Quality assurance manager jobs in Manchester, NH

A recognized pharmaceutical company is actively seeking a new Quality Assurance (QA) Specialist to ensure data integrity and system compliance across clinical systems and cloud technologies. Responsibilities: Develop, document, and execute test plans, scenarios, and test cases for clinical trial applications and data workflows Perform functional, regression, and integration testing to validate new features and ensure existing functionality remains intact Utilize QTest for test management and documentation Conduct defect management, including logging, tracking, and verifying fixes Collaborate with development teams in an Agile environment to ensure timely and accurate testing Identify and resolve data quality issues at the business level, ensuring compliance with regulatory standards Work closely with stakeholders to validate requirements and deliver high-quality solutions Qualifications: 5+ years of QA experience in the Clinical Trials / Pharma domain Strong knowledge of AWS, Databricks, and clinical systems (CTMS, EDC, eTMF) Proficiency in QTest for test case management Experience with SQL and Athena for data validation Experience with Python (ability to read and understand code) Microsoft Excel (pivot tables, linked spreadsheets) Familiarity with Jira for issue tracking and Agile workflows Strong analytical and problem-solving skills with attention to detail Desired Skills: Solid understanding of Clinical Data standards (CDISC, SDTM) Knowledge of GxP Compliance and Regulatory requirements

Masis Professional Group is recruiting for a Food Safety and Quality Assurance Manager on behalf of our client located in Leominster, MA. This is a direct hire opportunity offering a competitive hourly salary and benefits package. FSQA Manager, or Food Safety and Quality Assurance Manager, is responsible for ensuring that food products meet all safety, quality, and regulatory standards. This involves developing and implementing food safety programs, conducting audits, overseeing compliance with regulations, and training staff on proper safety protocols. Requirements of the Food Safety and Quality Assurance Manager: Experience working with GFSI auditing - SQF preferred SQF Practitioner PCQI - FSMA training HACCP Training Proficient with Microsoft office suite 2-5 years' experience managing a team Familiar with prerequisite programs - allergen, supplier management, sanitation, recall and traceability etc. Able to lead and determine root cause analysis in a corrective and preventive action situation. Able to review and respond to customer complaints. Ability to identify and correct nonconformities in system processes, gmps, and employee practices. Confidently communicate resource needs to upper management. Implement, monitor, and provide training related to food safety plan, gmps and industry best practices. Desirable Requirements of the Food Safety and Quality Assurance Manager: Bilingual with Spanish Food Defense Training Internal Auditing training Experience working with food contact packaging Experience working with regulatory agencies Experience reviewing and formatting NLEA labeling, Ingredient statements, allergen statements and claims to meet CFR regulations.

Department: Quality Assurance Vaxess is a NIH and venture-funded company developing a pipeline of next-generation vaccines and therapeutics on the MIMIX platform. With only five minutes of wear-time on the skin, the self-applied MIMIX patch enables up to two weeks of sustained delivery. The platform combines high 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 Quality System Specialist / Senior Quality System Specialist plays a key role in supporting and enhancing Vaxess Technologies' Quality Management System (QMS) to ensure compliance with applicable GMP/GLP standards. This position focuses on maintaining robust electronic quality systems, managing controlled documentation, and supporting the integration of new processes and applications. Key Responsibilities: Quality System and Computerized System Oversight Support quality oversight for computerized systems, including QMS implementation, configuration, validation, and data migration activities. Assist in launching new or enhanced system functionalities and communicating updates or user guidance to ensure effective adoption. Collaborate with internal stakeholders and system vendors to ensure integrated processes across modules (Document Control, Training, Equipment, and Material Management). Troubleshoot and resolve user issues as needed. Documentation and Record Management Manage the full lifecycle of controlled documents, including creation, revision, review, approval, distribution, and archival within the electronic document management system (EDMS). Ensure that controlled documents, such as SOPs, batch records, and specifications, are accurate, current, and compliant with regulatory and internal requirements. Coordinate document workflows with cross-functional teams to ensure timely completion and alignment with procedural requirements. Author or revise SOPs, forms, and work instructions supporting quality system and GMP operations. Training and Compliance Support Provide training and day-to-day support to employees on document control and system processes. Serve as a subject matter expert (SME) for document control and computerized systems during internal and external audits and inspections. Support tracking and reporting of quality metrics (e.g., training completion, document cycle time, CAPA effectiveness) to drive continual improvement. Qualifications: Bachelor's degree in Life Sciences, Engineering, or a related discipline preferred; equivalent work experience considered. 2-5 years of experience in a GMP, GLP, or GxP-regulated environment (pharmaceutical, biotechnology, or medical device industry). Experience with electronic quality management systems (e.g., Enzyme, Greenlight Guru, Veeva, MasterControl, etc.) is strongly preferred. Familiarity with relevant regulations and standards (21 CFR Parts 210/211/11/820; ISO 9001/13485). Excellent attention to detail, organization, and communication skills; ability to manage multiple priorities in a dynamic environment. Collaborative, proactive, and adaptable work style aligned with a fast-paced, innovation-driven company. Vaxess, a venture-backed life sciences company, is building a team of exceptional people to rapidly advance products on its microneedle array platform. We work closely as a team and thrive in a dynamic, exciting, and engaging work environment. If you're interested in joining the Vaxess team, please submit your CV/resume to ****************** .

