Quality manager jobs in Worcester, MA

Title: Quality Systems & Investigations Specialist Employment Type: Contract Status: Accepting Candidates About the role This position plays a key role in supporting daily manufacturing activities by resolving operational issues and driving high-quality investigations. The role ensures process reliability through strong technical oversight and collaboration with critical operations teams. Key Responsibilities • Lead real-time floor support, triaging deviations and initiating root cause investigations. • Produce thorough, compliant quality documentation for deviations, CAPAs, and impact assessments. • Partner with manufacturing, QC, facilities, and materials teams to define corrective and preventive actions. • Apply structured scientific thinking to evaluate data and support operational decisions. • Contribute to process improvement by identifying trends and proposing optimized workflows. Qualifications • 6+ years experience in pharma/biotech manufacturing environments. • Proven background in investigations, RCA, QC analytics, and GxP documentation. • Skilled in cross-functional coordination and rapid issue assessment. • Strong analytical mindset with the ability to interpret complex data sets. • Experience supporting manufacturing operations in fast-paced, regulated environments. Compensation (MA Pay Transparency): • Estimated hourly range: $50-$58/hr (W-2). • Final rate within this range will be based on skills, experience, and interview results.

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 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.

🚀 Contract Opportunity - Quality Engineer (Edifecs Project) 📍 Remote (U.S.-based only) | 💼 7-Month Contract | 💰 W2 Only We're looking for experienced Quality Engineers to join a remote Edifecs project within the U.S. healthcare domain. This is a 7-month W2 contract opportunity with a leading healthcare technology team. Key Responsibilities Review business requirements and data mappings related to the HealthRules Payor ecosystem. Perform manual testing, create and execute test cases, and document results. Design or contribute to comprehensive testing plans. Conduct SQL-based validation and data analysis. Collaborate with technical and business teams to ensure data accuracy and functional integrity. (Optional) Contribute to testing automation or agentic testing initiatives. Required Skills & Experience Strong background in U.S. Healthcare systems and processes. Hands-on experience with HealthRules Payor and HealthRules Data Warehouse. Proficiency in SQL for validation and data testing. Demonstrated experience creating and executing manual test cases. Excellent attention to detail, documentation, and communication skills. Must be authorized to work in the U.S. (W2 only) and reside within the United States. Nice to Have Familiarity with Edifecs integration and testing frameworks. Exposure to automation or agentic testing tools. 📩 Interested? Apply today to join a dynamic remote team working on a transformative U.S. healthcare project.

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).

