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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. 22h 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
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 19h ago
Quality Assurance Specialist 21CFR GMP
Top Prospect Group
Quality assurance manager job in Fall River, MA
Please note our client does not Sponsor Job Role: IT-QA Work Hours: General: 8:00AM - 5:00PM (May vary based on business needs) Reports To: Site Quality Assurance Head Salary Range: $67,000 - $95,000 - PURPOSE The purpose of the IT - QA Associate position is to accurately review the chronological record of Laboratory Instrument/Equipment electronic data related activities that provides documented evidence of relevant details of specific events. JOB DESCRIPTION The IT- QA Associate position is an individual contributor role and a member of the Pharmaceuticals Quality Team. The position monitors changes to electronic records, alterations in critical parameters or any other actions that could impact product quality. This position reports to the Site Quality Head. The job duties for this position include but are not limited to the following: Function as SME for IT related activities of QMS platforms and other electronic systems including digital platforms which need compliance to 21CFR, Part 11 requirements. Conduct regular audits of the audit trail to identify any irregularities or potential issues. Additionally, routinely review and analyze the data to proactively address any emerging trends or areas for improvement. Provide comprehensive training to employees involved in the analytical laboratory related activities as well as manufacturing process who are entitled to use digital platforms for execution of GMP/GLP activities. Ensure that users understand the importance of audit trail integrity and data integrity and their role in maintaining accurate and reliable records and adhering to cGMP compliance. Provide support for investigation and implementation of CAPA related to such investigation. EDUCATION AND EXPERIENCE QUALIFICATIONS B.Sc. in a scientific discipline related to the pharmaceutical industry (Biology, Chemistry, Pharmacology, Biochemistry, etc). Basic knowledge and Industry experience of Quality System relevant to electronic records storage, retrieval, archival and audit of electronic data is must. Minimum of two (2) years' experience in a quality assurance in a GMP environment specific Quality Control Laboratory and Manufacturing operations in a pharmaceutical manufacturing organization. Experience in MDI or DPI dosage form manufacturing preferred. KNOWLEDGE, SKILLS, AND ABILITIES Candidates must have an aptitude for quantitative problem-solving or advanced analytics. Ability to multitask efficiently, prioritize quickly, and manage time effectively. Candidates must have experience in writing and executing performance tests. Database and computer skills; talent for analyzing and visualizing complex data. Advanced proficiency with Microsoft Excel. Must have current Good Manufacturing Practices (cGMP) knowledge. Must have strong attention-to-detail. Must be a self-starter and demonstrate initiative with seeking additional training or direction as needed. Must have strong organization and communication skills (written, verbal, and presentation). Must be detail-oriented with the ability to prioritize tasks with strict deadlines.
$67k-95k yearly 1d 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 22h 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. 22h 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, External Quality Assurance
Sana Biotechnology Inc. 4.4
Quality assurance manager job in Cambridge, MA
About the role Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who are passionate about delivering the possible to patients, and who lead with the desire to work on novel ideas. As a Director of External Quality Assurance, you will report to Head of Technical Quality to provide Quality oversight on manufacturing operations at Contract and Development Manufacturing Organizations (CDMOs). The scope of work will include Sana's programs from pre-clinical, clinical and subsequently commercial operations serving the US and ex-US regions. The role will include performing Quality person in the plant (PIP) activities at CDMOs for critical operations. This role will also require supporting external audits of Sana's suppliers and contract services. Approximately 30% travel may be required. What you'll do * Provide leadership and quality oversight for operations at Sana CDMOs, which may require onsite support at the CDMO. * Represent Quality at internal and external project team meetings and build relationships with Quality counterparts at CDMOs and CTLs. * Perform batch review and ensure timely and accurate batch disposition of materials and/or Sana products. * Partner with technical departments to help ensure success of technical transfer activities from Sana to the CDMO partners. * Partner with CDMO to identify and address gaps or areas for improvement in systems, procedures, and quality initiatives. * Collaborate with other functions in CDMO Manufacturing, QC, and Process Development teams to evaluate, investigate and resolve issues. * Responsible for batch release of Sana products manufactured at CDMOs. * Understand the Quality Management System and influence phase-appropriate SOPs, change control, investigations, CAPA, compliance, document management, training management and validation. * Establish and maintain Quality Technical Agreements and ensure alignment with other legal contracts as needed with CDMOs and CTLs. * Maintain a Quality Risk Management system to identify and mitigate compliance risks. * Ensure that CDMO