Who We Are Strand Research is a biotechnology startup dedicated to developing and optimizing novel molecules for haircare applications to be launched in a new brand. Positioned at the crossroads of science and beauty, we are committed to innovation driven by rigorous data and relentless pursuit of efficacy, creating solutions that will set new industry standards and redefine what is possible in hair care. Our lab is based in Kendall Square and we have secured substantial funding, providing us with several years of runway to bring groundbreaking ingredients to market. We have made major progress on the science side, and are now looking for a R&D strategy manager to help turn that innovation into real, high-impact products. The ideal candidate is a results-driven, high octane, resourceful individual who thrives in a fast-paced, high intensity environment with a passion for science and consumer goods. You will partner directly with scientists and leadership to shape program strategy, define what “good” looks like, and help identify the most promising directions across our portfolio. You'll translate high-level scientific concepts into focused, achievable plans, ensuring that every project has clarity and momentum. We're looking for a sharp generalist with both strategic depth and executional grit, someone who can move fast, wear multiple hats, and help shape our research outcomes. What You Will Do Work with scientific leads to define hypotheses, sharpen project goals, and prioritize the programs with the highest potential impact Build clear, aggressive plans that translate research into focused milestones and decision points Help shape and execute our IP strategy, pulling in the technical narratives and experimental data to strengthen and accelerate our filings Deliver strategic updates that give leadership visibility into progress, roadblocks, and opportunities across the R&D portfolio Build and lead relationships with vendors, CROs, academic partners, and other external partners to accelerate progress to market Do whatever it takes to move our best leads through development and into market-ready products Who You Are 3-5+ years of full-time experience in consulting, finance, high-growth start-up, or similar high-intensity role Scientific degree or deep, self-driven interest in science A self-starter with a desire to win Disciplined and organized, with the ability to create structure for ambiguous problems Strong interpersonal skills with ability to manage many different stakeholders A “doer” and a thinker who is willing to get hands dirty in execution while maintaining a strategic mindset Strong analytical skills with a bias for insights and results Passionate about the intersection of science and the consumer Additional Information This position is hiring for an immediate start, with some flexibility for the right candidate This position is in-office in Cambridge, MA The salary for this position is commensurate with experience Interested? Reach out to learn more and apply at ************************

WHO WE ARE Nextphase.ai is a Data Management solution provider focused on Data Operations services for enterprise data in the cloud. We are leading the innovation agenda with our clients by delivering a portfolio of services to help them improve data quality and manage data governance for their cloud data. NextPhase.ai data management services are tailored to achieve our client's business outcomes thus enabling our clients to focus on monetizing their data while we handle data operations. Nextphase.ai provides you with a dynamic and fun work environment and encourages you to use creative thinking to solve client challenges. Position Overview: We are seeking a dynamic, analytical thinking individual to join our Quality team, this is a contract position focusing on Quality Systems, CAPA, Complaint handling, Internal Audit, metric reporting and process improvement initiatives. The ideal candidate will possess a strong background in medical devices or IVD, with a proven track record in managing quality-related activities in a fast-paced dynamic environment. QMS experience is essential. Responsibilities: This position is responsible for, but not limited to, the following: Supports the overall QMS processes for the organization. Responsible for activities required to ensure compliance of Quality Management Systems (QMS), specifically regarding CAPA, complaints and internal/external audits. Additional responsibilities include supporting other QMS functions such as NCMRs, Supplier Controls, Management Review, Risk Review, etc. Execution and coordination of activities associated with CAPA program, including administration and record management, providing quality input to investigations, reporting, as well as metrics and trending Support CAPA Owners in quality-related technical principles, including but not limited to Problem Solving tools and techniques (Root Cause Analysis, DOE, FMEA, etc.) Investigate customer complaints, from intake through investigation and closure Manages the Internal Audit program, including scheduling audits, ensuring timely response to findings, as well as metrics and trending Development of Quality Metrics, and coordination of quality data collection and analyses for use in monthly metrics meetings and Management Reviews Provide quality assurance support cross-functionally across the organization Develop, implement, and manage Quality Control/Quality System process improvements. Identify opportunities for improvement within the Quality System to ensure compliance and efficiency. Correct or improve gaps/opportunities in an independent fashion by writing and releasing new or revised Quality System documentation Understand how and when to escalate quality issues to leadership team within the organization, presenting data and information necessary to draw conclusions and take action Provide training and support to employees on quality processes and procedures Support work on quality plans, quality processes Minimum Qualifications: Bachelor's Degree in Engineering, Biomedical Science, or other technical discipline preferred, with 3-6 years of relevant experience in medical device industry, including responsibility for Product Quality and/or Quality Systems A working knowledge of Quality System Standards and regulations, including 21 CFR Part 820, ISO 13485, EU MDR Preferred Qualifications: Ability to multitask, handling multiple projects and changing priorities Experience in the creation and documentation of procedures and processes Must be results-driven and exhibit a sense of urgency Proficiency with Microsoft Office - Word, Excel, PowerPoint and Access experience required Ability to communicate ideas and information clearly, effectively, and frequently (both oral and written) Ability to exercise independent judgment in methods, techniques, and evaluation criteria for obtaining results Ability to act independently to determine methods and procedures Problem-solving skills and the ability to resolve issues as they arise Strong interpersonal skills, with the ability to assimilate with various cross-functional teams Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship or employment visas currently. NextPhase.ai is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Alexander Technology Group is looking for a Quality Engineer for a client based in the Portsmouth, NH area. This is full-time (perm) On-site in Portsmouth, NH Key Responsibilities: Develop and maintain quality systems for combination products. Ensure compliance with FDA, ISO 13485, cGMP, and other standards. Lead risk assessments, root cause analyses, and corrective actions. Oversee testing, validation, and documentation processes. Collaborate with R&D, manufacturing, and regulatory teams. Conduct training on QA practices and support continuous improvement. Perform inspections and product testing to ensure quality standards. Qualifications: Bachelor's in Engineering, Life Sciences, or related field. Strong knowledge of regulatory requirements and quality tools (e.g., Six Sigma, CAPA, FMEA). Excellent problem-solving and communication skills. Able to work independently in a small team environment. Preferred: Experience with design control, eQMS, and statistical tools. ASQ CQE certification. 3+ years in QA/QE roles with combination products. If interested, please send resume to ************************