WHOOP is an advanced health and fitness wearable on a mission to unlock human performance and healthspan. We empower our members to improve their health and perform at a higher level through a deeper understanding of their bodies and daily lives. As the Director of Regulatory Affairs & Quality Assurance (RA/QA), you will lead the strategy, execution, and continuous evolution of WHOOP's regulatory and quality frameworks as we expand deeper into regulated digital health and medical-grade product capabilities. You will also play a critical role in strengthening WHOOP's design quality discipline, ensuring robust design controls, risk management, and design quality practices. You will shape the regulatory pathway for our next generation of health features, ensure compliance across global markets, and build systems that enable WHOOP to scale medical device development responsibly and efficiently. This role is ideal for a seasoned RA/QA leader who thrives in fast-paced, cross-functional environments and is motivated by the opportunity to help define the future of WHOOP as a health technology company.QUALIFICATIONS: Lead regulatory strategy for WHOOP's health features and regulated products from development through approval and lifecycle management. Oversee regulatory submissions including 510(k), De Novo, technical files, global registrations, providing strategic direction, final review, and cross-functional alignment. Serve as WHOOP's primary liaison with regulatory agencies and notified bodies. Interpret and communicate regulatory requirements to cross-functional teams, ensuring seamless integration throughout the development lifecycle. Oversee WHOOP's Quality Management System (QMS) to ensure compliance with FDA, ISO 13485, MDR, and other global regulatory frameworks. Provide leadership and oversight for Design Quality Engineers responsible for DHF maintenance, design reviews, risk management (ISO 14971), verification/validation strategy, and software change control processes. Lead internal and external audit readiness, including FDA inspections and notified body audits. Manage post-market surveillance and adverse event reporting. Review marketing and promotional materials for regulated and general wellness features to ensure compliance. Build, manage, and mentor a high-performing team. Monitor regulatory changes, evolving standards, and industry trends, advising leadership on implications and opportunities. RESPONSIBILITIES: Bachelor's degree in life sciences, engineering, regulatory affairs, or a related field; advanced degree preferred. 8+ years of regulatory affairs experience in medical devices, digital health, wearables, or related fields. Proven experience leading successful FDA submissions (510(k), De Novo) and managing global regulatory approvals. Demonstrated success building or overseeing a Quality Management System, including experience with external audits. Deep understanding of software as a medical device (SaMD), cybersecurity considerations, post-market requirements, and applicable standards. Strong working knowledge of ISO 14971 risk management, including hazard analysis, FMEAs, risk/benefit justification, and integration of risk controls across hardware, firmware, and software. Experience overseeing post-market quality activities, including complaints, MDR/Vigilance assessments, field actions, and design updates based on post-market signals. Working knowledge of privacy and data regulations such as HIPAA and GDPR. Exceptional communication, leadership, and stakeholder management skills. Ability to thrive in a fast-paced, high-growth environment with evolving priorities. Experience navigating the boundary between general wellness and SaMD, including evaluating feature intent, regulatory risk, and appropriate evidence pathways. It is strongly preferred that the candidate is able to work out of the WHOOP office located in Boston, MA. Interested in the role, but don't meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply. WHOOP is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. The WHOOP compensation philosophy is designed to attract, motivate, and retain exceptional talent by offering competitive base salaries, meaningful equity, and consistent pay practices that reflect our mission and core values. At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company's long-term growth and success. The U.S. base salary range for this full-time position is $220,000-$245,000. Salary ranges are determined by role, level, and location. Within each range, individual pay is based on factors such as job-related skills, experience, performance, and relevant education or training. In addition to the base salary, the successful candidate will also receive benefits and a generous equity package. These ranges may be modified in the future to reflect evolving market conditions and organizational needs. While most offers will typically fall toward the starting point of the range, total compensation will depend on the candidate's specific qualifications, expertise, and alignment with the role's requirements. Learn more about WHOOP .

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.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH). Essential Functions * Independently conduct audits * Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits * Facilitate Sponsor health authority inspections of global clinical facilities and study sites * Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs * Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies. * May be responsible for direct people management including goal setting, performance management, development, and engagement. Requirements * Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. * 5+ years of experience in GCP auditing. * Substantial experience in inspection management. * Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials. * Demonstrated ability to operate and influence decision-making processes * Effective communication skills * Successful track record of supervising employees and managing cross-cultural differences * Technical and administrative capabilities to independently carry out routine, complex and for-cause audits * Knowledge of data integrity controls and systems quality for clinical area * Strong analytical skills and report writing skills * Experience with GxP systems including computer system validation and associated regulations, recommended. * Ability to Travel (approximately 20%) * Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities. Eisai Salary Transparency Language: The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit *********************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

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.

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.

