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Testing Lead (Hiring Immediately)
Guidehouse 3.7
Quality assurance manager job in Boston, MA
Job Family: Technology Consulting Travel Required: Up to 25% Clearance Required: None What You Will Do: The Testing Lead will serve as the overall owner of the testing program for the Commonwealth of Massachusetts statewide Oracle Health (Cerner) EHR implementation. This role is responsible for designing, executing, and validating a comprehensive testing strategy that spans all phases of the implementation lifecycle, including unit, system, integration, regression, and user acceptance testing. The Testing Lead will ensure that all workflowsclinical, financial, operational, and technicalare validated for safety, reliability, and compliance across DPH hospitals, DMH facilities, SOPS, and community-based services. Key Responsibilities Testing Strategy and Governance Develop and maintain the Master Test Plan, including scope, schedule, entry/exit criteria, traceability, and risk posture. Chair the Testing Governance Committee, escalating risks, defects, and go/no-go recommendations to the Steering Committee. Establish consistent application of methodology across all facilities and testing events. Provide executive-level reporting to EOHHS leadership on readiness, defect posture, and overall progress. Testing Execution and Oversight Lead all testing events including: Unit Testing: Validate build objects (orders, flowsheets, dictionaries, charge codes). Build Quality Audit (BQA): Confirm configuration accuracy and compliance with Oracle Health standards. System Testing: Validate end-to-end workflows within facilities. Integration Testing: Confirm HL7/FHIR message integrity across labs, imaging, MIIS, PBM claims, and SOPS Meta. Security Testing: Validate role-based access, HIPAA, and 42 CFR Part 2 compliance. Accessibility Testing: Confirm WCAG 2.1 AA standards for behavioral health and vulnerable populations. Charge and Claims Testing: Validate financial workflows and payer adjudication. Parallel Revenue Cycle Testing: Reconcile Oracle Health Patient Accounting with legacy MEDITECH systems. Data Migration Testing: Confirm completeness and accuracy of migrated data. Device Testing: Validate integration of bedside and ancillary devices. Performance and Stress Testing: Confirm system responsiveness and resilience. User Acceptance Testing (UAT): Validate real-world workflows with EOHHS super users. Post-Live Smoke Testing: Confirm core functions are stable immediately after cutover. Regression Testing: Ensure upgrades and patches do not disrupt validated workflows. Tools and Automation Manage automation frameworks using Oracle Health Test Studio, Tricentis Tosca, and interface replay harnesses. Prioritize automation for repetitive workflows (e.g., admit order MAR charge) to reduce burden on state staff. Maintain defect tracking in Jira/Confluence, with dashboards for aging, velocity, and closure trends. Use Smartsheet and Power BI for readiness dashboards and reporting. Environment and Data Management Maintain stable, synchronized testing environments across Waves 1 and 2. Manage test data creation, de-identification, and seeding. Coordinate with Oracle Health on environment refresh cycles and defect fix migrations. Stakeholder Engagement and Collaboration Collaborate with Domain Test Managers, Defect Manager, Automation Lead, and EOHHS champions. Facilitate daily stand-ups, defect triage sessions, and readiness reviews. Ensure EOHHS staff are engaged as validators, not burdened as primary testers. Document all testing decisions, results, and evidence in the Oracle Project Portal. Organizational Impact and Communication Leads cross-functional testing teams across clinical, financial, and technical domains. Communicates complex testing strategies to stakeholders at all levels. Ensures alignment with Commonwealths enterprise architecture and governance standards. Innovation and Complexity Designs scalable, compliant, and resilient testing architecture across diverse care settings. Navigates complex legacy environments and fragmented workflows. Applies structured, repeatable methodologies for high-risk testing domains. Leadership and Talent Management Manages domain test managers, automation engineers, defect analysts, and environment coordinators. Provides mentorship, performance feedback, and escalation support across all testing workstreams. Coordinates with PMO, Technical Lead, and Functional Leads to ensure delivery milestones are met. What You Will Need: Minimum 10 years of experience in healthcare IT testing, with at least 5 years in leadership roles. Proven experience with Oracle Health Millennium and RevElate testing frameworks. Deep understanding of EHR testing best practices, including parallel revenue cycle testing, EMPI validation, and integrated testing. Experience testing in public sector environments, including DPH, DMH, and SOPS workflows. Familiarity with HL7/FHIR standards, device integration, and interface validation. Strong knowledge of compliance testing (HIPAA, 42 CFR Part 2, ADA/Section 508). Expertise in testing governance, defect management, and automation tools. Excellent communication, stakeholder engagement, and documentation skills. What Would Be Nice To Have: Certifications in ISTQB, HIMSS, or Oracle Health testing tools. Experience with federal/state EHR implementations, including VA or DoD projects. Familiarity with Oracle Cloud Infrastructure (OCI) and hybrid hosting models. Experience with behavioral health, correctional, and long-term care testing scenarios. The annual salary range for this position is $130,000.00-$216,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs. What We Offer: Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace. Benefits include: Medical, Rx, Dental & Vision Insurance Personal and Family Sick Time & Company Paid Holidays Position may be eligible for a discretionary variable incentive bonus Parental Leave and Adoption Assistance 401(k) Retirement Plan Basic Life & Supplemental Life Health Savings Account, Dental/Vision & Dependent Care Flexible Spending Accounts Short-Term & Long-Term Disability Student Loan PayDown Tuition Reimbursement, Personal Development & Learning Opportunities Skills Development & Certifications Employee Referral Program Corporate Sponsored Events & Community Outreach Emergency Back-Up Childcare Program Mobility Stipend About Guidehouse Guidehouse is an Equal Opportunity EmployerProtected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation. Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco. If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at ************** or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation. All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @guidehouse.com or ************************. Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse. Note that Guidehouse will never charge a fee or require a money transfer at any stage of the recruitment process and does not collect fees from educational institutions for participation in a recruitment event. Never provide y
$130k-216k yearly 1d ago