Job Posting Start Date 11-03-2025 Job Posting End Date 01-31-2026 At JetCool, a Flex company, we're at the forefront of liquid cooling innovation, delivering advanced solutions that empower our partners in AI and high-performance computing. United by a shared purpose, our teams are pushing the limits of what's possible and tackling complex challenges. A career at JetCool offers the opportunity to make a real impact by helping build smarter, more sustainable data centers. Together, we're not just advancing technology - we're redefining cooling standards to create a more sustainable tomorrow. Job Summary JETCOOL Technologies is seeking an experienced Quality Manager in Littleton, MA to provide the analytics and guidance to effectively manage product and process quality for all JetCool products. Strong preference will be given to those who have designed and implemented total QMS systems in a start-up environment. JETCOOL Technologies is a fast-moving technology company spun out of MIT and now a member of the Flex family. Our technology provides game-changing cooling solutions for aerospace, electric vehicles, and data centers. Join us to be part of one of today's fastest growing industries, while having a positive impact on society sustainability through innovative technologies. What a Typical Day Looks Like: Develops, implements, and coordinates product assurance programs to prevent and eliminate defects in existing products and future new products Leads the creation and implementation of a comprehensive QMS system that identifies quality metrics and trends across the entire supply chain via customer field data leading to proactive management decision making Work with external suppliers, domestically and internationally to validate in-factory quality management tools, controls and reporting mechanisms. Integrate supplier quality data into JetCool quality control methods assuring timely and collaborative management of on-going product quality. Perform regularly scheduled on-site quality audits at key suppliers, assuring compliance with JetCool quality standards. Participates in, and work with Design Engineering during NPI development programs ensuring Design for Quality considerations are embedded in and validated the NPI release process Evaluates and leads the discovery of field return quality issues, drives root cause investigations, and recommends corrective actions Establish statistical process control measurement methods to gather product and process quality performance Acts as the point of contact for all internal and external quality issues across the supply chain (suppliers, raw stock, WIP, finished goods, warehouses, field deployments) The Experience We're Looking to Add to Our Team: 4-year college degree, masters preferred Minimum of 7-10 years relevant industry experience Experience working with fluid-mechanical systems consisting of fluids and pumps is preferred. Demonstrated experience building QMS management systems in partnership with global suppliers. Experience working with PLM and ERP systems. Experience working with Customers as a prime point of contact for fielded quality issues. Experience working with, integrating and converting product and process quality data into actionable information. Experience working with regulatory bodies (e.g. Nemko, UL, TUV, CSA) hosting factory audits and ensuring in factory controls are in place and up to date. Ability to travel to domestic and international suppliers, 10%-20% What you'll receive for the great work you provide: Full range of medical, dental, and vision plans Life Insurance Short-term and Long-term Disability Matching 401(k) Contributions Vacation and Paid Sick Time Tuition Reimbursement Pay Range (Applicable to Massachusetts)$107,900.00 USD - $148,400.00 USD AnnualJob CategoryQuality Is Sponsorship Available? No JetCool is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email accessibility@flex.com and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at JetCool, you must complete the application process first).