facilities, utilities, and equipment are maintained in a validated or qualified state. * Support qualification activities for suppliers, contract testing laboratories, contract manufacturing organizations and contract services. * Perform supplier audits in accordance with Sana requirements. * Support the complaint program; review and approve the complaint reports to ensure all quality complaints are thoroughly investigated and ensure the CAPA plans for the resolution of the complaints are developed and executed. * Serve as the Sana business process owner for Quality batch disposition activities. * Support inspection and/or audit readiness activities for inspections by Health Authorities, and partners. What we're looking for * Self motivated leader who can influence others and exercise sound judgement when managing issues during critical operations. * Experience in working with CDMOs in various product lifecycle stages. * Operational experience in manufacturing aseptic environments, in quality or manufacturing. * Experience in leading and managing complex investigations. * Experience in batch disposition activities. * Familiar with the US, EMA, and ICH regulations and guidance documents * Effective communicator where you can articulate concerns and/or issues in a clear and concise manner. * Demonstrated ability to engage team members across diverse teams. * Ability to effectively prioritize and deliver high-quality results on tight timelines. * Demonstrated ability to independently problem solve including the ability to devise and implement practical solutions to resolve QA issues while being mindful of impact to timelines, resources and conflicting priorities. * Experience in inspection readiness activities, presenting during inspections and/or hosting Health Authority inspections. * Bachelors or Masters plus 10-12 years of work experience. What will separate you from the crowd * Cell and Gene Therapy product experience preferred * Experience in expedited release processes What you should know * Approximately 30% travel may be required. * The role will be based at the Sana Cambridge, MA location and will require onsite presence. * The base pay range for this position at commencement of employment is expected to be between $200,000 - $250,000 annually; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience How we work together for patients * Lead from every seat - we seek to understand, act with honesty, and engage in the crucial conversations * Thrive as a team - we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity * Make it happen - we value vigorous debate, alignment around our decisions, and resilient execution Get to know us At Sana, we believe that a workforce with varied backgrounds strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients. Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover a generous portion of the cost for employee health coverage, making high-quality care more accessible and affordable. We offer ample time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually. For more details on our benefits, visit Sana's Benefits Portal. We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law. To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.
$200k-250k yearly Auto-Apply 48d ago
Director, Clinical Quality Assurance
Biontech Se
Quality assurance manager job in Cambridge, MA
Cambridge, US; Gaithersburg, US; New Jersey, US | full time | Job ID: 9897 As Director, Clinical Quality Assurance Compliance you will lead quality assurance activities across clinical development programs in global teams. This role focuses on implementing a proactive, risk-based quality strategy, ensuring GCP compliance, fostering a culture of quality within the Global Development Organization whilst supporting delivery of our clinical trial portfolio. Responsibilities * Develop and implement a proactive, risk-based Clinical Quality Strategy for assigned high-priority trials or programs, ensuring inspection readiness and GCP compliance * Collaborate with internal teams, collaboration partners as well as external vendors (e.g. CROs) to identify, investigate, and remediate clinical trial risks and quality issues, including CAPAs and effectiveness checks * Actively contribute to Clinical Trial teams by providing quality guidance and reviewing key study documentation * Enable continuous inspection readiness and compliance with GCP, regulatory requirements, and internal standards * Lead or support inspection preparation, facilitation, and follow-up activities * Review and manage Quality Agreements with CROs and other vendors, ensuring compliance with agreed standards * Lead and develop a team, fostering transparency and proactive communication * Drive a culture of quality and continuous improvement across the Global Development Organization, including authoring and reviewing clinical quality procedures. * Acting as an ambassador for quality: ensuring that quality is an enabler of delivery. Qualifications Education * University degree in life sciences; advanced degree preferred Experience * Profound professional experience (beyond 10 years) in a GCP-regulated environment * Strong GCP expertise gained in a senior Quality Management and / or Clinical Operations role. * Strategic and Risk-based mindset with experience developing quality strategies at program level * Solid understanding of global clinical regulations and guidelines (ICH, FDA, EMA, MHRA) * Experience in team leadership and development (in the GCP environment preferred) * Experience in managing, hosting or supporting regulatory authority inspections (EMA/FDA/MHRA) * Proficiency in MS Office and electronic quality management systems * Fluent in English (Mandarin is a plus) Expected Pay Range: $202000/year to $247000/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). *Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities. Your Benefits: BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to: * Medical, Dental and Vision Insurance * Life, AD&D, Critical Illness Insurance * Pre-tax HSA & FSA, DCRA Spending Accounts * Employee Assistance & Concierge Program (EAP) available 24/7 * Parental and Childbirth Leave & Family Planning Assistance * Sitterstream: Virtual Tutoring & Childcare Membership * Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown. * 401(K) Plan with Company Match * Tuition Reimbursement & Student Loan Assistance Programs * Wellbeing Incentive Platforms & Incentives * Professional Development Programs * Commuting Allowance and subsidized parking * Discounted Home, Auto & Pet Insurance …and more! More details to be shared. Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world. As part of the Greater Boston area, the city is often referred to as the "biotech supercluster" due to its high concentration of life sciences firms. This unique ecosystem is the result of a model partnership between academia and industry, fostering collaboration and innovation and driving the development of new therapies, medical devices, and diagnostics. As Cambridge's thriving life sciences industry continues to evolve, the city remains a beacon of knowledge, innovation, and collaboration, poised to shape the future of science and technology. Apply now - We look forward to your application! Apply for our Cambridge, US; Gaithersburg, US; New Jersey, US location and simply send us your documents using our online form. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider 'HireRight'. You will be informed accordingly by your BioNTech-Recruiter. Inspired? Become part of #TeamBioNTech. BioNTech, the story At BioNTech, we are more than just a biotechnology company - we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases. Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine. Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world. BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you! BioNTech - As unique as you ****************
$202k-247k yearly 60d+ ago
Director, Clinical Quality Assurance
Dyne Therapeutics, Inc.
Quality assurance manager job in Waltham, MA
Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more ************************* and follow us on X, LinkedIn and Facebook. Role Summary: The Director, Clinical Quality Assurance leads GCP compliance and quality oversight for clinical programs and commercial products. This role is responsible for developing and implementing risk-based strategies; managing audits, inspections, and vendor oversight; and ensuring global regulatory compliance. This role partners cross-functionally to drive continuous improvement, inspection readiness, and sponsor oversight, while proactively identifying and mitigating quality risks. As a subject matter expert, this role establishes program support to uphold industry best practices and regulatory requirements. This role is based in Waltham, MA. Primary Responsibilities Include: * Inform and contribute to audit planning and strategy * Perform and/or coordinate clinical site and vendor audits * Oversee deviations, quality issues (QIs), CAPAs, effectiveness checks, root cause analyses, and associated KPIs * Advise internal stakeholders and external partners on GCP compliance matters and identify emerging non-compliance trends * Support inspection readiness activities and co-host regulatory inspections * Develop and deliver GCP-related training; contribute to the creation, revision, and maintenance of policies, SOPs, and work instructions in alignment with global regulatory requirements * Conduct and/or manage the qualification and oversight of service providers * Ensure service providers adhere to quality programs and applicable regulations, maintaining inspection readiness * Assess and escalate compliance risks identified through audits to protect subject safety, data integrity, and business continuity * Lead or support the preparation for and response to regulatory audits and inspections, ensuring adherence to requirements and timely resolution of findings * Support investigational new drug (IND) applications and related correspondence with global regulatory authorities Education and Skills Requirements: * Bachelor's degree in a scientific, allied health, or medical field required; Master's degree preferred * Minimum of 10 years of progressive experience in the pharmaceutical or biotechnology industry, including at least 5 years in a Clinical Quality Assurance role (or an equivalent combination of PV and QA experience) * Deep knowledge of global regulations (e.g., FDA, EMA) and guidelines (e.g., ICH, GVP, GxP), including safety reporting requirements * Broad clinical development experience across all phases (Phase I through BLA/NDA) * Strong understanding of GCP quality principles spanning preclinical, clinical, and commercial stages * Proven experience developing and implementing risk-based clinical quality assurance programs * Demonstrated success leading clinical site and supplier audits, managing regulatory inspections, and responding to findings * Skilled at effectively communicating quality events and outcomes to internal stakeholders * Excellent interpersonal, verbal, and written communication skills * Working knowledge of multiple therapeutic areas is a plus * Results-oriented, with the ability to set clear objectives, manage competing priorities, and meet dynamic timelines * Flexible and creative problem solver with a proactive mindset * Highly collaborative team player who fosters open communication and cross-functional cooperation * Willingness to travel up to 20% based on business needs #LI-Onsite MA Pay Range $190,000-$232,800 USD The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