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US/LATAM Spanish LQL Linguistic Quality Lead
Csoft International
Quality assurance manager job in Boston, MA
Schedule: Mon-Fri (4 days in office required, 1 day optional remote) Compensation: Competitive Salary + Benefits We are a fast-growing AI language technology company seeking a US/LATAM Spanish Linguistic Quality Lead (LQL) to join our AI-focused language team on a mission to build the next generation of operational models. This is a unique opportunity for someone passionate about languages and technology, with the drive to shape the future of AI-powered communication in medical and life sciences translation. What You'll Do Lead linguistic quality assurance for US/LATAM Spanish, with a strong focus on medical device manuals, pharmaceutical content, and other regulated life sciences materials. Train large language models (LLMs) with Spanish linguistic data to enhance AI-driven translation, QA, and automation workflows. Translate, review, and edit Spanish content in active projects, ensuring accuracy, clarity, and regulatory compliance. Recruit, onboard, and manage Spanish linguistic resources (translators, editors, interpreters, interviewers) within our global network. Support project execution, ensuring linguistic excellence and cultural relevance across deliverables. Collaborate with other LQLs to drive workflow improvements and innovation, helping design future operational models. Partner with cross-functional teams at the intersection of language, life sciences, and AI. What We're Looking For Native proficiency in US/LATAM Spanish, with strong command of English. Ideal for your graduates with Spanish linguistic background. Familiarity with CAT tools (e.g., Phrase, Trados, MemoQ, XTM) is a plus but not required. Forward-thinking, creative, and energetic, with a willingness to take on challenges and think outside the box. Diligent, dependable, and committed to quality and continuous improvement. Strong organizational, communication, and problem-solving skills. Ability to work collaboratively with other LQLs, engineers, and project teams in a fast-paced, innovative environment. Work authorization in the U.S. is required. What We Offer Full-time role: Monday-Friday, with 4 days in-office and 1 day optional remote. Competitive salary + paid holidays, sick/personal days, and professional development opportunities. A modern office in Boston's Financial District. The chance to contribute to an AI-driven language team pioneering future business and operational models. A dynamic, entrepreneurial environment where your ideas and contributions have direct impact. This is an exciting role for someone passionate about Spanish language and culture, eager to explore AI-powered translation and linguistic innovation, and motivated to grow with a company shaping the future of language operations in medical and life sciences. How to Apply: Please send your CV to **********************
$88k-131k yearly est. 19h ago
Director, R&D Quality Governance & Risk
Vertex Pharmaceuticals 4.6
Quality assurance manager job in Boston, MA
A global biotechnology company is seeking a Director of R&D Quality Governance & Risk Management to lead and enhance the governance framework supporting risk-based decisions. This strategic role requires 10+ years of R&D QA experience, strong leadership presence, and operational agility. Candidates should possess exceptional collaboration skills and mentorship capabilities. The role offers flexibility in a hybrid work environment with competitive compensation and comprehensive benefits. #J-18808-Ljbffr
$141k-181k yearly est. 4d ago
Bioconjugation Quality Assurance Supervisor
Veranova
Quality assurance manager job in Devens, MA
Discover Veranova: At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference. Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation. Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients. Role Overview: This role provides Quality Assurance (QA) support for bioconjugation processes and GMP manufacturing of APIs and intermediates, ensuring compliance with global quality standards and regulatory requirements. This role will oversee key quality activities including deviation management, change control, batch record review, and product disposition, while driving continuous improvement and compliance initiatives. As a leader within the Quality Operations team, the QA Supervisor will guide and develop team members, collaborate across functions, and shape the strategic direction of quality within the organization. Core Responsibilities: Lead Quality Assurance oversight for bioconjugation manufacturing, ensuring GMP production and release of conjugated APIs, linkers, and payloads meet client expectations, timelines, and quality standards. Provide hands-on QA support on the production floor during conjugation, purification, and filling operations to ensure compliance with cGMPs, SOPs, and company policies. Oversee the review and approval of deviations, change controls, CAPAs, batch records, specifications, and other controlled quality documentation. Coach, mentor, and develop QA staff, providing guidance on quality systems, compliance practices, and real-time problem solving. Drive operational excellence by aligning local QA initiatives with global objectives and promoting a culture of quality and compliance across the organization. Support audits, investigations, and regulatory inspections, ensuring timely follow-up and continuous improvement in processes and systems. Evaluate complex quality or cross-functional issues using a risk-based approach and ensure CDMO partners meet Quality Agreement and regulatory expectations. Prioritize and allocate QA resources effectively to meet business demands and production schedules. Serve as a key client interface for Quality topics, fostering strong relationships and clear communication on regulatory and quality matters. Contribute to organizational quality strategy by participating in forums, continuous improvement initiatives, and talent development efforts. Qualifications: Required Minimum 9 years of quality assurance (QA) experience in a GMP manufacturing setting, preferably within a CDMO or API/intermediate facility, with an undergraduate degree in engineering, science or related field; or a minimum 7 years of QA experience with a graduate degree in engineering, science or related field Proven leadership experience in pharmaceutical, API/intermediate, medical device, biologics or related FDA industry Demonstrated proficiency and knowledge of cGMP, ICH, and other US and worldwide regulatory requirements Working knowledge of US & EU GMP, ICH Q7 and Part 11 compliance Proven ability to drive complex projects from initiation to completion, with strong analytical, problem-solving, and attention-to-detail skills. Demonstrated experience working effectively both independently and in team settings, including prior people management or team leadership. Excellent communication, interpersonal, networking, presentation, and influencing skills to build and lead cross-functional relationships. Embodies and promotes Veranova's culture, fostering an inclusive, positive work environment and delivering exceptional business results. Strong collaborative mindset with the ability to motivate, develop, and inspire others while effectively managing priorities and responsibilities. Preferred Direct experience with bioconjugation processes (e.g., linker/payload attachment, conjugated intermediates) is strongly preferred. Familiarity with HPAPI handling and containment requirements a plus Certified Lead Auditor certificate, or certification(s) in Lean manufacturing methods/tools such as structured problem solving, Lean Six Sigma, etc. Salary Range: $125,000 - $140,000 annual base salary Our Commitment: Health & Wellness: Comprehensive health & wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies. Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors. Final compensation may vary depending on experience, skills, education, and business needs. Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs. Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We welcome people with diverse experiences and perspectives who share our mission to improve and save lives. Even if you don't meet every qualification, we encourage you to apply. Veterans, first responders, and those transitioning from military to civilian life bring valuable skills that strengthen our team. Additional Information: Applicants for this role must be authorized to work in the United States without further employer sponsorship. Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting. All your information will be kept confidential according to EEO guidelines. Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law. All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice .
$125k-140k yearly 2d ago