Grow with Welch's! Welch's is on a journey towards our bold ambition of being the global-leader of convenient, good for you fruit-based food and beverages. To turn this goal into a reality we need you and other exceptionally talented, agile, and innovative individuals who are eager to contribute to something extraordinary! At Welch's, we're not just offering a job; we're inviting you to be a part of a vibrant, authentic, and inclusive culture where you not only belong, but also have the opportunity to unleash the best, most authentic version of you. Position Summary: The Director of Food Safety and Quality (FSQ) at Welch's is responsible for providing strategic leadership and operational oversight of all FSQ programs to ensure the safety, quality, and regulatory compliance of our products. This role leads corporate FSQ initiatives, drives continuous improvement, and partners cross-functionally to embed a culture of food safety and quality across the business and supply chain. The Director will also manage the FSQ corporate team and play a critical role in shaping future policies, systems, and supplier partnerships. Where You'll Work: This role will be based out of our Waltham, MA headquarters where you will be immersed in a dynamic workplace where innovation thrives and collaboration is key. Our company in-office schedule is designed to maximize collaboration & relationship building balanced with flexibility and well-being with 3 days in office and Thursdays/Friday being remote, flex days. What You'll Do: Food Safety & Quality Programs * Lead the development, implementation, and continuous improvement of FSQ policies and procedures to ensure product safety, quality, and compliance with all regulatory and customer standards. * Support compliance with SQF, HACCP, FSMA, and related food safety certification and regulatory audit requirements. Packaging & Ingredient Quality * Own the Packaging and Ingredient Quality Programs, ensuring compliance with food safety standards, regulatory expectations, and internal quality targets. * Lead resolution of ingredient or packaging-related issues, including root cause analysis and corrective action planning. * Conduct on-site supplier audits and manage risk assessments, documentation, and supplier performance scorecards. System & Process Oversight * Oversee FSQ documentation systems, laboratory compliance, and integration of IT/enterprise systems that support quality management and traceability. * Drive digital transformation and system improvements to enhance decision making with improved data and drive overall efficiency. Cross-Functional Collaboration * Partner with R&D, Engineering, and Operations to align processes and requirements with ingredients, packaging, product, and processing specifications to support consistent execution. * Provide technical support and troubleshooting for food safety and quality at manufacturing sites as needed to ensure the highest quality and safest food reaches our consumers and customers. * Serve as a key advisor on FSQ risk assessments and design to ensure safe and high-quality product. * Foster strong, collaborative relationships across the organization to align FSQ priorities with business objectives. Leadership & Strategy * Coach and develop FSQ team members to strengthen organizational capability and foster a high-performance, quality-driven culture. Who You Are: * An experienced food safety & quality leader who can effectively work and influence in both a manufacturing plant and corporate environment * A proactive collaborator who plans and executes projects, gaining alignment and support across functions to deliver against strategic goals and day to day issue management. * A results-driven individual committed to delivering business impactful solutions. * Strong practical risk assessment skills with an ability to work under pressure and make decisions in a timely manner. * A strong team player who can work well in a dynamic environment and maintains a level of flexibility to support the broader team and deliver business results. * A person who is passionate about delivering consistent, high quality products to our consumers and customers that are safe and fully comply with all regulations. * Engages in healthy dialogue and makes decisions with Welch's best interest in mind. * Continuously changes the status quo and seeks ways to improve and develop. What You'll Need: Any equivalent combination of education and experience that proves competence in role may be considered. * 8 - 10 years combined experience in Corporate Food Safety or Quality Assurance, Plant Quality Assurance, and Plant Operations with demonstrated expertise managing food safety and quality initiatives in branded food products industry * B.S. required and preferred in Food Science, Engineering, Chemistry or Microbiology * Working knowledge of HACCP, FSMA, statistical process control, GMPs, CIP, sanitary design, and total quality management principles or techniques * Ability to travel 25% to 30% travel (project based, primarily domestic) What You'll Enjoy: * Organization with a bold, clear purpose & vision for the future * Inclusive Culture: Be a part of an inclusive workplace where you not only belong but also have the opportunity to be the best version of yourself * Passionate Community: You are encouraged to have a voice, share your opinions, and have individual impact on the success of the business * Hybrid work model: Flexible & collaborative work environment to maximize well-being & success * Paid Time Off and Holidays: Enjoy time away from the office to rest and recharge * Paid Volunteer Time Off: 40 hours of paid volunteer time for all non-union employees * Development & Advancement: Access to LinkedIn Learning as well as both formal and informal opportunities to develop and grow your career * Compensation Package Consisting of Competitive Base Salary and Annual Incentive Plan (Bonus) * 401K plan with Generous Company Match * Flexible Benefits from your first day: Choose the benefits that meet your needs and preferences o * Health, Dental & Vision Insurance * Health Savings Accounts * Life and accident insurance * Employee Assistance Programs * Tuition reimbursement program * Additional benefits available through Perks at Work * Paid parental (and adoption) leave - Available after 12 months of employment The anticipated hiring base salary range for this position is $185,000 to $195,000 annually for US-based employees. This range reflects the minimum and maximum for the position across all US locations, is based on a full-time work schedule, and is Welch's good faith estimate as of the date of this posting. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. In addition to base salary, this role is eligible for participation in a bonus plan. Welch's is an Equal Employment Opportunity Employer. We are committed to the prevention of employment discrimination based on race, religion, color, sex, gender identity, national origin, age, marital status, disability and/or military or veteran status, sexual orientation or any other action covered by federal or applicable state/local laws. Welch's offers more than just a job - it's an opportunity to grow, innovate, and make a global impact with a passionate community.

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.