Supplier Quality Manager FLSA Status: Exempt Are you ready to embark on an exhilarating journey with a team that's passionate about making a difference? Pharmaron is thrilled to invite you to join us as our newest Supplier Quality Manager at our Coventry, RI facility! If you're craving a role that offers challenges, growth, and meaningful impact, then this is the opportunity you've been waiting for. Job Overview: Pharmaron's Coventry site is seeking an experienced Supplier Quality Manager to lead QA activities related to suppliers, materials, receiving, and warehousing. This role also provides support for QA functions in manufacturing and equipment qualification. This is an excellent opportunity for a self-motivated and driven professional to contribute to a dynamic and growing organisation within the pharmaceutical sector. What You'll Be Doing: Supplier Qualification & Management Maintain the site's supplier and service provider qualification programme, including contract labs Act as QA point of contact for supplier deviations and corrective actions Manage quality agreements and maintain Approved Supplier Lists Review and document supplier change notices Ensure supplier documentation is up to date Host the Vendor Assurance Committee and lead QA assessments for new materials and suppliers Write and assess material specifications and vendor assurance reports Perform risk assessments and collaborate with development teams on use test requirements Auditing & Inspections Conduct supplier audits Support internal audits, client audits, and regulatory inspections Quality Systems & Projects Lead cross-functional teams for major investigations using site tools Ensure procedures are phase-appropriate for clinical Phase 1 through commercial API manufacturing Contribute to the implementation of an ERP system for warehouse and procurement systems Manufacturing & Equipment Qualification Coordinate product release activities including batch record review and analytical data receipt Support equipment cleaning and qualification processes Client Development Support Assist with client quality agreements Help develop and track Key Performance Indicators (KPIs) with clients What We're Looking For: A Bachelor's degree in Chemistry, Engineering, or a related scientific discipline Minimum 6 years of QA experience in a CMO/CDMO environment focused on API manufacturing Strong understanding of phase-appropriate quality systems (from clinical Phase 1 through commercial API) Experience in regulatory and client interactions, including inspections and audits Proven ability to host audits and support regulatory inspections Solid knowledge of ICH guidelines (especially ICH Q7) and CFR regulations Familiarity with ERP systems and Quality Management Systems such as TrackWise Excellent communication and collaboration skills Why Pharmaron? Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China. Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators. Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package: Insurance including Medical, Dental & Vision with significant employer contributions Employer-funded Health Reimbursement Account Healthcare & Dependent Care Flexible Spending Accounts 100% Employer-paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance 401k plan with generous employer match Access to an Employee Assistance Program How to Apply: Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today! As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.

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

The Ryan White Dental Program (RWDP) is a comprehensive dental access program for persons living with HIV/AIDS in Massachusetts and Southern New Hampshire, funded under Ryan White Part A and with funds from the Massachusetts Department of Public Health. Services funded are recruitment of dentists and preventive, diagnostic and therapeutic services rendered by licensed dentists and dental hygienists. Under the supervision of the Director of the Ryan White Dental Program , the Clinical/Quality Management Program Manager of RWDP will be responsible for clinical quality improvement, reviewing eligibility for clients accessing services; providing technical and monitoring assistance to assure dental vendors attain contracted goals & objectives; monthly reporting of program activities; maintaining consistent contact with dental providers and other parties as needed; and working collaboratively with program & fiscal staff to ensure system accountability. Responsibilities Review dental treatment plans and history to determine appropriate options for people living with HIV (PLWH) seeking dental care to be reimbursed by the program Provide initial review of dental claims, including client eligibility, dental billing codes, and prior approvals Review past billing and client dental records to prevent duplicate or improper billing for services Monitor monthly prior approval expenditures and assist in reconciliation of payments in coordination with other Dental and BPHC fiscal staff With the assistance of other RWDP staff, review and update annual Scope of Services documents for dental contracts, including client eligibility, fee schedules, and other requirements With the assistance of other RWDP staff, develop and update a Standard Operating Procedures (SOP) manual, including policies and procedures for Dental staff, vendors, and clients; the client enrollment process; recruitment of vendors; and reimbursement process for dental services. Draft and revise quality management plan for the program, including tracking of health and quality of life indicators, dental standards of care, and quality improvement activities Conduct regular research into the most current dental best practices and disseminate such content to a diverse audience, including HIV service providers and clients Provide support on presentations to both internal and external stakeholders on the impact of services on the oral health care needs of PLWH Regularly attend programmatic meetings Handle communication with clients, dental providers, and others Perform other duties as required

