Quality manager jobs in Manchester, NH

Discover Veranova: At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference. Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation. Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients. Role Overview: This role provides Quality Assurance (QA) support for bioconjugation processes and GMP manufacturing of APIs and intermediates, ensuring compliance with global quality standards and regulatory requirements. This role will oversee key quality activities including deviation management, change control, batch record review, and product disposition, while driving continuous improvement and compliance initiatives. As a leader within the Quality Operations team, the QA Supervisor will guide and develop team members, collaborate across functions, and shape the strategic direction of quality within the organization. Core Responsibilities: Lead Quality Assurance oversight for bioconjugation manufacturing, ensuring GMP production and release of conjugated APIs, linkers, and payloads meet client expectations, timelines, and quality standards. Provide hands-on QA support on the production floor during conjugation, purification, and filling operations to ensure compliance with cGMPs, SOPs, and company policies. Oversee the review and approval of deviations, change controls, CAPAs, batch records, specifications, and other controlled quality documentation. Coach, mentor, and develop QA staff, providing guidance on quality systems, compliance practices, and real-time problem solving. Drive operational excellence by aligning local QA initiatives with global objectives and promoting a culture of quality and compliance across the organization. Support audits, investigations, and regulatory inspections, ensuring timely follow-up and continuous improvement in processes and systems. Evaluate complex quality or cross-functional issues using a risk-based approach and ensure CDMO partners meet Quality Agreement and regulatory expectations. Prioritize and allocate QA resources effectively to meet business demands and production schedules. Serve as a key client interface for Quality topics, fostering strong relationships and clear communication on regulatory and quality matters. Contribute to organizational quality strategy by participating in forums, continuous improvement initiatives, and talent development efforts. Qualifications: Required Minimum 9 years of quality assurance (QA) experience in a GMP manufacturing setting, preferably within a CDMO or API/intermediate facility, with an undergraduate degree in engineering, science or related field; or a minimum 7 years of QA experience with a graduate degree in engineering, science or related field Proven leadership experience in pharmaceutical, API/intermediate, medical device, biologics or related FDA industry Demonstrated proficiency and knowledge of cGMP, ICH, and other US and worldwide regulatory requirements Working knowledge of US & EU GMP, ICH Q7 and Part 11 compliance Proven ability to drive complex projects from initiation to completion, with strong analytical, problem-solving, and attention-to-detail skills. Demonstrated experience working effectively both independently and in team settings, including prior people management or team leadership. Excellent communication, interpersonal, networking, presentation, and influencing skills to build and lead cross-functional relationships. Embodies and promotes Veranova's culture, fostering an inclusive, positive work environment and delivering exceptional business results. Strong collaborative mindset with the ability to motivate, develop, and inspire others while effectively managing priorities and responsibilities. Preferred Direct experience with bioconjugation processes (e.g., linker/payload attachment, conjugated intermediates) is strongly preferred. Familiarity with HPAPI handling and containment requirements a plus Certified Lead Auditor certificate, or certification(s) in Lean manufacturing methods/tools such as structured problem solving, Lean Six Sigma, etc. Salary Range: $125,000 - $140,000 annual base salary Our Commitment: Health & Wellness: Comprehensive health & wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies. Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors. Final compensation may vary depending on experience, skills, education, and business needs. Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs. Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We welcome people with diverse experiences and perspectives who share our mission to improve and save lives. Even if you don't meet every qualification, we encourage you to apply. Veterans, first responders, and those transitioning from military to civilian life bring valuable skills that strengthen our team. Additional Information: Applicants for this role must be authorized to work in the United States without further employer sponsorship. Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting. All your information will be kept confidential according to EEO guidelines. Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law. All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice .

About the job Title: Quality Systems Specialist Employment Type: Contract Duration: 6+ months Status: Accepting Candidates About the Role We're hiring a Quality Systems Specialist to support global Quality Systems operations for a leading biopharmaceutical manufacturing organization. This role is heavily focused on documentation, training, system governance, and validation support within a regulated GxP environment. Key Responsibilities Support Quality Systems operations to ensure compliance with SOPs and regulatory requirements (FDA, EMA, ICH) Assist with governance of Quality System applications, including harmonization across sites Gather and document system requirements through workshops and meetings with SMEs and process owners Participate in user forums to collect, prioritize, and triage enhancement requests and system issues Initiate, manage, and complete change controls, including required documentation Maintain systems in a validated state (user access reviews, change management, deviation & CAPA support) Support investigation, escalation, and resolution of system-related issues Execute validation activities, including requirements gathering, validation planning, IQ/OQ support, test scripts, execution, discrepancy management, and validation reporting Provide system administration, user onboarding, and training support Qualifications Experience supporting Quality Systems in a biopharma / pharmaceutical / life sciences environment Strong background in documentation-heavy roles (SOPs, training materials, change controls) Hands-on experience with change management, deviations, and CAPA Familiarity with validated systems and GxP compliance Exposure to QMS tools (e.g., TrackWise, Veeva, MasterControl) is strongly preferred Strong communication skills and ability to work cross-functionally Compensation (MA Pay Transparency) Estimated hourly range: $40-$50/hr (W-2) Final rate within the posted range will be based on skills, experience, and interview results

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess' patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world. The 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 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.

Aerospace & Defense Quality Engineer - 6-Month Contract The Quality Engineer will be responsible for the development, implementation, maintenance, and continuous improvement of quality assurance processes in a regulated aerospace and defense environment. This role requires a strong data-driven mindset and hands-on quality engineering expertise to ensure compliance with AS9100/ISO standards, customer requirements, and regulatory obligations. Responsibilities Identify, analyze, and resolve quality issues using structured problem-solving methodologies Perform loss reporting and drive continuous improvement initiatives Design and implement process control, process improvement, testing, and inspection methods Develop, execute, and analyze quality metrics and reporting to support data-driven decision-making Perform and review First Article Inspections (FAI) in accordance with AS9102 requirements Interpret and apply GD&T per ASME Y14.5 to support inspection planning, nonconformance resolution, and root cause analysis Ensure compliance with AS9100 and applicable ISO standards across manufacturing and inspection processes Support and participate in internal, customer, and third-party quality audits Collaborate cross-functionally with engineering, manufacturing, and supply chain teams to ensure quality requirements are met throughout the product lifecycle Qualifications Bachelor's degree in Mechanical, Electrical, Manufacturing Engineering, or a related field (or equivalent experience) 4+ years of quality engineering experience in aerospace, defense, or another regulated manufacturing environment Strong working knowledge of AS9100, ISO 9001, and aerospace quality system requirements Experience performing and reviewing First Article Inspections (AS9102) Proficiency in interpreting engineering drawings and GD&T per ASME Y14.5 Strong knowledge of industry quality tools (e.g., SPC, FMEA, root cause analysis, CAPA) Demonstrated analytical, data-driven approach to problem solving Strong communication, documentation, and audit-support skills To learn more or apply, please contact me at ****************************. BioTalent Ltd is acting as an employment agency in relation to this opportunity.

Global Quality Manager (CBS) Green, Nashua, Mexicali, Nantong, Hanoi) Amphenol Cable Backplane Systems (CBS) operates at an extreme pace with rapid growth, driven by the global AI hardware infrastructure expansion. As the leading supplier of complex cabled backplane systems, CBS enables next-generation data center performance for technology titans. Our solutions involve thousands of twin-ax subassemblies packaged into custom mechanical assemblies with tightly controlled electrical and mechanical specifications. CBS supports customers from early concept development through full-scale datacenter deployment, ensuring reliability and precision at every stage. The CBS team is looking for a Global Quality Manager. The Global Quality Manager will lead the end-to-end global Quality strategy for Cable Backplane Systems (CBS), ensuring product and process quality across NPI and volume manufacturing, driving customer satisfaction, and reducing field returns through robust prevention, detection, and continuous improvement. Key Responsibilities Strategy & Governance: Define the global Quality Management System (QMS), policies, and KPIs (FPY, DPPM, RMA rate, audit scores). Standardize across sites and suppliers. Customer Quality: Own customer quality interface; lead executive reviews; align on quality agreements and purge/replacement plans; oversee PCNs and SQE engagement. NPI Quality: Embed APQP/PPAP, CTQs, and gated readiness in new programs; drive process capability (Cp/Cpk), measurement systems (MSA), and qualification (DQ/IQ/OQ/PQ). Manufacturing Quality: Deploy SPC, layered process audits, mistake-proofing, and rapid containment; run weekly global quality reviews; ensure compliance to regulatory/industry standards. Problem Solving: Institutionalize 8D root cause and corrective action; lead cross-functional FA on top issues. Supplier Quality: Set SQE/PPM targets; qualify second sources; manage incoming quality and change control (PCNs). Digital Quality: Scale AI vision and analytics playbooks for in-factory reliability and inline detection; build dashboards for real-time quality health. People & Culture: Build and mentor a high-performing global quality team; develop succession and training (SPC, 8D, MSA, FMEA). Qualifications: BS in Engineering (EE/ME/IE) required; MS/MBA preferred. 10-15+ years in Quality leadership across multi-site, high-mix electronics manufacturing (connectors/cables/EMS/semiconductor adjacent). Deep expertise in APQP, PPAP, SPC, MSA, FMEA, DOE, reliability and FA (metrology, microscopy, environmental/electrical tests). Proven track record with Tier-1 customers and ramp/scale scenarios; strong program and stakeholder management. Ability to travel globally (25-40%).