$190k-232.8k yearly 60d+ 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
Commercial Quality Assurance Director*
Aicuris Anti-Infective Cures AG
Quality assurance manager job in Waltham, MA
Your mission The Commercial Quality Assurance Director will be based in Massachusetts and serve as the primary QA contact for commercial operations in the United States, maintaining close alignment with key partners in the United States and Europe. The position requires strategic leadership in developing and expanding a global Quality Management System, as well as extensive knowledge of GMP compliance and regulatory requirements. The Commercial Quality Assurance Director will also manage relationships with external partners, including CMOs, 3PLs, and distributors. The Commercial Quality Assurance Director will also oversee the quality of GMP development partners to ensure seamless integration across the product lifecycle. As we prepare for the launch of pritelivir in 2026, the Commercial Quality Assurance Director will play a critical role in supporting FDA inspection readiness and EMA submission activities while driving quality excellence across global operations. Lead the creation, review, and revision of SOPs to ensure commercial readiness and regulatory GMP compliance. Shape the evolution of the QMS to meet global commercial and regulatory GMP expectations. Implement recall procedures and perform mock recall to ensure recall procedures are adequate. Review, negotiate, maintain and manage quality agreements with CMOs, 3PLs, wholesalers and distributors. Serve as the primary QA contact for external commercial partners (e.g., CMOs, 3PLs, wholesalers, distributors). Develop and deliver training programs on commercial and GMP QA processes across all levels of the organization. Provide strategic oversight of GMP compliance across all outsourced manufacturing and packaging activities. Act as the QA liaison with internal stakeholders (e.g., Supply Chain, CMC, and Regulatory Affairs) and external service providers. Drive vendor qualification, audit strategy, and ongoing performance management. Lead / support internal and external audits, as required. Ensure inspection readiness for the FDA and support EMA submission activities within your area of responsibility. Prepare, review, and/or approve high-impact quality documentation, including batch records, deviations, CAPAs, change controls, product complaints and product quality reviews. Support product release processes and ensure timely QA support for supply chain operations. Drive continuous improvement initiatives within the commercial/GMP QA framework. Your profile Bachelor's, master's, or doctoral degree in a relevant scientific discipline (e.g., biology, chemistry, or pharmacy). Minimum 7 years of experience in biotech/pharma with exposure to commercial products. Deep understanding of FDA regulations (21 CFR Parts 210/211 and 600) and EU GMP (EudraLex, Volume 4) and global commercial quality standards. Proven experience in building and scaling QMS for commercial operations. Ideally, experience with computerized system validation in a GxP-regulated environment. Strong strategic thinking, communication, and stakeholder management skills. Detail-oriented with strong analytical and problem-solving abilities. Experience working in global regulatory environments and managing international QA operations is a plus. Ability to travel occasionally for audits, inspections, and team meetings. Close collaboration and alignment with the global QA team in Germany. Fluency in English. Why us? Unique corporate culture: Scientific excellence, a collaborative working environment and the passion to improve the lives of patients defines our work. With us, you can work together with innovation awarded experts with the proven ability to translate science into commercial success. You can expect diversity, inspiration, as well as trustful collaboration. Development: We encourage people to grow and strongly support individual development and learning opportunities. Flexibility: Embracing flexible working accommodations, we enable our people to integrate business into their personal life. Benefits: Competitive comprehensive benefit plan. About us AiCuris is meeting the needs of the growing population of immunocompromised people who require precise therapies to effectively treat infection. Our flagship product, PREVYMIS, marketed by our partner MSD, treats CMV in a defined group of transplant recipients. Our pivotal phase 3 candidate Pritelivir aims to address recurrent and resistant HSV infections in a broad population of patients with weakened immune systems. For immunocompromised people, an otherwise manageable infection can mean life or death. AiCuris, with its expertise and growing pipeline, is committed to providing therapeutic solutions for them now and in the future. We believe in a culture of trust and transparency, where feedback is considered an opportunity to contribute to each other's personal and professional growth. We hire people who are collaborative, adaptable, communicate well, and love to learn. *AiCuris is an employer that supports equal opportunities, diversity and inclusion. We welcome applications from people regardless of their national origin, skin color, religion, gender, age, marital status, disability, sexual orientation, gender identity or other legally protected characteristics.
$112k-161k yearly est. 45d ago
Director of QA
Intralinks 4.7
Quality assurance manager job in Boston, MA