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Location/Division Specific Information Reporting to the Plainville, MA site and supporting the Viral Vector Services (VVS), a division of Thermo Fisher Scientific. At VVS, we deliver from process development through commercial supply, offering the expertise and resources vital to help clients deliver innovative gene therapies. We are placed at the forefront of our leading and groundbreaking Cell and Gene Therapy business, enabling clients to cure genetic, rare, and otherwise untreatable diseases. Discover Impactful Work: The Manager, Quality Control Bioanalytical & Analytical Transfer provides leadership and scientific and technical expertise for bioanalytical QC and transfer activities at the Plainville, Massachusetts site. These activities include the timely qualification of in-process and release testing of toxicological, clinical, and commercial grade biopharmaceuticals, qualification/validation of analytical methods for support of cGMP manufacturing, and the transfer and validation of assay methods from clients and/or Assay Development & Analytics to the cGMP QC testing laboratory. The manager ensures cGMP compliance, operates within budgets, and supervises bioanalytical lab staff directly and QC scientists and technicians indirectly. Responsibilities include hiring, training, goal setting, and performance evaluation. The manager collaborates with departments and project teams for planning and timelines, improves QC services, and maintains safe working conditions. Additionally, the manager serves as the primary technical liaison with clients. A Day in the Life: Lead all aspects of and drive the Bioanalytical lab operational readiness plan to ensure on-time approval of analytical equipment and test methods needed for GMP testing. Build a trained, competent team of QC analysts to support GMP testing. Coordinate daily Quality Control activities for Molecular, Viral, Cell, and Tissue Culture operations and contract testing. Ensure compliance, accuracy, and timeliness of testing processes. Lead the introduction of new technology, equipment, methodologies, and validations. Provide QC leadership and support across the VVS organization. Facilitate cross-functional communication and ensure all testing processes, metrics, and departmental goals are achieved. Strive to implement and improve systems and drive efficiency throughout the organization. Support internal, external, and regulatory inspections as needed. Hire and develop employees within the department. Assign work, coach staff, and take vital disciplinary actions. Serve as primary QC Bioanalytical contact for regulatory inspections and client audits. Provide support for method qualification and validation from Assay Development and Analytics and/or clients. Support the establishment and/or enhancement of QC and operational metrics. Provide frequent overall departmental feedback to senior management. Ensure adequate staffing is hired and trained. Keys to Success:Education BS required, MS preferred in a scientific/technical field. PhD in a scientific/technical field is a plus. Experience 6-8 years of experience in a quality position within the biological and/or pharmaceutical industry required. Significant experience in supporting functional areas (e.g., PD, Manufacturing, QA, Engineering, EHS) preferred. Experience with writing Deviations, Lab investigations, and OOS required; experience with Root Cause Analysis required. 2-3 years experience leading teams in a fast-paced environment required. Experience with regulatory inspections from the FDA, EMA, Health Canada, or other regulatory authorities required. Knowledge, Skills, Abilities Capable of writing reports, business correspondence, and procedure manuals. Strong organizational skills; ability to prioritize and lead through complex processes/projects. Ability to read, analyze, and interpret business periodicals, common scientific, professional, and technical journals, financial reports, governmental regulations, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to employees, top management, public groups, and/or boards of directors. Ability to interpret and carry out an extensive variety of technical instructions in written, oral, schedule, mathematical, or diagram form. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to apply principles of logic or scientific thinking to a wide range of intellectual and practical problems. Able to lead abstract and concrete variables in situations where only limited standardization exists. Benefits We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

