Senior Manager, Global Quality Assurance in Technical Operations

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 deliver…

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 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.

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.

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.

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.

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.

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.

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.

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 are at the forefront of innovation, connecting visionary thinkers with manufacturers capable of turning their ideas into reality. Our digital marketplace equips manufacturers with essential resources for growth while enabling Fortune 1000 companies to seamlessly access global manufacturing capabilities.We are on the lookout for a Senior Case Manager to become an integral part of our expanding team. In this pivotal role, you will be instrumental in addressing intricate customer and partner challenges. The ideal candidate will exhibit exceptional organizational skills, a solutions-focused mindset, and a proven track record in managing escalations within a dynamic, technology-driven environment. As a Senior Case Manager, you will take the lead in resolving high-stakes cases involving customers, manufacturing partners, logistics, and internal teams, ensuring that our support is timely, empathetic, and in line with Xometry's dedication to delivering world-class service.

About Us: Cogent Biosciences is a publicly traded biotechnology firm dedicated to pioneering innovative precision therapies aimed at addressing significant medical needs across diverse patient populations. Our flagship product, bezuclastinib, is engineered to effectively inhibit exon 17 mutations in the KIT receptor tyrosine kinase, particularly the KIT D816V mutation, which is implicated in Systemic Mastocytosis and gastrointestinal stromal tumors (GIST). We have observed promising initial results from our clinical trials (APEX, SUMMIT, PEAK), showcasing a favorable safety profile across over 600 patients receiving both monotherapy and combination treatments. The Opportunity: We are seeking a dynamic individual for the pivotal role of Senior Manager/Associate Director of Marketing Operations. This position will oversee the execution of strategic marketing operations to facilitate the launch of bezuclastinib, ensuring efficient, compliant, and impactful delivery of promotional materials and omnichannel campaigns. You will work closely with brand leaders to create a unified promotional strategy that enhances customer experience, drives brand performance, and supports commercial growth. Key Responsibilities: Omnichannel Campaign Management: Collaborate with the marketing team to develop and implement complex customer engagement strategies across healthcare professionals, patients, and caregivers. Partner with analytics teams to incorporate insights into campaign design and continuous improvement. Ensure readiness of systems and platforms for tracking key performance metrics and campaign effectiveness. Utilize data and segmentation strategies to ensure personalized outreach to target audiences. Promotional Review and Content Approval: Oversee the internal promotional review process (MLR) and navigate the content approval path for key commercial materials.

Xometry (NASDAQ: XMTR) is at the forefront of innovation, bridging the gap between visionary thinkers and manufacturers capable of transforming ideas into reality. Our cutting-edge digital marketplace equips manufacturers with essential tools to expand their operations, while facilitating seamless access to global manufacturing capabilities for Fortune 1000 companies.We are currently in search of a dynamic and results-oriented Senior Operational Excellence Manager to become an integral part of our expanding team. This role is tailored for an analytical strategist and proactive executor, adept at scrutinizing operational and customer service data, pinpointing inefficiencies and performance gaps, and converting insights into tangible enhancements. In collaboration with cross-functional teams including Customer & Partner Support and Partner Network Management, you will spearhead scalable process improvements and establish standards that boost efficiency, elevate customer and partner satisfaction, and enhance financial outcomes.

Zenas Bio is at the forefront of biopharmaceutical innovation, dedicated to transforming the lives of patients with autoimmune diseases through the development and commercialization of groundbreaking therapies. Our strategic approach leverages a seasoned leadership team and a meticulous product acquisition strategy to identify, acquire, and develop promising therapies worldwide. We are currently advancing two late-stage candidates: obexelimab and orelabrutinib. Obexelimab, our leading candidate, is a unique bifunctional monoclonal antibody targeting both CD19 and FcγRIIb to inhibit the pathological activity of B cells involved in autoimmune diseases, while preserving their presence. This innovative therapy is designed for self-administration via subcutaneous injection, offering a potentially effective solution for chronic autoimmune conditions. Meanwhile, orelabrutinib is a highly selective, oral Bruton’s Tyrosine Kinase (BTK) inhibitor with the potential to manage compartmentalized inflammation in Multiple Sclerosis (MS). Our earlier-stage pipeline includes a preclinical, oral IL-17AA/AF inhibitor and a brain-penetrant TYK2 inhibitor, both of which hold promise for advancing patient care.We are on the lookout for exceptional talent who share our passion for patient care and have a proven record in product development and commercialization on a global scale. At Zenas, you will thrive in a dynamic learning environment, contributing to our mission of becoming a global leader in immunology and autoimmune disease treatment while embodying our core values of Transparency, Relationships, Urgency, Excellence, and Innovation – TRUE Innovation!Position Summary:The Senior Director of Regulatory Affairs (RA) will act as the Global Regulatory Lead for a multi-indication late-phase investigational product, overseeing global regulatory submissions in the US and EU, and contributing to the advancement of Phase 2 indications through clinical development planning. This role will also involve managing regulatory strategies for at least one early-phase investigational product, including the preparation and submission of IND/CTA/amendments and future marketing applications. The Senior Director will provide strategic guidance on regulatory submissions, responses, and essential regulatory intelligence, while collaborating with a diverse cross-functional team and key internal and external stakeholders.