As a leading financial services and healthcare technology company based on revenue, SS&C is headquartered in Windsor, Connecticut, and has 27,000+ employees in 35 countries. Some 20,000 financial services and healthcare organizations, from the world's largest companies to small and mid-market firms, rely on SS&C for expertise, scale, and technology. Job Description Job Title: Director of QA Locations: Boston, MA or Windsor, CT | Hybrid Get To Know Us: We are a fast-paced, dynamic team, who are leaders in technology and responsible for developing, maintaining, implementing, and expanding our next-generation platform for insurance companies. Singularity is a cloud-based, AI-powered platform for insurers and investment managers that provides integrated accounting, operational processing, and advanced analytics for all asset types. Why You Will Love It Here! Flexibility: Hybrid Work Model and Business Casual Dress Code, including jeans Your Future: 401 (k) Matching Program, Professional Development Reimbursement Work/Life Balance: Flexible Personal/Vacation Time Off, Sick Leave, Paid Holidays Your Wellbeing: Medical, Dental, Vision, Employee Assistance Program, Parental Leave Wide Ranging Perspectives: Committed to Celebrating the Variety of Backgrounds, Talents, and Experiences of Our Employees Training: Hands-On, Team-Customized, including SS&C University Extra Perks: Discounts on fitness clubs, travel, and more! What You Will Get To Do: The Director of QA is responsible for defining and executing a consistent and repeatable process for full product testing, deployment, and release for Insurance software solutions. The Director must have strong leadership and planning skills and be able to manage both large and small projects through an iterative lifecycle model. Ensures that products meet end-user functional and design requirements as well as performance and scale expectations through the execution of software quality tests. Defines and executes integration, performance, regression, and/or acceptance testing. Develops and supports the test automation environment for executing software quality tests. Leader with broad operational or functional responsibilities who participates with other senior leaders or executives to establish and ensure the achievement of strategic plans and objectives. Demonstrates in-depth company knowledge, specialized skills, and influence to solve critical and complex issues. Participates in the development and administration of broad-scope programs and projects that have a significant impact on operational or functional success. The Director will manage a team across multiple locations and will be responsible for defining and executing the test strategy, maintaining a build environment throughout the iterative development cycle, and building the final release of the product to deliver to market. The incumbent for this role will: • Define and maintain project plans to manage delivery schedule, resource management, task tracking, and status reporting through testing and release phases of projects • Define and execute a consistent, repeatable process for QA • Maintain an efficient, high-quality library of scripts for automated testing • Deliver a clear release-to-market certificate for all product releases • Maintain reliable infrastructure to support source control, build, and release environment • Deliver a reliable and repeatable deployment model for all products • Manage day-to-day task assignment and team member workload • Manage progress and status for a cross-functional team across multiple projects • Establish SMART goals and career development for team members and review/reset as necessary What You Will Bring: Candidates must have led product QA organizations with oversight over the parts of the software development process that involve QA testing and release readiness, and have experience with SaaS software applications in the financial services sector. 10-15 years of experience in the financial industry 10 years in a QA leadership position A candidate should have extensive experience implementing the testing and QA approach as applied to a business or a product Candidate must have planning and presentation skills The Candidate must have strong leadership abilities and the ability to provide direction Education: B.A. or B.S. required Thank you for your interest in SS&C! If applicable, to further explore this opportunity, please apply directly with us through our Careers page on our corporate website @ ************************ Salary range for the Position is expected between $150,000.00 and $175,000.00. The successful candidate may be eligible for an annual discretionary incentive compensation award. #LI-DS3 #LI-HYBRID Unless explicitly requested or approached by SS&C Technologies, Inc. or any of its affiliated companies, the company will not accept unsolicited resumes from headhunters, recruitment agencies, or fee-based recruitment services. SS&C offers excellent benefits including health, dental, 401k plan, tuition and professional development reimbursement plan. SS&C Technologies is an Equal Employment Opportunity employer and does not discriminate against any applicant for employment or employee on the basis of race, color, religious creed, gender, age, marital status, sexual orientation, national origin, disability, veteran status or any other classification protected by applicable discrimination laws.
$150k-175k yearly Auto-Apply 17d ago
Quality Supplier Manager
Edesia Nutrition 4.5
Quality assurance manager job in North Kingstown, RI