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 ****************

Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology & oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. For more information, please visit ********************** Position Overview Prime Medicine is seeking a Quality Assurance (QA) Director to serve as the company's primary quality assurance expert across both clinical and nonclinical programs. This role will partner strategically with Clinical Development and Nonclinical functions to establish and maintain pragmatic, risk-based quality frameworks that ensure regulatory compliance and data integrity from early development through clinical execution. The ideal candidate brings hands-on QA experience in gene therapy modalities and a track record of sound judgment, collaborative decision making, and effective partnership with cross functional teams. The ideal candidate will be onsite 2-3 days a week in Watertown, MA. Quality Strategy & Governance Evolve and deliver the clinical and nonclinical quality strategy for Prime Medicine, embedding ICH E6(R3) and ICH M3(R2)/OECD principles from first-in-human through pivotal stages. Establish and maintain systems and processes (including SOP development) to improve the quality and compliance of both clinical and nonclinical studies, providing oversight and support to CRO GLP studies and internal non-GLP study activities in both the United States and Rest of World (ROW). Partner tightly with Nonclinical, Clinical Operations, CMC, and Regulatory teams to make risk‑balanced, time‑bound decisions that protect subjects and program timelines. Maintain and advance the phase‑appropriate Quality Management System (QMS) for GCP, applying proportionality to indication, phase, and patient risk. Provide input to and perform reviews of Deviation, CAPA, and Change Management records. Ensure data capture, management and analysis is fit for purpose, including audit trail reviews and software assurance approaches to satisfy 21 CFR Part 11/EU Annex 11 compliance requirements. Support or lead QA audits and inspections of clinical and nonclinical sites, vendors and studies, ensuring appropriate follow-up and CAPA closure. Contribute to the authoring, review, and revision of SOPs, templates, and procedural documents related to GLP and GCP activities. Nonclinical Study Oversight Ensure nonclinical study protocols are reviewed and approved on time, and that deviations from approved protocols are properly documented, evaluated, and reported. Implement systems and workflows to ensure that data in study reports are accurate, complete, and traceable through the ELN to raw data and animal subjects where applicable. Confirm that bioanalytical method qualification and validation studies are conducted in accordance with internal SOPs, ICH M10, and other applicable regulatory guidance. Review bioanalytical method reports for clarity, traceability, and data integrity from source data through final report. Serve as the quality assurance liaison to CROs conducting GLP studies, providing compliance oversight to ensure adherence to 21 CFR Part 58 and OECD GLP requirements. Clinical Study Oversight Lead implementation of ICH E6(R3) principles by integrating quality-by-design and Critical-to-Quality (CtQ) factors into study planning, execution, and monitoring. Conduct proportionate risk assessments and maintain defined Quality Tolerance Limits (QTLs) as appropriate to ensure participant safety and data reliability. Partner with CMC teams as needed to ensure ATMP GMP standards are maintained in accordance with the trial protocol, pharmacy manual(s) and related documents; use manufacturing quality knowledge (e.g., process validation) to support comparability assessments for clinical impact. Review critical study documents (e.g. clinical protocols, ICFs, monitoring plans, and other essential documents) to ensure compliance with applicable regulations, SOPs, and GCP guidelines. Ensure the maintenance of all QA documentation in the QMS and TMF, if applicable. Apply a risk-based oversight model that tailors monitoring, deviation management, and data governance to identified risks; ensure timely risk review, communication, and documentation of key quality issues and remedial actions. Partner with study teams on vendor selection/qualification; conduct audits, maintain the audit schedule, establish Quality Agreements and provide ongoing oversight of vendor performance. Provide coaching and just-in-time training to study teams and sites on product-specific GCP expectations. Receive, investigate, and escalate reports of potential scientific misconduct or serious breaches, ensuring appropriate root‑cause analysis, documentation, and regulatory reporting. Lead inspection readiness efforts as required. Chair/participate in mock inspections and interview training; storyboard key risks/issues and dossier positions; lead remediation sprints on identified gaps. Required Qualifications 10+ years in GCP/Clinical Quality Assurance, including 5+ years in cell & gene therapy; direct experience in gene editing modalities strongly preferred. Demonstrated success as a primary or sole QA lead supporting early-phase clinical and nonclinical programs. Deep, current knowledge of ICH E6 (R3), ICH M10, OECD GLP, and FDA/EMA expectations for CGT/ATMPs; practical experience bridging GCP-GLP-GMP interfaces. Proven decision quality under uncertainty and ability to influence program-level tradeoffs while maintaining compliance and scientific integrity. Hands-on leadership of audits (CROs, sites, specialty vendors, bioanalytical labs) and inspection readiness with successful outcomes. Excellent written and verbal communication; clear, concise reporting and executive level briefings. Preferred Qualifications Experience implementing RBQM, QTLs, and data driven quality metrics in CGT studies. ASQ CQA or equivalent auditor certification. The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus) and an annual long-term incentive award (e.g., equity). Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits-including medical, dental, vision, life insurance, a 401(k) match, and equity programs-along with generous paid time off, wellness days, and company-wide recharge breaks. Our commitment to employee well-being reflects our belief that when we care for our people, we strengthen our ability to put patients first and make meaningful impact together. U.S. Pay Range$207,000-$253,000 USD Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.

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.

Full-time Description To provide quality assurance and administrative supports to the day program management team, specifically to ensure the accuracy of documentation related to annual certification. PAY: $20/hr. Essential Responsibilities: Review daily and monthly documentation and billing for accuracy and compliance with state regulations Track and order building and office supplies Track, schedule and follow up on all van maintenance Monitor all building maintenance concerns and report to facility manager Train new hires on documentation systems Maintain certification files and execute annual certification review with state certifiers Qualifications: Education and Experience High school diploma or equivalent required 1-2 years' experience in the field of developmental services preferred Experience with writing and reviewing documentation for quality and accuracy in a human services setting preferred Proficiency in Microsoft Office Suite and database systems Valid driver's license and access to a safe operating vehicle during scheduled working hours Skills and Abilities Ability to work both independently and collaboratively as part of a team Maintains high attention to detail Strong computer literacy (including but not limited to proficiency with word processing, spreadsheets, email, and database software-MS Office) Ability to multi-task and meet deadlines under very specific timeframes Maintains a high level of organization Ability to communicate effectively (reading, writing, speaking) in English Strong customer services skills Ability to work well under pressure Note: The Moore Center considers the ability to speak, read and write English an essential functions of all positions. Training requirements, essential responsibilities and the physical requirements listed are considered essential to ensure the safety and well-being of the clients we serve. We will consider alternate methods of accomplishing tasks to accommodate any physical limitation(s) an employee might have. In an emergency, all staff may be required to perform activities that are above and beyond what is indicated on this job description to ensure the safety of the individuals we serve. All staff must adhere to the NH state law requiring mandated reporting of suspected abuse, neglect, or exploitation. Additionally, staff are required to maintain criminal, motor vehicle, DCYF, OIG, and Bureau of Elderly and Adult Services record checks that meet agency standards. Staff are also required to travel and transport clients when applicable. This includes having access to a reliable vehicle, a valid driver's license and maintaining comprehensive personal auto insurance of $100,000/300,000. Salary Description $20/hr.