The Company Meridian Adhesives Group is a rapidly growing, full service global adhesive solutions provider, specializing in adhesive technologies used in electronics, industrial, and infrastructure applications. Fueled by a series of strategic acquisitions since its formation in 2018, Meridian has established itself as an adhesive technology leader for a broad, global, blue-chip customer base comprised of OEMs, distributors, and industrial clients with an expanding global footprint. Summary The Quality Control (QC) Manager operates within an ISO 9001-certified Quality Management System to ensure our products' facilities, methods, processes, and procedures conform to both Company and customer requirements. The Quality Control Manager organizes department workflow, coordinating daily activities of the lab while interacting with the Production Supervisor and other departments to manage priorities. This role ensures Product compliance to internal and customer specifications; and supports continuous product and process improvements through collection, analysis, and reporting of test results. Duties & Responsibilities Manage Quality Control laboratory in compliance with ISO 9001 standard. Publish regular reports on product and process quality by collecting, analyzing, and summarizing data and trends. Interface with Company's suppliers to promote beneficial relationships based on continuous improvement. Supervise a team of Laboratory Technicians in Meridian's Billerica, MA and Cranston, RI facilities. Organizes daily laboratory routine and workflow based on facility needs. Provides guidance, training, and skills development to QC employees. Ensure that all facility equipment and instruments are properly calibrated and maintained. Troubleshoot and repair instruments. Schedule outside equipment vendor services as needed. Maintain service contracts of key laboratory instruments and equipment. Coordinate outside calibration vendors as needed. Manage stocks of key laboratory consumable supplies. Operate QC laboratories in compliance with all applicable federal, local and Company safety regulations and policies. Maintain and understand all relevant laboratory procedures. Maintain Company's documentation and certification to MIL-STD-883 adhesive standard. Performs other related duties as assigned. Skills & Abilities Excellent verbal and written communication skills. Excellent organizational skills and attention to detail. Strong time management skills with a proven ability to meet deadlines. Strong analytical and problem-solving skills. Proven history of effective collaboration on multi-disciplinary teams. Education & Experience Bachelor's degree, science preferred. Two to three years' experience as a QC Supervisor or Manager. Experience working within an ISO 9001 or equivalent quality system. Experience with chemical or adhesives manufacturing preferred. Experience with reporting of quality metrics. Experience with SPC reporting perfred. Experience with measuring and testing equipment. Knowledge of safety requirements and legal standards for laboratory operations. Experience with Microsoft Office suite required. Experience with ERP, Project Management, SPC and Analytics software preferred. Physical Requirements Prolonged periods of sitting at a desk and working on a computer. Must be able to lift up to 15 pounds at times. The company is an Equal Opportunity Employer, drug-free workplace, and complies with ADA regulations as applicable. *No 3 rd Party Recruiters/Agencies Pay: This position has a salary range of $109,000 - $121,000.00. The salary range represents the expected range for this position. The actual salary may vary based upon several factors, including, but not limited to, relevant skills/experience, time in the role, business line, and geographic location. Bonus Pay: Meridian offers a performance-based incentive plan tied to company success. Eligible employees have the opportunity to earn a percentage of their salary, with bonus payments distributed yearly. Benefits: 401(k) matching Health insurance Vision insurance Dental insurance Flexible spending account Health savings account Life insurance STD & LTD Paid time off Parental leave Referral program *No 3 rd Party Recruiters Why Join US Meridian is a leading name in the adhesives industry, renowned for delivering innovative solutions and exceptional service to clients worldwide. Guided by our core values - Safety & Sustainability, Respect, Integrity, Accountability, and Teamwork - we are driven to make a meaningful impact in everything we do. When you join Meridian, you become part of a dynamic team that values diverse perspectives, fosters professional growth, and encourages bold ideas. We're committed to creating a supportive environment where you can thrive, grow, contribute to groundbreaking projects, and help shape the future of our industry. Check out our website! ************************************** Meridian Adhesives Group is an Equal Opportunity Employer. We are committed to creating an inclusive workplace and do not discriminate based on race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, veteran status, or any other protected status under applicable law. We maintain a drug-free workplace and comply with the Americans with Disabilities Act (ADA) by providing reasonable accommodations to qualified individuals with disabilities.