Join us at Xometry as a Senior Analyst in Operational Excellence, where you will play a pivotal role in enhancing our operational processes. You will collaborate with cross-functional teams to identify areas for improvement, implement best practices, and drive continuous improvement initiatives. Your analytical skills will be crucial in interpreting data and providing actionable insights that will help optimize our operations and contribute to the overall success of the company.

At Constant Contact, we pride ourselves on our exceptional team that embodies ownership, integrity, and the courage to make a real difference. There’s something immensely fulfilling about knowing your contributions help individuals everywhere pursue their aspirations. We play a crucial role in empowering business owners, entrepreneurs, non-profits, and individuals by providing them with the necessary tools and support to thrive online. We embrace new challenges and opportunities, and we’re just getting started!We are in search of a hands-on Senior Marketing Operations Specialist who will take the lead in executing and optimizing our marketing initiatives across international markets, with a particular emphasis on the APAC region. This pivotal role bridges global strategy with regional execution; you will collaborate with the central marketing operations team and work closely with international teams to localize, develop, and enhance marketing programs that drive customer growth, engagement, and retention across diverse markets.This position is ideal for someone who flourishes in a dynamic, cross-cultural environment and is adept at executing campaigns with precision to stimulate growth in international markets.Key Responsibilities:Campaign Execution & Operations Manage the complete process of building and deploying email and SMS campaigns supporting CLM initiatives across international markets, including batch sends and automated journeys. Additionally, collaborate with product teams to create localized in-product messaging. Build and QA dynamic templates using HTML/CSS and AMPscript; configure audience segments using data extensions, ensuring campaigns are tailored for regional audiences while adhering to local regulations.Regional Enablement & Collaboration Work closely with the APAC Regional Head and international marketing stakeholders to grasp regional priorities, campaign calendars, and audience nuances. Act as the operational link between global marketing infrastructure and regional execution needs, ensuring timely delivery of programs aligned with local market strategies.Journey Builder & Automation Configure and manage automated journeys in SFMC Journey Builder for essential CLM moments—onboarding, engagement, retention, win-back, and renewal—adapted for international audiences. Support the ongoing transition from Automation Studio to Journey Builder across international programs.Localization & Compliance Ensure all campaigns meet localization and compliance requirements across various regions to maintain effective audience engagement.

Xometry (NASDAQ: XMTR) is at the forefront of revolutionizing the manufacturing landscape by bridging innovative thinkers with manufacturers capable of turning their visions into reality. Our digital marketplace equips manufacturers with essential resources to expand their operations while providing Fortune 1000 companies seamless access to global manufacturing capabilities.In the role of Senior Sales Strategy & Operations Lead, you will collaborate closely with our Sales leadership team as a vital business partner. This prominent analytical position is dedicated to enhancing Xometry's revenue potential and optimizing sales efficiency. You will transition from tactical process management to defining our Go-to-Market (GTM) strategy, spearheading crucial planning cycles, and translating complex operational data into high-level executive recommendations.Your success will be evaluated based on your capacity to elevate sales effectiveness through strategic insights, thorough planning, and impeccable execution of organizational change initiatives. You will serve as the analytical and strategic cornerstone of the Sales Operations function.

About Us:Oruka Therapeutics (Nasdaq: ORKA) is at the forefront of developing innovative biologics that aim to revolutionize the treatment of chronic skin diseases. Our mission is to empower patients suffering from conditions like plaque psoriasis with unprecedented freedom from their ailments by achieving complete disease clearance with treatment regimens as infrequent as once or twice a year. We are advancing a proprietary portfolio of potentially best-in-class antibodies, engineered by Paragon Therapeutics, targeting the fundamental mechanisms behind plaque psoriasis and other dermatological and inflammatory disorders. For more detailed information, please visit www.orukatx.com.As we cultivate our core team, we are in search of exceptional talent across various functional areas—individuals who are not merely seeking a job but are enthusiastic about being part of a larger vision. We seek those who are passionate about making a meaningful impact and are eager to contribute to fostering an engaged, inclusive, and positive company culture.Role Overview:The Clinical Trial Manager/Senior Clinical Trial Manager will be responsible for ensuring compliance with trial protocols, regulatory requirements, and overall trial execution.

At Xometry (NASDAQ: XMTR), we are revolutionizing the manufacturing landscape by bridging the gap between innovative thinkers and the manufacturers who bring their visions to reality. Our cutting-edge digital marketplace equips manufacturers with essential resources to expand their operations while enabling Fortune 1000 companies to access a vast network of global manufacturing capabilities.We are looking for driven Mechanical Engineers to join our team as Technical Account Managers (TAMs). In this pivotal role, you will integrate within our key strategic accounts, working closely as an extension of their engineering teams. This position uniquely combines customer engagement, technical acumen, and operational execution. While you will report to Operations, your collaboration with Sales will be crucial in driving growth and ensuring exceptional customer satisfaction.This is a fantastic opportunity to become part of a vibrant and expanding firm at the forefront of digital manufacturing. If you are a passionate Mechanical Engineer eager to contribute to customer success and make a tangible impact, we invite you to apply.

We are seeking a detail-oriented and innovative Technical Writer to join our dynamic team at Collabera. In this role, you will be responsible for creating clear, concise, and user-friendly documentation that enhances understanding and usability for our products and services. You will collaborate with engineers, product managers, and other stakeholders to gather information and translate complex technical concepts into engaging content.