Job Description 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.

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 of QA GMP Operations is responsible for management of GMP quality within our external manufacturing operations globally and internal GMP operations for development and commercial programs. The Director will also work closely with internal business stakeholders as well as internal Quality function to deliver outcomes to advance programs within compliance. The Director is responsible for oversight of QA activities and ensuring the quality of deliverables within the role's purview. This is an onsite role based in Waltham, MA. Primary Responsibilities Include: * Management of external quality operations in support of GMP manufacturing (clinical and commercial) activities. * Manage deviations, OOS and OOTs investigations while adhering to cGMP principles and ICH guidelines. * Review batch records, analytical method reports and technical reports including regulatory sections of IND/IMPD and BLA/MAAs. * QA support of Tech Transfer and Process Validation activities. * Disposition of GMP batches and interfacing with the Qualified Person (QP). * Change management to ensure proper evaluation of manufacturing and testing related changes by Quality, Regulatory, and Subject Matter Experts. * Manage CDMO performance within Quality Agreement expectations and GMP compliance. * Drive continuous improvement and inspection readiness. * Collaborate cross functionally to ensure pre-approval inspection and commercial readiness activities are completed at the CDMOs and internally. * Adjudicate on compliance discussions and negotiate any required corrective actions. * Create and foster a culture of collaboration and engagement for advancing quality outcomes and operational excellence. Education and Skills Requirements: * Minimum of a BA/BS degree * Minimum of 10+ years of experience in GMP Quality Operations in a clinical late stage and/or commercial biotechnology company * Leadership experience managing cross-functional teams with an ability to influence teams to prioritize activities and allocate resources without direct authority * Experience implementing and utilizing various outsourcing and support models * Experience with disposition of product batches and interfacing with a Qualified Person (QP) * Excellent written and oral communication skills, including well-developed presentation skills * Excellent organizational skills and ability to manage multiple priorities * Strong collaboration and interpersonal skills to effectively interact with internal or external stakeholders at all levels in the organization * General business management knowledge to assess the impact of project decisions on financial and corporate objectives * Ability to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities * Embrace Dyne's core values and culture #LI-Onsite MA Pay Range $188,000-$230,000 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.

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. 90% of this role is internal and external audits, dealing with findings, CAPAs, updating procedures, returns, non conformities. 10% new submissions / regulatory approval in countries outside the US. 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.

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.

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.