ABOUT THE ORGANIZATION: Edesia is a non-profit social enterprise on a mission to end global malnutrition. We manufacture and distribute life-saving, ready-to-use therapeutic foods-such as Plumpy'Nut and Nutributter-to treat and prevent malnutrition among children and mothers in the world's most vulnerable and hard-to-reach communities. Through strong partnerships with leading humanitarian organizations, NGOs, and Ministries of Health, we ensure our products reach those who need them most-even in the midst of the most complex and challenging humanitarian emergencies. JOB SUMMARY: The Quality Supplier Manager is responsible for ensuring that all domestic and international suppliers meet Edesia's high standards for food safety, quality, and compliance. This role will oversee supplier approval, verification, and monitoring programs to ensure consistency with regulatory requirements, industry standards, and Edesia's internal quality management systems. The individual will be instrumental in driving continuous improvement, strengthening supplier partnerships, and ensuring the integrity of Edesia's supply chain. In addition, this role will serve as the primary point of contact during customer and certification audits, supporting preparation, documentation, and responses to demonstrate compliance and supplier program effectiveness. RESPONSIBILITIES AND DUTIES: Supplier Management & Approval Lead the supplier approval process for both domestic and foreign suppliers, including documentation review, risk assessment, and compliance checks. Manage and maintain Edesia's Approved Supplier List (ASL), ensuring timely updates and compliance with regulatory and customer requirements. Develop, distribute, and evaluate supplier questionnaires, scorecards, and risk-based assessments. Work closely with the Quality Director and Senior Director to address supplier-related issues, out-of-specification batches, and recurring or emerging quality trends. Collaborate on root cause analyses, escalation of critical supplier problems, and development of strategic actions to improve supplier reliability and performance. Supplier Audits & Verification Manage the Supplier Assurance Program for (domestic and foreign) ensuring compliance with Edesia's standards, GFSI schemes, and applicable regulations. Verify and validate the audit schedule based on risk, organizing supplier visits, and ensuring that audit reports are reviewed and filed appropriately. Additionally, ensure that corrective and preventive actions are obtained from suppliers following the visits. Manage the Foreign Supplier Verification Program (FSVP) in compliance with FDA and FSMA requirements. Partner with cross-functional teams to evaluate supplier performance and implement corrective/preventive actions (CAPAs) when needed. Documentation & Compliance Review and maintain supplier documentation, including food safety certifications, specifications, questionaries, etc. Ensure all foreign suppliers maintain compliance with U.S. import regulations and certifications. Maintain audit records, risk assessments, and supplier documentation in alignment with regulatory and certification requirements (e.g., BRCGS, FDA, and customer requirements). Performance Monitoring & KPIs Develop and maintain supplier performance scorecards, monitoring key performance indicators such as quality, service, compliance, and cost. Identify trends in supplier performance data and work with suppliers to implement improvements. Provide regular reports on leadership on supplier performance and risk. Leadership and Continuous Improvement Directly oversee the Quality Assurance Technician fostering their development and ensuring alignment with quality standards. Review and approve the QA technician's material sampling for product release, ensuring compliance with quality standards and specifications. Collaborate with Procurement, Quality, and R&D teams to evaluate new and existing suppliers for innovation, efficiency, and risk mitigation. Recommend and implement improvements to Edesia's supplier management systems and processes. Support production and quality teams in troubleshooting raw material quality issues and minimizing supply disruptions. QUALIFICATIONS: B.S. in Nutrition or Food Science-related field. Minimum 5 years of experience in supplier quality management, quality assurance, or procurement within food manufacturing or a regulated industry. Must have knowledge and experience with food safety regulations such as HACCP, GFSI Standards, Codex, GMP's, SSOP programs and US food regulations. Must have experience interacting with regulatory agencies and customer inspections. Able to work effectively and efficiently in cross functional team environments. Strong communication skills and ability to interact with all levels throughout the organization. Highly innovative and creative. Excellent organization/time management and problem-solving skills. Strong customer focus and ability to prioritize and adapt to compliance and business needs required. Strong computer skills (proficient with Power Point, Excel and Word) and familiar with SAP. WORK CONDITIONS: General office environment, plus time spent in Quality lab and production area. Occasional lifting, bending, pulling, some of which could be heavy (>15 lbs) or require the use of carts. High utilization of office equipment, phone, computer, etc. Ability to travel up to 50% of the time, both domestically and internationally, to conduct supplier visits, audits, and inspections. Must be able to travel to vendors/partners as well as domestic and international conferences and meetings related to quality. HOURS: 8:00 am to 4:30 pm (may be required to work other shifts/hours, as needed to support projects) The requirements described are representative of those that must be met to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
$89k-110k yearly est. 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
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 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. 22h ago