Quality Systems & Investigations Specialist
JMD Technologies Inc.
Quality assurance manager job in Boston, MA
Title: Quality Systems & Investigations Specialist Employment Type: Contract Status: Accepting Candidates About the role This position plays a key role in supporting daily manufacturing activities by resolving operational issues and driving high-quality investigations. The role ensures process reliability through strong technical oversight and collaboration with critical operations teams. Key Responsibilities • Lead real-time floor support, triaging deviations and initiating root cause investigations. • Produce thorough, compliant quality documentation for deviations, CAPAs, and impact assessments. • Partner with manufacturing, QC, facilities, and materials teams to define corrective and preventive actions. • Apply structured scientific thinking to evaluate data and support operational decisions. • Contribute to process improvement by identifying trends and proposing optimized workflows. Qualifications • 6+ years experience in pharma/biotech manufacturing environments. • Proven background in investigations, RCA, QC analytics, and GxP documentation. • Skilled in cross-functional coordination and rapid issue assessment. • Strong analytical mindset with the ability to interpret complex data sets. • Experience supporting manufacturing operations in fast-paced, regulated environments. Compensation (MA Pay Transparency): • Estimated hourly range: $50-$58/hr (W-2). • Final rate within this range will be based on skills, experience, and interview results.
$50-58 hourly 3d ago
Quality Assurance Manager - Food Safety
LSG Sky Chefs 4.0
Quality assurance manager job in Boston, MA
Job Title: Quality Assurance Manager - Food Safety Salary Range: $90 000.00 About us LSG Sky Chefs is one of the world's largest airline catering and hospitality providers, known for its outstanding reputation and dynamic approach in the industry. Voted "Airline Caterer of the Year in North America" for 2023 and 2024, we are committed to excellence and innovation, driven by the dedication and expertise of our talented employees. Our team members are the heart and soul of our success, consistently delivering exceptional culinary experiences and outstanding service to our clients and their passengers across North and Latin America. Role Purpose Statement Ensure the food meets the standards set by regulatory health authorities and the company. The job incumbent is responsible for the implementation, auditing, assessing and training of food safety and quality management systems within the responsible Customer Service Center (CSC). Responsible for the development, deployment, implementation, and on-going execution of the food safety preventive controls program (Policies, SOPs, Hazard Analysis, HACCP Plan, Prerequisite Food Safety Programs, Traceability & Recall Process, Allergen Programs, and Associated Records) within the assigned facility. Main Accountabilities Ensure compliance with regulatory requirements Food and Drug Administration (FDA) such as federal regulation, local regulation, United States Department of Agriculture (USDA), customer specifications and corporate food safety and quality standards, regional food safety and quality standards, taken appropriate corrective actions when needed. Manage the food safety program and ensures that FDA FSMA preventive controls are effective and proper records are maintained. Provide technical expertise relative to Hazard Analysis and Critical Control Points (HACCP), food safety, sensory and quality evaluations. Conduct monthly-required assessments of the food safety program to ensure compliance. Conduct routine microbiological testing as defined by food safety program. Review and analyse weekly food safety documents including HACCP logs. Utilization of the checklists to determine consistent fulfilment of required food safety program. Support CSC leadership with inspection/audit readiness; coach CSC before, during and after all external, food safety, quality and sanitation inspections/audit. Supervise pest control program and contract services and suppliers related to the food safety program. Conduct appropriate investigations regarding food safety matters and support CSC management in providing detailed information to the customers. Perform and document periodical checks on products and services to ensure quality standards are met. Interface with functional areas (Operations, Production, Sales, and HR), Regional Quality Team, other quality managers to ensure sustainability of the food safety program. Establish and maintain effective working relationships with internal stakeholders across all functions and suppliers, customers and regulatory authorities. Reporting Monitor and prepare reports for the food safety and quality management system. Insertion of monthly-required data in the company web based portal. Collect and monitor all food safety and quality documents (e.g. environmental monitoring, sanitation verifications, chef table, portion control, equipment handling, ramp-on time and safety performance) Keep manuals and documentation updated and implement new procedures and rules in a timely manner. Leadership Possess excellent verbal and written communication skills, including the ability to communicate professionally in person, by phone and through email. Must be able to work in a fast-paced environment while interacting with staff at all levels, and remaining positive, proactive and resourceful. Demonstrates initiative and the ability to work efficiently and independently. Able to read and understand food safety and quality reports and take appropriate action. Must possess a high level of accuracy, attention to detail and is well organized. Recruit, on-board, develop, coach, train, support, and evaluate the performance of the Food Safety staff. Participate and support company sponsored initiatives such as Global Quality Standards (GQS), HACCP, Lean Manufacturing, Employee Safety Knowledge, Skills and Experience Bachelor's degree in Food Science, Food Microbiology, Chemistry, Biology or related fields. Certified Preventive Controls Qualified Individual (PCQI) and Hazard Analysis Critical Control Points (HACCP) Five or more years of experience in Food Safety roles with a minimum of 2 years management experience. Technical proficiency in the areas such as of food microbiology, food chemistry, food safety, and food regulations. Proven understanding of government regulations in relation to food processing as FDA FSMA, Current Good Manufacturing Practices (cGMP), HACCP regulations and USDA. Proven analytical and leadership skills. Strong interpersonal and communication skills. Be a collaborative leader who inspires, manages, coaches and respects people. Excellent verbal, written and organizational skills that combines with an aptitude for multi-tasking. Knowledge of computer skills required, including use of technology (scanners, tablets, printers, copiers, etc.) and Microsoft Office programs, as well as cloud based systems LSG Sky Chefs is an EEO and Affirmative Action Employer of Women/Minorities/Veterans/Individuals with Disabilities.
$90k yearly 17h ago
Quality Systems Specialist
Advantage Technical
Quality assurance manager job in Waltham, MA
Pay Rate: $40-$50/hr Work Model: Hybrid (Onsite Tuesday, Wednesday, Thursday) The Quality Systems Specialist, under the direction of the QS&C management team, supports global Quality Systems to ensure compliance, operational effectiveness, and fitness for intended use in alignment with applicable global SOPs. Key Areas of Accountability Quality System Governance & Support Assist in governance of Quality System applications, including harmonizing processes across sites Participate in meetings/workshops with Site Process Owners and business SMEs to gather requirements for system improvements and ongoing maintenance Join user forums to collect ongoing requirements, prioritize needs, and triage issues Follow up on requests, issues, and project activities; provide status updates to managers and working teams Change Control & Compliance Initiate and manage change controls through completion, including all required documentation Ensure systems remain in a validated state by supporting periodic user access reviews, change management, business administration, and deviations/CAPAs Support investigation, escalation, and resolution of system-related issues Validation & Documentation Support validation activities, including: Requirements gathering Validation planning Design qualification Authoring and executing test plans and test scripts Discrepancy management Preparing system descriptions and validation summary reports Maintain user-related documentation and ensure updates as new functionalities are introduced Cross-Functional & User Support Assist manager with communication between vendor/IT teams Provide customer support through system administration, training management, and onboarding of new users Generate metrics to support Quality Systems performance Support regular system updates/releases and provide assessments and recommendations on new features Academic & Technical Qualifications Bachelor's degree or higher in a relevant computer, technical, quality, or scientific discipline (multi‑disciplinary background preferred) 3-6 years of experience in a high‑volume commercial or clinical pharma/healthcare environment Proficiency in MS Word, Excel, and Quality System processes Experience with Veeva Vault Quality Docs, TrackWise, and ComplianceWire is a plus Strong understanding of US FDA and European regulatory requirements, GAMP, and phase‑appropriate compliance expectations Knowledge of Regulatory Compliance and ICH Guidelines General Comments Position Title: Quality Systems Specialist Pay Rate Range: $40-$50/hr