Quality Control Manager - Cambridge, MA Successful and growing Cambridge-Based Company with a strong Social and Environmental commitment to producing one of the finest food products in the world is currently looking for a passionate, motivated Quality Control Manager to join our Operations Team.The Company has acustomer base that includes all types of business serving every food consumer market with distribution extending coast to coast and overseas. The QC Manager will be responsible for ensuring Food Safety Compliance and Quality Assurance for the Company and its products. This is a Managerial role that involves overseeing and directing, as well as training, developing all employees in Company Quality and Hygiene Standards. The QC Manager will be accountable for all departmental reports and the successful completion of Food Safety and QualityAssurance audits. Responsibilities: ¨ Ensure strict compliance within all local and Federal Food Safety Standards. ¨ Assist with implementation and adherence to consistent Production standards and delivery of High Quality Food Products. ¨ Facilitate and coordinate efficient and effective Quality Standards to ensure Customer satisfaction. ¨ Develop employees through proper training, monitoring, mentoring, and performance reviews. ¨ Promote Teamwork across Departments to ensure High Quality Output and Customer satisfaction and retention. ¨ Ensure adherence to all Health and Safety Regulations and consistently maintain a safe working environment. ¨ Analyze Process Control Charts, develop Quality Control Plans and inspect system design. ¨ Review and respond to Customer feedback with strict emphasis on both the Company and customer's best interest. ¨ Communicate and collaborate with Sales and Plant Operations teams regarding Quality Program Management, testing requirements, and inspection coordination. ¨ Develop and implement Internal QA Systems to support Company growth. ¨ Remain current on trends and changes affecting Food Safety to ensure Program Compliance under Government and Company Regulations. ¨ Communicate with Upper Management regarding QA and Food Safety issues and plausible solutions. ¨ Conduct and complete Audits and associated Reports with timeliness and accuracy. ¨ Maintain thorough records of Food Quality Reports, Tests, and Inspections. ¨ Other Duties as assigned. Requirements: ¨ Bachelor's Degree in Biology, Microbiology, Food Science, Animal Science, Quality Assurance or a related field. ¨ Strong Technical knowledge of Quality Assurance and Food Safety. ¨ Familiarity with Regulatory Agencies. ¨ Knowledge of GMP and GMP Audits. ¨ 3-7 years of experience in Quality Assurance/Control within Food Industry or Food Safety Leadership. ¨ Strong Managerial Skills, including hiring, training and development, scheduling, discipline, and retention of staff. ¨ Excellent Written and Oral Communication Skills. ¨ In depth knowledge of HACCP, FDA, and SQF/GFSI requirements. ¨ Ability to think independently, as well as demonstrate strong Organizational, Planning, Implementation, and Execution Skills. ¨ Personable, professional, and productive within a team environment. ¨ Desire to consistently learn and be challenged. ¨ Ability to work in a fast paced and rapidly changing environment. No Phone Calls or Recruiters please. Equal Opportunity Employer

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team. Bristol Myers Squibb is seeking a Manager, QC Analytical, Molecular at the Cell Therapy Facility (CTF) in Devens, MA. This role will manage the daily operations of the QC Analytical shift, responsible for QC bioanalytical testing and data review for in-process, release, and stability testing of clinical and commercial cell therapy drug product. The Manager, QC Analytical will also be responsible for hiring, mentoring and developing the QC Analytical team to support business operations and employee career development. Schedule: Wed-Sat 6am-4pm Responsibilities: Supervise the QC Analytical lab staff on shift and oversee the daily lab activities related to in-process, final release, and stability testing of cell therapy drug product. Develop and execute a work plan for the shift, ensuring safety, quality, and performance targets are achieved. Perform QC data review ensuring results are compliant with specifications and regulations. Report abnormalities. Track, trend, and report key performance metrics. Drive continuous improvement in the lab to increase productivity and efficiency. May collaborate with other departments to identify and implement process improvements. Review and approve test methods and procedures to ensure operational alignment and compliance with corporate policies and procedures. Own and evaluate relevant change controls, investigations, deviations, CAPAs. Hire, mentor, and develop team members to support the business operations and employee career development. Oversee training of the team members. Communicate effectively with management regarding task completion, roadblocks, and needs. Responsible for cGMP compliance in all aspects of laboratory operations. Participate in site team supporting and managing regulatory inspections and findings. Perform other tasks as assigned. Additional Qualifications/Responsibilities Knowledge, Skills, Abilities: Experience with various bioanalytical techniques (cell-based assays, ELISA, qPCR, flow cytometry) and associated equipment. Experience with laboratory LIMS, ELN, and ERP systems (e.g., SAP) preferred. Ability to work in a highly regulated environment and follow regulatory requirements and GMPs. Ability to mentor associates, manage multiple assignments while meeting timelines in a GMP environment. Advanced ability to work collaboratively in a high-paced team environment, meet deadlines, and prioritize work from multiple projects. Excellent organizational and critical thinking skills. Advanced problem-solving ability/mentality, technically adept and logical. Advanced ability to communicate effectively with peers, department management, and cross functional peers. Proficient with Excel, Visio, PowerPoint, and other common software applications. The incumbent will be working around biohazardous materials. Minimum Requirements: Bachelor's degree required, preferably in Chemistry, Microbiology or related science. 6+ years of relevant laboratory work experience, preferably in a regulated environment. 2+ years of management and people leader experience. An equivalent combination of education and experience may substitute. Compensation Overview: Devens - MA - US: $99,380 - $120,428 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