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.

Immuneering is a clinical-stage oncology company outpacing cancer to help patients outlive their disease. Our lead product candidate, atebimetinib (IMM-1-104) is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. Immuneering's R&D team is based in a ~38,000 square foot lab and office facility in San Diego. The company also has offices in New York City and Cambridge MA. Immuneering has grown to more than 50+ employees, all working to apply their expertise, passion and creativity to improve the lives of people with serious diseases. Immuneering's team works collaboratively and relentlessly, thinking across traditional boundaries to help shape the frontiers of drug development. General Summary of Duties: The Director, Quality Assurance is a strategic leadership role responsible for overseeing key aspects of Quality within the organization including the development, implementation, and management of GxP (cGMP, GCP, and GLP) quality systems. To accomplish this, the candidate should have a strong knowledge of relevant regulations and be able to work cross-functionally to ensure compliance of Immuneering's ongoing development programs with local, state, federal, and international requirements. This position will be supportive in developing a culture of quality, ensuring compliance with global regulatory requirements, driving continuous improvement in quality systems, and supporting the successful development, manufacturing, and commercialization of pharmaceutical products. A successful candidate will be a highly collaborative individual with strong interpersonal skills and will be an exceptional team player. Specific Duties, may include but not be limited to the following: * Assist with developing, implementing, and maintaining GxP compliant quality systems and processes to ensure compliance with FDA, EMA, ICH, and global competent authority regulations and industry guidance * Co- lead quality audits, risk assessments, and investigations, ensuring timely resolution of quality issues. * Work with the company's external suppliers and contract organizations to ensure consistent quality and compliance. * Prepare for and manage inspections by regulatory agencies and commercial partners, serving as a liaison between the Company and auditors, including reporting and follow-up to any finding * Work on qualification and validation plans, assure proper batch releases and disposition. * Oversee resolution of any product concerns, including investigation, tracking and corrective action plans (CAPA) * Provide quality input on contracts and serve as a point person for negotiations of quality agreements. * Champion a culture of quality and continuous improvement across manufacturing and development operations. Desired Skills and Qualifications * Bachelor's degree in biological sciences or related field, with a minimum of 7 or more years experience in Quality Assurance or related fields within the pharmaceutical or biotechnology industry * Extensive knowledge of GxP (GMP, GLP, and GCP) regulations and guidelines, including FDA, EMA, and ICH requirements * Demonstrated hands on experience working on complex projects. * In-depth knowledge of FDA, EMA, and ICH guidelines, regulations, and processes related to CMC. * Strong partnering and communication skills required, as well as project management skills. * Must be focused on working collaboratively and within our values of: Data rules, All-in, Own it (Accountable), Caring and Humble. * Ability to work effectively in a collaborative, fast-paced environment. Pay scale: $175-210 annually, final offer to be commensurate with education and depth of experience, with potential for equity participation, bonus and comprehensive benefits. Location: Remote or Hybrid, if you live near an Immuneering office, regular Meet Ups are available. Physical Demands/ Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to 15% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.

InnoTECH Staffing is looking to hire a fulltime permanent Director of Regulatory Affairs & Quality Assurance (RA/QA) for an exciting and growing medical device company in Burlington, MA. Candidate must be local and be able to go to office a few days a week. Must be a US Citizen or Greencard Holder! Our client is a medical device manufacturer committed to advancing cancer therapy through research, engineering, high-quality products, and exceptional physician support. We are seeking a Director of RA/QA to lead all regulatory affairs and quality assurance activities for the company as they continue to expand their global presence and product portfolio. Job Description · Lead, manage, and develop the Regulatory Affairs and Quality Assurance functions to ensure organizational compliance with global medical device regulations and standards. · Oversee the development, implementation, and continuous improvement of the company's Quality Management System (QMS) in accordance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory frameworks. · Direct internal GMP/QSR audits and manage external audits from regulatory agencies, notified bodies, and key customers. · Lead the preparation, submission, and maintenance of device regulatory submissions including EU MDR Technical Documentation, 510(k) applications, FDA listing/registration, and international market authorizations. · Oversee and ensure compliance with complaint handling, medical device reporting (MDR/Vigilance), field corrections/recalls, and import/export regulatory requirements. · Direct the creation, execution, and maintenance of internal and supplier quality audits; ensure suppliers meet regulatory and company quality expectations. · Oversee product and process validation programs, including IQ/OQ/PQ activities, ensuring that products are consistently manufactured to specifications and compliant with regulatory expectations. · Provide strategic regulatory input for new product development, design changes, and lifecycle management activities. · Serve as the primary liaison with regulatory authorities, notified bodies, and external partners regarding regulatory and quality matters. · Lead RA/QA daily operations including CAPA management, risk management activities (ISO 14971), document control, training, and quality metrics reporting. · Advise executive leadership on regulatory strategy, quality trends, risk factors, and compliance status to support business objectives. Education / Experience Requirements · Bachelor's degree in a scientific or engineering discipline; advanced degree preferred. · 8+ years of experience in FDA and EU medical device Regulatory Affairs and Quality Assurance, with demonstrated expertise in global regulatory requirements and quality system standards. · Minimum of 5 years of medical device quality assurance experience with strong working knowledge of ISO 13485 and FDA QSR. · Experience in preparing and managing regulatory submissions (e.g., 510(k), EU MDR) and supporting regulatory audits/inspections. · Excellent organizational, leadership, interpersonal, and communication skills. · Demonstrated success in a hands-on, fast-paced, cross-functional medical device environment. Specialized Skills / Other Requirements · Strong understanding of risk/benefit analysis, product safety principles, and regulatory science applicable to interventional medical devices. · Proven ability to effectively manage multiple complex projects and enforce timelines in a growing organization. · Strong technical writing skills and the ability to create clear, compliant regulatory and quality documentation. · Ability to collaborate across departments including R&D, Manufacturing, Operations, Clinical, and Marketing. · 10% to 25% travel may be required for audits, regulatory meetings, and supplier visits. · Self-starter with excellent attention to detail and the ability to follow through on commitments. Full-time position with competitive compensation, medical/dental insurance, 401(k), and professional development opportunities.