$40-50 hourly 19h ago
Director, GMP QA
Genmab
Quality assurance manager job in Grafton, MA
At Genmab, we are dedicated to building extra[not]ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! The Role Genmab is seeking an experienced and strategically oriented QA Director for Chemical Intermediates (CI), Biological Intermediates (BI), and Drug Substance (DS) to lead Quality Assurance oversight of CI, BI, and DS activities supporting commercial products, all manufactured through external partners. This role plays a critical part in safeguarding product quality, patient safety, and supply reliability in a fully outsourced manufacturing model. In addition, the role carries responsibility for building and scaling a fit-for-purpose QA organization for CI, BI, and DS over the coming years, aligned with the expansion of Genmab's commercial portfolio and global CMO network. You will be part of the global GMP QA organization and a key member of the QA leadership team, reporting directly to the Team Lead of QA GMP Commercial. Key Responsibilities The responsibilities of the QA Director for CI / BI / DS will include, but not be limited to: Define and drive the QA strategy for CI, BI, and DS supporting commercial products in a fully outsourced manufacturing model. Provide end-to-end QA oversight of commercial CI, BI, and DS manufacturing activities at CMOs, ensuring sustained GMP compliance and supply continuity. Hold overall responsibility for QA release of CI, BI, and DS, including establishment of release strategies, governance, and escalation pathways. Ensure robust review and approval of batch documentation and manufacturing data supporting release decisions, in accordance with Genmab's Pharmaceutical Quality System. Build, scale, and develop the CI / BI / DS QA organization, including defining future capabilities, roles, and competencies in line with business growth. Lead, mentor, and develop a growing QA team, fostering a strong quality culture and ensuring succession and knowledge management. Establish and maintain robust quality agreements and governance models with CMOs, ensuring clear accountability and escalation pathways. Oversee deviations, CAPAs, change controls, and risk assessments related to commercial CI, BI, and DS manufacturing. Ensure QA oversight of continued process verification, ongoing validation, and lifecycle management for commercial processes. Drive inspection readiness and lead QA support for regulatory inspections at CMOs, including routine and for-cause inspections. Plan, perform, and follow up on audits of CMOs and critical suppliers supporting commercial manufacturing. Provide QA input to regulatory submissions, variations, and post-approval changes related to CI, BI, and DS. Act as a key QA interface to Supply Chain, proactively identifying and mitigating quality-related risks to commercial supply. Contribute to continuous improvement of Genmab's Pharmaceutical Quality System with focus on commercial operations and outsourced manufacturing. What We Are Looking For You hold a MSc degree in life science. Minimum 10 years of experience within the pharmaceutical industry, with extensive GMP QA experience supporting commercial CI, BI, and/or Drug Substance manufacturing at CMOs. Proven experience building and scaling QA teams in response to business growth and increasing complexity. Strong understanding of biologics manufacturing (e.g. monoclonal antibodies) and associated intermediates; experience with chemical intermediates is an advantage. Demonstrated experience with commercial-stage CMO oversight, quality agreements, audits, and regulatory inspections. Strong people leadership and organizational design capabilities. Solid knowledge of global GMP and ICH requirements and post-approval lifecycle management. Comfortable operating in a high-complexity, supply-critical environment. Excellent English communication skills and a pragmatic, risk-based QA mindset. What You'll Gain A QA leadership role with direct impact on commercial product quality, patient safety, and supply reliability. The opportunity to build and mature a scalable QA organization supporting a growing commercial portfolio. A role combining long-term strategic ownership with hands-on engagement in complex, supply-critical manufacturing activities. A collaborative, performance-driven culture that values quality, accountability, and continuous improvement. About You You are genuinely passionate about our purpose You bring precision and excellence to all that you do You believe in our rooted-in-science approach to problem-solving You are a generous collaborator who can work in teams with a broad spectrum of backgrounds You take pride in enabling the best work of others on the team You can grapple with the unknown and be innovative You have experience working in a fast-growing, dynamic company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so! Locations Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO ) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).
$112k-161k yearly est. 1d ago
Principal Engineer, AI-Driven Data QC & Reporting
The Association of Technology, Management and Applied Engineering
Quality assurance manager job in Boston, MA
A leading biotechnology company in Boston is looking for a Principal Engineer to lead automation of the data QC and reporting processes. The ideal candidate will have extensive experience in technical leadership, particularly in the biotechnology sector, with advanced programming skills in R and Python. Responsibilities include developing modernization initiatives and leveraging AI solutions to improve data management and reporting standards. This position allows for a hybrid work model, requiring up to 10% travel. #J-18808-Ljbffr
$98k-127k yearly est. 19h ago
Quality Engineer I/II
Vaxess Technologies
Quality assurance manager job in Woburn, MA
Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess' patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world. The Role: The Quality Engineer I / II will support Quality Assurance activities for Vaxess' combination product programs, with a strong focus on medical device design controls, risk management, and cGMP compliance. This role provides hands-on quality support across design and development, supplier oversight, process validation readiness, and batch record/data review, aligned with ISO 13485, 21 CFR 820, and applicable combination product regulations (21 CFR 4). Reporting to the Quality Assurance Manager, this role works cross-functionally with Manufacturing, Process Development, Quality Control, and Material Management to support compliant execution and ensure product quality and safety during early clinical development. Responsibilities: Support quality oversight of Vaxess combination product(s) to ensure compliance with safety, efficacy, and regulatory requirements. Administer and support the Quality Management System (QMS) in accordance with ISO 13485, 21 CFR 820, 21 CFR Part 4 (Combination Products), and applicable FDA and international regulations. Provide quality support for Design Control activities, including Design History File (DHF) maintenance, design reviews, Design Verification and Validation (DVV), and design changes. Support risk management activities, including development and maintenance of risk analyses (e.g., FMEA, hazard analyses) and linkage to design and process controls. Support process validation and qualification activities, including test method validation (TMV), process validation (PV), and equipment qualification, as applicable to Phase I and GMP-ready manufacturing. Participate in Material Review Board (MRB) activities, including nonconformance assessment, disposition, and documentation. Perform quality review and approval of batch records, executed manufacturing records, analytical data collection forms, test records, and technical or experimental reports. Collaborate in supplier quality management activities, including supplier qualification, auditing, monitoring, change evaluation, and periodic