Learn more about quality assurance manager jobs

How much does a quality assurance manager earn in Cranston, RI?

The average quality assurance manager in Cranston, RI earns between $65,000 and $136,000 annually. This compares to the national average quality assurance manager range of $70,000 to $140,000.

Average quality assurance manager salary in Cranston, RI

$94,000

$65,00010%

$94,000Median

$136,00090%

What are the biggest employers of Quality Assurance Managers in Cranston, RI?

The biggest employers of Quality Assurance Managers in Cranston, RI are:

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Quality Assurance Manager Cranston, RI Jobs

Quality assurance manager jobs in Cranston, RI - 459 jobs

Testing Lead (Hiring Immediately)

US/LATAM Spanish LQL Linguistic Quality Lead

Director, R&D Quality Governance & Risk

Quality Systems & Investigations Specialist

Quality Assurance Manager - Food Safety

Quality Assurance Specialist 21CFR GMP

Quality Systems Specialist

Director, GMP QA

Principal Engineer, AI-Driven Data QC & Reporting

Director, Regulatory Affairs and Quality Assurance

Director, External Quality Assurance

Director, Clinical Quality Assurance

Director, Clinical Quality Assurance

Director, Clinical Quality Assurance

Commercial Quality Assurance Director*

Director of QA

Quality Supplier Manager

Clinical Quality Program Manager

Food Safety Quality Assurance Coordinator

Principal Engineer, AI-Driven QC & Data Consumption

Learn more about quality assurance manager jobs

How much does a quality assurance manager earn in Cranston, RI?

What are the biggest employers of Quality Assurance Managers in Cranston, RI?