Job Details Bournewood Hospital - Brookline, MA Full Time Bachelors Degree $115000.00 - $125000.00 Salary Regular 8:00 am to 5:00 pm QA - Quality ControlDescription The Quality Assurance and Compliance Director is responsible for developing, implementing, and maintaining the hospital's Quality Assessment and Performance Improvement (QAPI) and Compliance Programs. This position ensures the hospital meets and exceeds standards established by regulatory and accreditation agencies, including The Joint Commission (TJC), the Massachusetts Department of Mental Health (DMH), the Bureau of Substance Addiction Services (BSAS), and the Centers for Medicare & Medicaid Services (CMS). This role works collaboratively with the Chief Nursing Officer, Director of Facility Operations, CEO, and other department leaders to coordinate data-driven quality assurance activities, regulatory compliance functions, and survey preparedness. The position promotes continuous regulatory readiness, supports the hospital's Quality Improvement (QI) Plan, manages incident reporting and patient safety initiatives, and provides education and consultation to staff and leadership regarding compliance and risk standards. The Director provides leadership, coordination, and oversight of all quality and compliance activities, supporting the organization's mission to provide safe, effective, and patient-centered behavioral healthcare. Essential Duties and Responsibilities Program Development & Oversight Develop, implement, and manage the hospital's QAPI and Compliance Programs in alignment with regulatory and accreditation standards. Ensure the integration of quality and compliance activities into all levels of the organization. Ensure risk management, patient safety, and compliance data are integrated into QI reporting. Maintain documentation for accreditation readiness (Joint Commission, CMS, BSAS, DMH), including Measures of Success, FMEAs, and audit tools. Coordinate and lead Quality and Compliance Committees, and co-lead Patient Safety Committee. May co-lead other committees as assigned. Regulatory & Accreditation Compliance Ensure ongoing readiness for TJC, DMH, BSAS, and CMS surveys and inspections. Serve as primary liaison during all regulatory surveys, audits, and inspections. Monitor changes in laws, regulations, and standards, and update hospital policies and practices accordingly. Performance Measurement & Reporting Collect, analyze, and report data related to clinical outcomes, patient safety, and performance indicators. Conduct root cause analyses, identify trends, and facilitate corrective action planning. Provide regular quality and compliance reports to hospital leadership and the Governing Body. Education & Training Develop and deliver staff education on quality improvement, patient safety, and compliance standards. Support department leaders in understanding and applying regulatory and accreditation requirements. Risk Management & Incident Oversight Oversee the hospital's incident reporting, investigation, and follow-up processes. Ensure timely reporting to regulatory agencies when required. Collaborate with leadership on risk reduction strategies. Policy Development & Review Maintain and review hospital policies and procedures for regulatory alignment. Ensure timely policy updates and staff notification. Communication Demonstrates professionalism, clarity, and respect in all forms of communication. Communicate effectively with staff, leadership, patients, and regulatory agencies. Maintains open, collaborative communication across departments to support transparency and teamwork. Demonstrates appropriate communication and composure in challenging or high-pressure situations, including when addressing compliance findings, staff concerns, or regulatory interactions. Provides constructive feedback and education to staff in a supportive and solution-focused manner. Ensures communication of quality and compliance data is accurate, timely, and easily understood by diverse audiences. Key Performance Indicators (KPIs) 100% of required regulatory reports submitted within mandated timelines. 100% of policies reviewed and updated per scheduled cycle. No Condition-level findings during regulatory surveys. 90% of incident reports investigated and closed within set timeframe. Evidence of ongoing performance improvement initiatives documented in QAPI reports. Compliance Responsibility Adheres to all hospital policies and procedures. Ensures compliance with all applicable standards, including TJC, DMH, BSAS, and CMS. Maintains confidentiality in accordance with HIPAA and hospital standards. Reports any suspected violations of compliance or safety standards immediately. May act as Privacy Officer and assist in HRO complaint resolutions. Competencies Knowledge of behavioral health care delivery systems. Commitment to ethical practice and patient rights. Ability to work collaboratively across interdisciplinary teams. Strong problem-solving, decision-making, and leadership skills. Capacity to manage confidential information with discretion. Qualifications Licensure: Current Massachusetts licensure as a Registered Nurse (RN), Licensed Practical Nurse (LPN), or Licensed Independent Clinical Social Worker (LICSW) required. Education: Bachelor's degree in Nursing, Social Work, Health Care Administration, or related field required; Master's degree preferred. Experience: Minimum of three (3) years of progressive experience in quality management, regulatory compliance, or performance improvement in a healthcare setting. Experience in psychiatric or behavioral health strongly preferred. Knowledge/Skills: Comprehensive knowledge of The Joint Commission (TJC), Massachusetts Department of Mental Health (DMH), Bureau of Substance Addiction Services (BSAS), and Centers for Medicare & Medicaid Services (CMS) standards and reporting requirements. Strong analytical, organizational, and project management skills. Ability to interpret regulations and accreditation standards and translate them into practice. Excellent written, verbal, and interpersonal communication skills. Proficiency in Microsoft Office Suite and data reporting systems.