* Guide field staff on BOND quality standards to drive compliance with industry and client requirements. * Work with Project Management Director to enhance company quality documentation. * Support company efforts in working toward ISO:9001 certification. * Participate in and assist with Quality training for Project Team members. * Work collaboratively with Project Management team to draft detailed Project Specific Quality Plans, Inspection and Test Plans, and Quality Checklists. * Ensure methods and procedures for recording, evaluating, and reporting quality and reliability data are followed and executed by field staff. * Assist pursuit teams in developing quality plan language and budgets for proposal submissions when required. * Interface with clients to clarify acceptability of project quality plans and assist with identification of quality incident solutions, RFI responses, and NCR responses. * Effectively and efficiently prioritize and manage competing tasks and deliverables. * Establish and maintain relationships with third-party vendors for inspection and testing services. * Identify Critical Quality Control activities that may impact the project and critical path. * Visit project sites and develop observation reports to identify quality issues pertaining to document control and any gaps in program adherence. * Proactively identify and report issues of non-compliance and work with management to educate and remediate. * Work with Project Management Director on continuous improvement opportunities.

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.

Armitage Architecture, Inc. (Armitage), provides multidiscipline engineering, technical, management and professional services to federal, commercial and private sectors. Our mission is to provide our clients with professional services utilizing innovative technologies and proven management systems. Primary Function The Individual will need to be able to perform as a Site Supervisor or Quality Control Manger. The individual will primarily be working on our Army clients projects. Depending on the size of the project the individual will serve as either the Site Supervisor or Quality Control Manager. Site Supervisor Responsibilities: Coordinate and manage all on-site activities, work with project teams including Corporate Project Managers, Project Engineers, Foreman, and Field Personnel and other office departments, to deliver successful projects to owners, on time and on budget with a high level of quality. Quality Control Manager (QCM) Responsibilities: The QCM is responsible for identifying inventory and order quality, identifying and recommending operational process improvements, conducting random sampling and preparing quality control documents. Ensure compliance with design documents through field inspections and reviews. Site Supervisor Key Responsibilities Ensure all required materials, equipment, and inspections occur to support the project schedule. Responsible for site safety. Ensure the overall jobsite is safe for workers and visitors as well as manage compliance with established company safety policies. Work with the project teams to budget, forecast, and manage field personnel as well as management of labor, equipment, materials, tools, and other cost considerations. Prepare work plans and develop temporary facilities for the project. Understand, review, and manage project plans, specifications, and manufacturer's data and execute project based upon said documentation. Manage the overall project and 3 week look ahead schedules, including creating the master schedule and updating it on a weekly basis. Generate RFI's (Requests for Information) as required to ensure completeness of the project documents and identifying and clarifying any discrepancies. Review submittals for compliance with project manual and plans, manufacturer's recommendations and code, or other standards applicable to the system. With the project team to manage the company's quality control program for the project. Conduct preconstruction planning. Conduct on-site project meetings with subcontractors and construction trades lead personnel. Manage subcontractors for all work performed on-site. Manage site work and logistics of construction site. Management and supervision of work crews on-site including… a. Mentor and train field personnel. b. Manage foreman and their duties and ensure all have resources and information to perform their tasks effectively and efficiently. c. Provide performance evaluations of field personnel. d. Manage the overall safety of the project and ensure all personnel have resources to perform their work safely. Quality Control Manager Key Responsibilities Act independently as CQC while coordinating all QC functions so as not to delay construction scheduling Read and understand specifications, reference codes and standards. Review and interpret contract drawings. Review provisions that have been made to provide required control inspection and testing. Prepare QC submittal plan for project. Efficient management of project submittals. Check to assure all materials and or equipment have been tested, submitted and approved. Examine the work area to assure that all required work has been completed and is in compliance with the contract requirements and resolve any differences. Determine, communicate, and document deficiencies and ensure they are corrected in a timely manner. Communicate with client and their representatives in a clear and understandable manner about all status updates. Conduct required meetings with all interested parties. Perform daily checks to assure control activities, including testing/compliance, and document all results. Produce a daily report, to be included in project manager's daily report Conduct all completion inspections - punch-out, pre-final and final acceptance. Maintain current records providing factual evidence that required quality control activities and/or tests have been performed Skills Professional style of verbal and written communication Strong organizational skills and exceptional attention to detail Motivated, self-starter who works well independently or as a team Builds positive working relationship with peers and colleagues