, including FDA Bioresearch Monitoring (BIMO) inspections.This position will collaborate closely with Clinical Operations, Clinical Development, Biometrics, Pharmacovigilance, Regulatory Affairs, Medical Writing, and external service providers to ensure compliance with GCP, relevant global regulations, internal procedures, and protocol requirements throughout the clinical trial lifecycle. The Director of Clinical QA will proactively contribute quality insights, support continuous improvement initiatives, and help cultivate a quality-centric culture as the organization progresses with its pipeline.Key Responsibilities:Clinical Quality Oversight: Ensure compliance with GCP and applicable regulatory requirements for new and ongoing clinical studies.
About the Role Zenas Bio is looking for a Director of Global Quality Assurance with expertise in Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). This leader will guide the company’s quality assurance activities and maintain compliance with regulatory standards. Key Responsibilities Oversee global quality assurance processes related to GCP and GLP. Ensure all practices meet current regulatory requirements and industry standards. Location This position is based in Waltham, MA.
Full-time|$43.27/hr - $57.69/hr|On-site|Waltham, Massachusetts, United States
ElevateBio develops and manufactures advanced therapies, working with partners from early stages through to commercialization. The company combines a range of technologies, services, and manufacturing expertise to help advance new therapies efficiently. Role overview The Quality Assurance Validation Specialist I will join the QA Validation Group and focus on Commissioning and Qualification (CQV) activities for quality control laboratories, manufacturing suites, and related equipment. This position supports quality assurance within a cGMP environment. Main responsibilities Oversee QA activities for CQV processes in cGMP manufacturing facilities and quality control labs. Manage QA oversight for periodic reviews and requalification programs. Review Computerized Maintenance Management System (CMMS) records for asset management, including asset release, database requests, and work orders. Provide QA oversight for quality events related to validation and engineering, such as deviations and CAPAs. Contribute feedback as part of cross-functional teams on inspection readiness activities. Author and review Standard Operating Procedures (SOPs) in Veeva. Requirements Strong understanding of Commissioning and Qualification processes for laboratory and manufacturing environments, including equipment and instrumentation. This role is based in Waltham, Massachusetts.
Deciphera Pharmaceuticals, Inc. is hiring a Senior Manager, Clinical Quality Assurance in Waltham. This position leads the Clinical Quality Assurance team and plays a central role in maintaining high standards for clinical trial quality and regulatory compliance. Role Overview The Senior Manager, Clinical Quality Assurance develops and implements quality assurance strategies for clinical programs. The role involves oversight of compliance with regulatory requirements and internal quality expectations throughout all phases of clinical trials. Key Responsibilities Lead the Clinical Quality Assurance team Develop and execute quality assurance strategies for clinical trials Conduct audits to assess compliance with regulatory standards Ensure all clinical trial activities meet regulatory and company quality requirements What We’re Looking For Extensive experience in clinical quality assurance Strong knowledge of regulatory requirements for clinical trials Proven ability to develop and implement quality assurance processes Experience conducting audits in a clinical setting
Role overview Boston Engineering Corporation seeks a Senior Electrical Engineer specializing in embedded systems and controls. This full-time position is based in Waltham and centers on designing and developing electrical solutions for a variety of projects. What you will do Design and develop electrical systems tailored to embedded and control applications Collaborate with engineers from different disciplines to integrate solutions Apply technical expertise to projects serving multiple industries Team and impact This role works closely with a skilled engineering team to deliver solutions that support client innovation. Projects span several industries, contributing to ongoing advancements at Boston Engineering Corporation.
We are seeking a passionate and detail-oriented Quality Assurance Analyst to join our dynamic team in Waltham. In this role, you will play a critical part in ensuring the quality and reliability of our software products through rigorous testing and analysis. You will collaborate closely with developers and project managers to identify issues and recommend solutions, contributing to our commitment to excellence.