requalification. Author, review, and revise quality documentation, including SOPs, work instructions, test methods, protocols, reports, forms, and specifications. Support preparation, review, and organization of quality data and documentation for regulatory submissions and inspections. Contribute to continuous improvement initiatives within the QMS, including CAPA, deviation investigations, and quality metrics. Qualifications: Quality Engineer I: Minimum of 3 years of experience in Quality Assurance or Quality Engineering within a cGMP-regulated medical device or combination product environment. Quality Engineer II: Typically 4-5 years of progressive quality experience in medical devices, pharmaceuticals, biologics, or combination products. Working knowledge of ISO 13485 and FDA medical device Quality System Regulations (21 CFR 820); familiarity with combination product requirements strongly preferred. Experience supporting early-phase (preclinical to Phase I) product development is highly desirable. Experience with design controls, risk management (FMEA), and validation activities preferred. Experience reviewing GMP documentation such as batch records, test methods, protocols, and reports. Strong written and verbal communication skills, with the ability to clearly document technical and quality concepts. Proficiency with Microsoft Office applications (Word, Excel, PowerPoint). At Vaxess, we're bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to ****************** .
$80k-104k yearly est. 1d ago
Aerospace & Defense Quality Engineer
Biotalent
Quality assurance manager job in Newburyport, MA
Aerospace & Defense Quality Engineer - 6-Month Contract The Quality Engineer will be responsible for the development, implementation, maintenance, and continuous improvement of quality assurance processes in a regulated aerospace and defense environment. This role requires a strong data-driven mindset and hands-on quality engineering expertise to ensure compliance with AS9100/ISO standards, customer requirements, and regulatory obligations. Responsibilities Identify, analyze, and resolve quality issues using structured problem-solving methodologies Perform loss reporting and drive continuous improvement initiatives Design and implement process control, process improvement, testing, and inspection methods Develop, execute, and analyze quality metrics and reporting to support data-driven decision-making Perform and review First Article Inspections (FAI) in accordance with AS9102 requirements Interpret and apply GD&T per ASME Y14.5 to support inspection planning, nonconformance resolution, and root cause analysis Ensure compliance with AS9100 and applicable ISO standards across manufacturing and inspection processes Support and participate in internal, customer, and third-party quality audits Collaborate cross-functionally with engineering, manufacturing, and supply chain teams to ensure quality requirements are met throughout the product lifecycle Qualifications Bachelor's degree in Mechanical, Electrical, Manufacturing Engineering, or a related field (or equivalent experience) 4+ years of quality engineering experience in aerospace, defense, or another regulated manufacturing environment Strong working knowledge of AS9100, ISO 9001, and aerospace quality system requirements Experience performing and reviewing First Article Inspections (AS9102) Proficiency in interpreting engineering drawings and GD&T per ASME Y14.5 Strong knowledge of industry quality tools (e.g., SPC, FMEA, root cause analysis, CAPA) Demonstrated analytical, data-driven approach to problem solving Strong communication, documentation, and audit-support skills To learn more or apply, please contact me at ****************************. BioTalent Ltd is acting as an employment agency in relation to this opportunity.
$79k-104k yearly est. 2d ago
Quality/Regulatory Manager
Analog Devices 4.6
Quality assurance manager job in Wilmington, MA
Analog Devices, Inc. (NASDAQ: ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world. With revenue of more than $9 billion in FY24 and approximately 24,000 people globally, ADI ensures today's innovators stay Ahead of What's Possible™. Learn more at ************** and on LinkedIn and Twitter (X). Job Description: Quality and Regulatory Manager Job Title: RA/QA Manager Location: US-based , Wilmington, MA (remote will be considered) Function: Regulatory and Quality Reports to: Business Lead Analog Devices, Inc. (NASDAQ: ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world. With revenue of more than $9 billion in FY24 and approximately 24,000 people globally, ADI ensures today's innovators stay Ahead of What's Possible™. Learn more at ************** and on LinkedIn and Twitter (X). You will be working within a small, stealth group of talented individuals at ADI focused on next-generation technologies solving some of the world's toughest problems around human and planetary health. We are seeking an experienced and highly motivated Quality and Regulatory Manager to lead the development, implementation, and maintenance of our Quality Management System (QMS) and oversee regulatory submissions for medical devices and life science products. The ideal candidate will have proven expertise in U.S. FDA regulatory submissions, including successful 510(k) approvals, and will ensure compliance with applicable domestic and international regulations. Key Responsibilities Develop, implement, and maintain a comprehensive Quality Management System (QMS) aligned with ISO 13485, FDA QSR, and other applicable regulations. Lead the preparation, submission, and maintenance of regulatory submissions including FDA 510(k), CE Mark Technical Files, and international registrations. Ensure company-wide compliance with all relevant quality and regulatory standards. Manage internal and external audits, inspections, and corrective/preventive actions (CAPA). Provide regulatory strategy and guidance to cross-functional teams during product development and commercialization. Establish and maintain policies, procedures, and training programs to support quality and regulatory compliance. Monitor changes in global regulatory requirements and advise management on their potential impact. Serve as the primary liaison with regulatory agencies and notified bodies. Lead risk management activities and ensure compliance with ISO 14971 requirements. Support post-market surveillance activities, including complaint handling and adverse event reporting. Qualifications and Experience Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or related field (Master's preferred). Minimum of 10 years of progressive experience in quality and regulatory roles within the medical device or life sciences industry. Proven track record of successful FDA 510(k) submissions and approvals. Strong knowledge of ISO 13485, FDA QSR, ISO 14971, MDR, and other relevant regulatory frameworks. Experience managing QMS development, implementation, and continuous improvement. Demonstrated ability to interface effectively with regulatory bodies, auditors, and internal teams. Excellent organizational, leadership, and communication skills. Ability to work independently and collaboratively in a fast-paced environment. For positions requiring access to technical data, Analog Devices, Inc. may have to obtain export licensing approval from the U.S. Department of Commerce - Bureau of Industry and Security and/or the U.S. Department of State - Directorate of Defense Trade Controls. As such, applicants for this position - except US Citizens, US Permanent Residents, and protected individuals as defined by 8 U.S.C. 1324b(a)(3) - may have to go through an export licensing review process. Analog Devices is an equal opportunity employer. We foster a culture where everyone has an opportunity to succeed regardless of their race, color, religion, age, ancestry, national origin, social or ethnic origin, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, parental status, disability, medical condition, genetic information, military or veteran status, union membership, and political affiliation, or any other legally protected group. EEO is the Law: Notice of Applicant Rights Under the Law. Job Req Type: ExperiencedRequired Travel: Yes, 10% of the time Shift Type: 1st Shift/DaysThe expected wage range for a new hire into this position is $106,500 to $159,750. Actual wage offered may vary depending on work location, experience, education, training, external market data, internal pay equity, or other bona fide factors. This position qualifies for a discretionary performance-based bonus which is based on personal and company factors. This position includes medical, vision and dental coverage, 401k, paid vacation, holidays, and sick time, and other benefits.
$106.5k-159.8k yearly Auto-Apply 3d ago
Director, Regulatory Affairs and Quality Assurance
Whoop 4.0
Quality assurance manager job in Boston, MA