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.

Country: United States of America Onsite U.S. Citizen, U.S. Person, or Immigration Status Requirements: U.S. citizenship is required, as only U.S. citizens are authorized to access information under this program/contract. Security Clearance: None/Not Required Pratt & Whitney is working to once again transform the future of flight-designing, building and servicing engines unlike any the world has ever seen. And because transformation begins from within, we're seeking the people to drive it. So, calling all curious. Come ready to explore and you'll find a place where your talent takes flight-beyond the borders of title, a country or your comfort zone. Bring your passion and commitment and we'll welcome you into a tight-knit team that takes our mission personally. Channel your drive to make a difference into shaping an organization and an industry that's evolving fast to the future. At Pratt & Whitney, the difference you make is on display every day. Just look up. Are you ready to go beyond? What You Will Do: The North Berwick Supplier Quality Clinic is a challenging, fast paced, and high visibility environment. The Supplier Quality Clinic Manager will manage the Quality Clinic with a high level of integrity to effectively manage cross-functional relationships to drive and support a high performing team. Leadership of the Supplier Quality team focused on Quality Improvement and flawless execution of the Quality Clinic process Responsible for timely and compliant ownership and resolution of all Escapes Management Investigations and actions to include issuance and closure of escapes, requesting 6015s when required, requesting IROs as necessary and follow up through closure, and verification of implementation of escape corrective actions to due date(s); maintain oversight of the organization's Escape Management Process Responsible for timely and compliant ownership and resolution of Customer Returns Investigations and other clinic to clinic investigations. Present details of Escapes and providing updates to Quality and Ops leadership and Customers as required, including the DCMA. Manage timely processing of restricted inventory; support Metrics and Control Tower reporting activities Maintain personal and team CORE discipline certifications/training Optimize the Quality Clinic's efficiency and robustness; foster and maintain cooperative relationship with Program Quality, Product Recall, DCMA, and leverage clinic to clinic interaction across the enterprise; enhance personal and team competency in RCCA Support Production Tier 4 & 5 Gemba - Manufacturing Standard Work: Collaborate with shop quality, engineering support to operations, materials, procurement, and other plant leadership / stakeholders. Qualifications You Must Have: Bachelor's degree and minimum 8 years experience in an engineering, manufacturing operations, quality or closely related industrial environment or a Master' degree and minimum 5 years experience in an engineering, manufacturing operations, quality or closely related industrial environment In absence of a degree, 12 or more years experience in an engineering, manufacturing operations, quality or closely related industrial environment Experience in a team lead/supervisory capacity Experience with the Escapes Management Process and Quality Clinic Process Understanding of Root Cause/Corrective Action (RCCA) Experience with Microsoft Excel, PowerPoint, and SAP U.S. citizenship is required, as only U.S. citizens are authorized to access information under this program/contract Qualifications We Prefer: Experience creating and delivering presentations Certification in Red-X / 6 Sigma / similar data driven problem solving approach preferred Demonstrated ability to manage customer concerns, process commitments and meeting customer deliverables Learn More & Apply Now: In addition to transforming the future of flight, we are also transforming how and where we work. We've introduced role types to help you understand how you will operate in our blended work environment. This role is: Onsite: Employees who are working in Onsite roles will work primarily onsite. This includes all production and maintenance workers, as they are essential to the development of our engines. As part of our commitment to maintaining a secure hiring process, candidates may be asked to attend select steps of the interview process in-person at one of our office locations, regardless of whether the role is designated as on-site, hybrid or remote. The salary range for this role is 101,000 USD - 203,000 USD. The salary range provided is a good faith estimate representative of all experience levels. RTX considers several factors when extending an offer, including but not limited to, the role, function and associated responsibilities, a candidate's work experience, location, education/training, and key skills.Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, flexible work schedules, employee assistance program, Employee Scholar Program, parental leave, paid time off, and holidays. Specific benefits are dependent upon the specific business unit as well as whether or not the position is covered by a collective-bargaining agreement.Hired applicants may be eligible for annual short-term and/or long-term incentive compensation programs depending on the level of the position and whether or not it is covered by a collective-bargaining agreement. Payments under these annual programs are not guaranteed and are dependent upon a variety of factors including, but not limited to, individual performance, business unit performance, and/or the company's performance.This role is a U.S.-based role. If the successful candidate resides in a U.S. territory, the appropriate pay structure and benefits will apply.RTX anticipates the application window closing approximately 40 days from the date the notice was posted. However, factors such as candidate flow and business necessity may require RTX to shorten or extend the application window. RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act. Privacy Policy and Terms: Click on this link to read the Policy and Terms