Full-time|$140.8K/yr - $176K/yr|On-site|Waltham, MA
Zenas BioPharma is a pioneering biopharmaceutical company at the forefront of developing and commercializing transformative therapies for patients suffering from autoimmune diseases. Our strategic approach combines a seasoned leadership team with a rigorous process for acquiring and developing innovative product candidates globally. We are focused on delivering superior clinical benefits to patients affected by autoimmune disorders. We are advancing two late-stage flagship molecules: obexelimab and orelabrutinib. Obexelimab is our lead candidate, a bifunctional monoclonal antibody targeting CD19 and FcγRIIb, aimed at inhibiting the activity of pathogenic B cells without causing depletion. This innovative therapy offers a self-administered subcutaneous injection regimen, addressing chronic autoimmune diseases effectively. Orelabrutinib, on the other hand, is a highly selective oral small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor, designed to tackle compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). We also have promising earlier-stage programs, including a preclinical oral IL-17AA/AF inhibitor and a brain-penetrant TYK2 inhibitor.We are on the lookout for exceptional talent who share our dedication to improving patient outcomes and possess a proven track record in global product acquisition, development, and commercialization. Joining Zenas provides an opportunity to thrive in a dynamic learning environment where individual and organizational success is paramount as we aspire to become a global leader in immunology and autoimmune disease management. Our core values—Transparency, Relationships, Urgency, Excellence, and Innovation—drive us toward TRUE Innovation!Position Summary:As the Senior Manager of Global Quality Assurance for Technical Operations, you will report directly to the Director of Global Quality Assurance for Medical Devices and Combination Products. This strategic role encompasses hands-on quality oversight for late clinical-stage and commercial manufacturing activities at Zenas BioPharma’s Contract Manufacturing Organizations (CMOs). You will ensure the highest standards of GMP compliance across our global operations, facilitate regulatory submissions and inspections, and drive continuous improvement initiatives alongside internal teams and external manufacturing partners. Your responsibilities will include overseeing batch manufacturing and testing, process validation, and ensuring inspection readiness to maintain robust product quality throughout the development lifecycle.
Join Integrated Resources Inc. as a Stability Associate, where you will play a crucial role in ensuring product stability and compliance. In this dynamic position, you will assist in conducting stability studies and compiling data to support product releases.
Join Integrated Resources, Inc. as a Stability Associate, where you will play a crucial role in ensuring the quality and reliability of our products. Collaborate with a dynamic team that values innovation and excellence.
Join Crescent Biopharma as a Senior Director of R&D Quality Assurance!Crescent Biopharma is on a mission to revolutionize oncology by developing cutting-edge therapies for cancer patients. Our clinical-stage pipeline showcases our leading program, a PD-1 x VEGF bispecific antibody, alongside innovative antibody-drug conjugates. Through the strategic utilization of diverse modalities and established therapeutic targets, we aim to swiftly propel potentially transformative treatments, whether as standalone therapies or in combination regimens targeting a variety of solid tumors.As a key leader in our Quality organization, the Senior Director, R&D Quality (GCP–GLP–GvP) will deliver both strategic and hands-on leadership in Quality Assurance across clinical and nonclinical domains.
Full-time|On-site|Waltham, Massachusetts, United States
Biocytogen is seeking a Business Operations Associate in Waltham, Massachusetts. This position centers on improving internal processes and supporting ongoing projects within the company. Role overview The Business Operations Associate will work closely with teams to streamline operations and help implement project management strategies. The role involves identifying areas for improvement and contributing to initiatives that strengthen overall business performance. Key responsibilities Support operational process optimization across departments Assist with project management tasks and coordination Contribute to strategic initiatives aimed at improving business outcomes Location This position is based in Waltham, Massachusetts.
Full-time|On-site|Waltham, Massachusetts, United States
Biocytogen is a leading provider of comprehensive research and discovery services tailored for the biotech and pharmaceutical industries, as well as academic institutions. Our innovative service platform seamlessly integrates preclinical studies with advanced animal models, CRISPR-based gene editing, and animal supplies, with a key emphasis on immuno-oncology and oncology. We are seeking a dynamic and highly motivated Research Associate who thrives both independently and as part of a collaborative team. As a rapidly growing organization, Biocytogen offers numerous opportunities for career advancement and is dedicated to nurturing junior scientists in a supportive environment where they can flourish and excel. Key Responsibilities: ● Conduct preclinical pharmacology studies using rodent models, which include drug administration via various routes (IV, IP, SC, PO, etc.), blood and tissue collection, and tumor volume measurements. Experience with small animal surgery is advantageous.● Collaborate and communicate effectively with other scientists on project teams to draft, finalize, and execute study protocols. Adhere to protocols while executing tasks independently.● Collect and accurately record data. Prepare summaries of experimental procedures and results, and present findings during team meetings.● Develop, perform, interpret, and troubleshoot a wide range of in vitro assays, including immune cell profiling, cytokine profiling, functional assays using primary cells, as well as cytotoxicity and apoptosis assays with primary and/or cultured cells.● Innovate and enhance our assay portfolio by identifying, evaluating, and implementing new assay technologies through literature research, academic collaborations, and adaptations from other teams within the company.