WHOOP is an advanced health and fitness wearable on a mission to unlock human performance and healthspan. We empower our members to improve their health and perform at a higher level through a deeper understanding of their bodies and daily lives. As the Director of Regulatory Affairs & Quality Assurance (RA/QA), you will lead the strategy, execution, and continuous evolution of WHOOP's regulatory and quality frameworks as we expand deeper into regulated digital health and medical-grade product capabilities. You will also play a critical role in strengthening WHOOP's design quality discipline, ensuring robust design controls, risk management, and design quality practices. You will shape the regulatory pathway for our next generation of health features, ensure compliance across global markets, and build systems that enable WHOOP to scale medical device development responsibly and efficiently. This role is ideal for a seasoned RA/QA leader who thrives in fast-paced, cross-functional environments and is motivated by the opportunity to help define the future of WHOOP as a health technology company. QUALIFICATIONS: * Lead regulatory strategy for WHOOP's health features and regulated products from development through approval and lifecycle management. * Oversee regulatory submissions including 510(k), De Novo, technical files, global registrations, providing strategic direction, final review, and cross-functional alignment. * Serve as WHOOP's primary liaison with regulatory agencies and notified bodies. * Interpret and communicate regulatory requirements to cross-functional teams, ensuring seamless integration throughout the development lifecycle. * Oversee WHOOP's Quality Management System (QMS) to ensure compliance with FDA, ISO 13485, MDR, and other global regulatory frameworks. * Provide leadership and oversight for Design Quality Engineers responsible for DHF maintenance, design reviews, risk management (ISO 14971), verification/validation strategy, and software change control processes. * Lead internal and external audit readiness, including FDA inspections and notified body audits. * Manage post-market surveillance and adverse event reporting. * Review marketing and promotional materials for regulated and general wellness features to ensure compliance. * Build, manage, and mentor a high-performing team. * Monitor regulatory changes, evolving standards, and industry trends, advising leadership on implications and opportunities. RESPONSIBILITIES: * Bachelor's degree in life sciences, engineering, regulatory affairs, or a related field; advanced degree preferred. * 8+ years of regulatory affairs experience in medical devices, digital health, wearables, or related fields. * Proven experience leading successful FDA submissions (510(k), De Novo) and managing global regulatory approvals. * Demonstrated success building or overseeing a Quality Management System, including experience with external audits. * Deep understanding of software as a medical device (SaMD), cybersecurity considerations, post-market requirements, and applicable standards. * Strong working knowledge of ISO 14971 risk management, including hazard analysis, FMEAs, risk/benefit justification, and integration of risk controls across hardware, firmware, and software. * Experience overseeing post-market quality activities, including complaints, MDR/Vigilance assessments, field actions, and design updates based on post-market signals. * Working knowledge of privacy and data regulations such as HIPAA and GDPR. * Exceptional communication, leadership, and stakeholder management skills. * Ability to thrive in a fast-paced, high-growth environment with evolving priorities. * Experience navigating the boundary between general wellness and SaMD, including evaluating feature intent, regulatory risk, and appropriate evidence pathways. It is strongly preferred that the candidate is able to work out of the WHOOP office located in Boston, MA. Interested in the role, but don't meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply. WHOOP is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. The WHOOP compensation philosophy is designed to attract, motivate, and retain exceptional talent by offering competitive base salaries, meaningful equity, and consistent pay practices that reflect our mission and core values. At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company's long-term growth and success. The U.S. base salary range for this full-time position is $220,000-$245,000. Salary ranges are determined by role, level, and location. Within each range, individual pay is based on factors such as job-related skills, experience, performance, and relevant education or training. In addition to the base salary, the successful candidate will also receive benefits and a generous equity package. These ranges may be modified in the future to reflect evolving market conditions and organizational needs. While most offers will typically fall toward the starting point of the range, total compensation will depend on the candidate's specific qualifications, expertise, and alignment with the role's requirements. Learn more about WHOOP.
$220k-245k yearly 47d ago
Director, Clinical Quality Assurance
Eisai Us 4.8
Quality assurance manager job in Boston, MA
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH). Essential Functions * Independently conduct audits * Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits * Facilitate Sponsor health authority inspections of global clinical facilities and study sites * Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs * Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies. * May be responsible for direct people management including goal setting, performance management, development, and engagement. Requirements * Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. * 5+ years of experience in GCP auditing. * Substantial experience in inspection management. * Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials. * Demonstrated ability to operate and influence decision-making processes * Effective communication skills * Successful track record of supervising employees and managing cross-cultural differences * Technical and administrative capabilities to independently carry out routine, complex and for-cause audits * Knowledge of data integrity controls and systems quality for clinical area * Strong analytical skills and report writing skills * Experience with GxP systems including computer system validation and associated regulations, recommended. * Ability to Travel (approximately 20%) * Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities. Eisai Salary Transparency Language: The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit *********************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation
$116k-159k yearly est. Auto-Apply 60d+ ago
Clinical Quality Program Manager
Mass General Brigham
Quality assurance manager job in Somerville, MA
Site: Mass General Brigham Health Plan Holding Company, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary Responsible for overseeing and improving clinical performance metrics and ensuring compliance with healthcare regulations and accreditation standards. Collaborates with clinical teams to develop strategies for improving patient care outcomes and ensures that clinical operations align with regulatory and quality requirements. Essential Functions -Monitor and analyze clinical performance data to identify areas for improvement in patient care and outcomes. -Ensure compliance with all regulatory, accreditation, and quality standards across clinical operations. -Collaborate with clinical staff to implement performance improvement initiatives and ensure best practices in patient care. -Develop and maintain clinical performance dashboards and reports to track key metrics. -Coordinate with quality, compliance, and risk management teams to ensure alignment with organizational goals. -Provide training and education to clinical teams on performance improvement, regulatory compliance, and accreditation standards. -Conduct audits and assessments of clinical processes to ensure continuous quality improvement. -Work with leadership to set performance goals and develop action plans to achieve them. Qualifications Education Bachelor's Degree required; work experience can be substituted in lieu of a degree License/Certification Massachusetts Registered Nurse (RN) license highly preferred Experience At least 3-5 years of experience in clinical performance management, compliance, or quality improvement required Knowledge, Skills, and Abilities Knowledge of healthcare regulations, accreditation standards (e.g., Joint Commission), and clinical performance metrics. Strong analytical skills with the ability to interpret clinical data and identify improvement opportunities. Excellent communication and collaboration skills to work effectively with clinical teams and leadership. Detail-oriented with a strong understanding of healthcare regulations and accreditation standards. Proficiency in performance management software and tools for tracking clinical outcomes. Ability to lead performance improvement projects and implement evidence-based practices. Additional Job Details (if applicable) Working Conditions This is a remote role that can be done from most US states Remote Type Remote Work Location 399 Revolution Drive Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $78,000.00 - $113,453.60/Annual Grade 7 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: Mass General Brigham Health Plan Holding Company, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
$78k-113.5k yearly Auto-Apply 29d ago
Construction Quality Control Manager
Dew Construction Corporation 3.6
Quality assurance manager job in Manchester, NH
We are looking for an experienced Construction Quality Control Manager to join our team. This role is responsible for developing, implementing, and managing quality control systems to ensure that construction activities and outputs comply with project specifications, company standards, and regulatory requirements. This role is critical in ensuring the delivery of high-quality of DEW Construction's projects through oversight, inspection, and coordination with project teams, subcontractors, and third-party inspectors. DEW's Vision, Mission, and Core Values: * Vision Statement: To be the go-to construction partner known for our unwavering commitment to the success of every project. * Mission Statement: To build a team of professionals who share our core values and foster a culture where everyone can thrive and grow together. * Core Values: * Optimism: We share a positive mindset, believing in opportunities over obstacles. * Initiative: We are self-motivated, proactive problem solvers. * Accountability: We are committed to a culture of ownership, personal accountability, and safety. DEW's Vision, Mission, and Core Values are explicitly integrated into our daily decision-making, leadership behaviors, employee training, performance evaluations, and company culture. We use them as a guiding principle for all activities and hold employees accountable for upholding them, essentially making them a tangible part of the company's identity and operations. Our aim is to ensure we are aware of these guiding principles and feel motivated and encouraged to continue integrating them into our daily lives Essential Functions: * Quality Assurance Program Development: * Develop and maintain project-specific Quality Control Plans (QCPs). * Ensure construction compliance with applicable project documents (Plans, Specifications, submittals, standards, regulations, and customer requirements. * Lead quality meetings and contribute to project pre-construction planning efforts. * Inspection and Testing: * Oversight and documentation of inspections, materials, workmanship, and final products. * Coordinate and document third-party testing and special inspections. * Identify and correct deficiencies with the project team utilizing Procore Observations to document deficiencies and non-compliant work as well as corrective action plans. * Documentation and Reporting: * Maintain detailed and organized quality records, including inspection logs, test reports, and compliance certifications. * Prepare and submit daily quality reports and project QA/QC status updates. * Review and approve subcontractor and supplier quality documentation. * Team Leadership and Communication: * Serve as the primary point of contact for quality control matters on the job sites for the Project Teams. * Train and mentor construction staff and subcontractors on quality standards and procedures. * Facilitate communication between project management, clients, regulatory agencies, and contractors. * Prepare monthly QAQC Reports to identify areas of concern, compliance, recommendations to improve performance. * Continuous Improvement: * Analyze quality trends and data to identify opportunities for process improvement. * Recommend and implement best practices to enhance overall construction quality. Essential Experience: * Education: * Bachelor's degree in Civil, Mechanical, or Structural Engineering, Construction Management, or related field preferred. Equivalent experience may be considered. * Experience: * Minimum 5-7 years of experience in construction quality control, preferably in commercial, industrial, or federal/military projects or requisite field experience. * Prior experience with government contracts (e.g., USACE/NAVFAC) is a plus. * Certifications (Preferred): * USACE Construction Quality Management (CQM) Certification * OSHA 30-Hour Certification * ACI, ICC, or other relevant technical certifications * Skills & Abilities: * Strong knowledge of construction methods, materials, standards, and regulations. * Excellent attention to detail, organizational, and analytical skills. * Proficient in reading and interpreting blueprints and specifications. * Strong written and verbal communication skills. * Proficiency with MS Office and construction management software (Procore, Primavera, Bluebeam). If you are interested in being part of an innovative and collaborative team, in a challenging and rewarding work environment, we want to hear from you! We are always trying to stay a step ahead of emerging trends in the industry. Every employee is part of the process and part of our success. DEW's philosophy is to invest in people and inspire them to bring the best of themselves to work every day. In addition to offering competitive wages and a comprehensive benefits package, employees are given opportunities to learn, develop and grow. These are the reasons DEW is named amongst the top places to work in New Hampshire and Vermont. We are an Equal Opportunity Employer.
$74k-105k yearly est. 60d+ ago
Senior Manager QA Commercial & Life Cycle - CI, BI & DS (Maternity Cover)
Genmab
Quality assurance manager job in Grafton, MA
At Genmab, we are dedicated to building extra[not]ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! The role As part of Genmab's strategy to strengthen end-to-end quality oversight across the supply chain, we are seeking a Senior Manager QA - CI, BI & DS to ensure continued strong GMP quality oversight during a period of parental leave with an expected duration until ultimo January 2027. The role is based in Denmark and reports to the Director responsible for QA Commercial. You will be part of an experienced and highly skilled QA team responsible for quality oversight of Chemical Intermediates (CI), Biologic Intermediates (BI), and Drug Substance (DS), working closely with CMOs, partners, and internal SMEs. Key Responsibilities Provide GMP QA oversight of CI, BI, and DS manufacturing activities at external CMOs Review and approve deviations, CAPAs, change controls, and investigations in accordance with Genmab SOPs and regulatory requirements Support batch disposition activities and ensure appropriate quality decisions for CI, BI, and DS including QA review Contribute to Product Quality Reviews (PQR/APR) for CI, BI, and DS Review, author, and maintain QMS documentation, including SOPs, work instructions, and templates Act as QA representative in cross-functional project teams and advise on GMP compliance and regulatory expectations Maintain strong collaboration with internal stakeholders, partners, and CMOs to ensure robust and compliant supply chains Requirements Bachelor's or Master's degree in a relevant life science discipline Minimum 5 years' experience in the pharmaceutical industry, preferably within QA GMP Experience with CI, BI and DS GMP production and delegated QP responsibilities Excellent communication and collaboration skills; fluent in English Ability to thrive in a fast-paced and changing environment Results-oriented and committed to contributing to Genmab's overall success About You You are genuinely passionate about our purpose You bring precision and excellence to all that you do You believe in our rooted-in-science approach to problem-solving You are a generous collaborator who can work in teams with a broad spectrum of backgrounds You take pride in enabling the best work of others on the team You can grapple with the unknown and be innovative You have experience working in a fast-growing, dynamic company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so! Locations Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO ) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).
$110k-155k yearly est. 1d ago
Food Safety Quality Assurance Coordinator
LSG Sky Chefs 4.0
Quality assurance manager job in Boston, MA
Job Title: Food Safety Quality Assurance Coordinator Salary Range: $18.00 - 25.00 per hour About us LSG Sky Chefs is one of the world's largest airline catering and hospitality providers, known for its outstanding reputation and dynamic approach in the industry. Voted "Airline Caterer of the Year in North America" for 2023 and 2024, we are committed to excellence and innovation, driven by the dedication and expertise of our talented employees. Our team members are the heart and soul of our success, consistently delivering exceptional culinary experiences and outstanding service to our clients and their passengers across North and Latin America. Role Purpose Statement Primary responsibility is to maintain the "Global Quality System" of LSG Sky Chefs to ensure the Customer Service Center (CSC) is in compliance with customer, Federal Drug Administration (FDA), US Department of Agriculture (USDA), and Seafood Hazard Analysis and Critical Control Points (HACCP) plans including USDA and FDA regulatory standards. Main Accountabilities Maintain and initiate all recordkeeping and key performance indicators pertinent to the Quality Department and GQS to include, but not limited to Food Safety, Sanitation, Regulatory Agencies (County Health, State Health Dept. and FDA), internal customers and airline customers Daily monitor of Good Manufacturing Practices (GMPs) for compliance Verify of coolers and freezer room temperature for compliance Perform environmental swabs and microbiological sampling, submittal to local laboratory for analysis Obtain Chef Table samples to verify compliance to specification Assist the Quality Manager in specific training and daily initiatives addressing quality, food safety, and sanitation issues to drive process improvements Conduct work station inspections to verify compliance (gold standard verification, specs, sanitizer, food temperatures, HACCP documentation, phf set-up) Conduct portion control weight compliance to specifications Conduct inspection checks (dispatch, galley, non-bonded, bonded, equipment) Verify Hazard Analysis and Critical Control Points (HACCP) logs and other documents are accurately completed on a daily basis Create charts, trending reports, training materials and visuals Maintain, monitor standards and train employees in compliance to the Regulated Garbage Standards to meet USDA requirements Supports the Jump-off (commissary) locations with oversight Train hourly employees as needed Perform other tasks as requested Knowledge, Skills and Experience High School Diploma or equivalent Proficient in using computer and basic software such as Microsoft, create and maintain trending charts, SOP's, use of calculator, weight scales, and thermometers, metal detector, ATP testing equipment, mechanical food portioning and processing equipment. Previous food industry and quality assurance experience a plus Ability to work in cold environment ( Ability to work with minimum to no supervision, act in liaison of the Supervisor, self-starter, and problem solver. Ability to lift/push a minimum of 25 lbs. Strong mathematical, analytical, verbal, written, interpersonal and organizational skills Ability to work in fast paced environment with large groups Must be flexible to work weekends/holidays LSG Sky Chefs is an EEO and Affirmative Action Employer of Women/Minorities/Veterans/Individuals with Disabilities.
$18-25 hourly 17h ago
Quality Engineer, Analytical Development and Quality Control
Vaxess Technologies
Quality assurance manager job in Woburn, MA
Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess' patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world. The Role The Research Associate/Quality Engineer will be responsible for performing mechanical testing of materials and components using instruments such as Mecmesin, Instron, or equivalent force-measurement systems. This role will support tensile, compression, shear, puncture, and force displacement characterization to ensure product performance, robustness, and compliance with internal quality standards. In addition, the individual will contribute to method development, qualification activities, and routine QC release testing to support clinical and commercial manufacturing programs. This is a unique opportunity to be part of an emerging early-phase clinical company bringing innovative technology to the global market. Key Responsibilities Essential duties and responsibilities include the following. Other duties may be assigned. Perform mechanical testing of materials, components, and finished MAP products using Mecmesin, Instron, or comparable systems, including tensile, compression, shear, puncture, and force displacement profiling. Develop, optimize, and maintain mechanical test methods to support product characterization, comparability studies, and design verification/validation activities. Execute routine QC mechanical release testing aligned with cGMP expectations and data integrity standards. Troubleshoot mechanical testing issues, support instrumentation maintenance, and ensure proper calibration and documentation Analyze mechanical test data, prepare technical reports, and document all activities in audit-ready laboratory records. Collaborate cross-functionally with QC, Analytical Development, Process Development, Manufacturing, and Regulatory teams to enable program success. Assist in broader QC testing efforts as needed, including support for analytical, functional, and stability assays. Independently author method SOPs, analytical protocols, technical reports, and contribute to regulatory submissions. Maintain rigorous laboratory documentation and complete, audit-ready analytical records. Collaborate effectively with QC, Manufacturing, Process Development, and Regulatory teams to enable program success across phases. Thrive in a fast-paced, cross-functional environment with excellent communication and organizational skills. Qualifications Bachelor's degree in Mechanical Engineering, Materials Science, Biomedical Engineering, or a related discipline; 1-3 years of relevant mechanical testing or QC experience, or a master's degree with applicable laboratory experience. Hands-on experience with mechanical testing instruments such as Mecmesin, Instron, Texture Analyzer, or equivalent force-measurement systems. Demonstrated proficiency in tensile, compression, shear, puncture, and force-displacement mechanical characterization. Experience developing, optimizing, and/or qualifying mechanical test methods for materials, components, or finished products. Familiarity with GMP, GLP, or ISO 17025 laboratory environments and strong understanding of data integrity (ALCOA+). Ability to analyze mechanical test data, generate clear technical reports, and maintain accurate documentation. Experience supporting QC release testing, method qualification, method transfer, or equipment qualification is a plus. Strong organizational skills with the ability to manage multiple workflows and prioritize effectively in a fast-paced environment. Excellent verbal and written communication skills and comfort working within interdisciplinary teams. Commitment to collaborative work within interdisciplinary project teams. At Vaxess, we're bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to ****************** .
$69k-95k yearly est. 19h ago
Principal Engineer, AI-Driven QC & Data Consumption
Vertex Pharmaceuticals (San Diego) LLC 4.6
Quality assurance manager job in Boston, MA
A leading global biotechnology firm in Boston seeks a Principal Engineer to lead the automation of pre-clinical data pipelines and regulatory reporting solutions. This role focuses on driving modernization and standardization initiatives, leveraging AI technologies, and enhancing data consumption practices. Candidates should possess strong programming skills and a degree in a relevant field, with a minimum of five years in technical leadership within the biotechnology industry. The position offers a hybrid work model and a comprehensive benefits package. #J-18808-Ljbffr
$105k-132k yearly est. 19h ago

Learn more about quality assurance manager jobs

How much does a quality assurance manager earn in Medford, MA?

The average quality assurance manager in Medford, MA earns between $69,000 and $145,000 annually. This compares to the national average quality assurance manager range of $70,000 to $140,000.

Average quality assurance manager salary in Medford, MA

$100,000

$69,00010%

$100,000Median

$145,00090%

What are the biggest employers of Quality Assurance Managers in Medford, MA?

The biggest employers of Quality Assurance Managers in Medford, MA are:

Maximus
Entrada Therapeutics
Danaher
3 Key Consulting
Wave Life Sciences
Do+Able Products Inc
LSG Sky Chefs
Hilton
AIG
Railroad Construction

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Quality Assurance Manager Medford, MA Jobs

Quality assurance manager jobs in Medford, MA - 803 jobs

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Learn more about quality assurance manager jobs

How much does a quality assurance manager earn in Medford, MA?

What are the biggest employers of Quality Assurance Managers in Medford, MA?