WHO WE ARE RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people's lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science. THE ROSLINCT WAY Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people's development, growth, and the ability to impact patients. ACCELERATING YOUR FUTURE The Quality Control Senior Manager, Flow Cytometry & Molecular is responsible for providing daily management of lab operations (people, process, product) within Quality Control, with focus on in-process and product testing for cell products with analytical methods such as cell based assays, qPCR, dPCR, dd PCR, ELISAs, flow cytometry and related methods. This position provides scientific support to the QC group and partner project teams during technology transfer, analytical method qualification, and routine GMP testing. This role will spend time in the laboratory educating and training staff and executing assays and part time collaborating with Analytical Development and partner representatives. This position is highly visible in the organization and requires the ability to interface with multiple groups, and the ability to assess method suitability, interpret results, perform tasks independently, and troubleshoot. How You Will Make an Impact: Select, develop/train, manage and evaluate QC staff to ensure site objectives are met. Manage sampling plans and testing schedules for Client product, including the management of outsourced testing. Support the implementation of new QC methods, including equipment acquisition, method procedure, and qualification protocol development. Support the QMS elements related to QC (deviations, CAPA, change control) as needed to support Client production. Operate and maintain flow cytometer and PCR instrumentation (e.g FACSLyric). Perform immunostaining for multi-color flow assays and generate, analyze and interpret flow cytometry data. Provide scientific guidance, training, and support for method transfers/qualification/validation and routine testing of in-process, final product, and stability samples. Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner. Review all data in accordance with applicable procedures and cGMP requirements. Author, review, and/or approve SOPs, Test Methods, and other procedures required to operate a QC laboratory. Anticipate and troubleshoot problems. Communicate effectively with management regarding task completion, roadblocks, and needs. Work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects. Communicate effectively with cross-functional peers, department management, and partner representatives. Other duties as assigned. What You Will Bring: Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire team to achieve project goals. Build a culture based on company values. A highly organized work style that ensures timely execution of tasks. A mindset that ensures accurate results. Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint). Effective problem-solving capabilities. Strong oral and written communication skills. Qualifications: Bachelor's Degree in scientific discipline. 10+ years cGMP biotech/pharmaceutical Quality Control, including laboratory experience. Minimum 5 years leadership experience as a Manager, Senior Scientist or as a Team Lead. Thorough knowledge of cGMP/ICH/FDA regulations Ability to independently prioritize/manage activities for self and direct reports. Proficient in MS Office applications and information technologies that support documentation and data management systems. Strong troubleshooting and problem-solving skills. Excellent oral and written skills. Ability to multi-task and interact with multiple groups in a team-oriented environment. WORKING CONDITIONS Monday-Friday, 1st shift (e.g., 8am-5pm). Flexible shift work including weekends. May be required on occasion in support of 24/7 manufacturing operations. PHYSICAL REQUIREMENTS Job will require ability to lift up to 25 pounds, stand for extended periods of time, and complete repetitive tasks. OUR COMMITMENT All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. RoslinCT is proud to be an equal-opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.

WHO WE ARE RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people's lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science. THE ROSLINCT WAY Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people's development, growth, and the ability to impact patients. ACCELERATING YOUR FUTURE The Quality Control Senior Manager, Flow Cytometry & Molecular is responsible for providing daily management of lab operations (people, process, product) within Quality Control, with focus on in-process and product testing for cell products with analytical methods such as cell based assays, qPCR, dPCR, dd PCR, ELISAs, flow cytometry and related methods. This position provides scientific support to the QC group and partner project teams during technology transfer, analytical method qualification, and routine GMP testing. This role will spend time in the laboratory educating and training staff and executing assays and part time collaborating with Analytical Development and partner representatives. This position is highly visible in the organization and requires the ability to interface with multiple groups, and the ability to assess method suitability, interpret results, perform tasks independently, and troubleshoot. How You Will Make an Impact: Select, develop/train, manage and evaluate QC staff to ensure site objectives are met. Manage sampling plans and testing schedules for Client product, including the management of outsourced testing. Support the implementation of new QC methods, including equipment acquisition, method procedure, and qualification protocol development. Support the QMS elements related to QC (deviations, CAPA, change control) as needed to support Client production. Operate and maintain flow cytometer and PCR instrumentation (e.g FACSLyric). Perform immunostaining for multi-color flow assays and generate, analyze and interpret flow cytometry data. Provide scientific guidance, training, and support for method transfers/qualification/validation and routine testing of in-process, final product, and stability samples. Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner. Review all data in accordance with applicable procedures and cGMP requirements. Author, review, and/or approve SOPs, Test Methods, and other procedures required to operate a QC laboratory. Anticipate and troubleshoot problems. Communicate effectively with management regarding task completion, roadblocks, and needs. Work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects. Communicate effectively with cross-functional peers, department management, and partner representatives. Other duties as assigned. What You Will Bring: Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire team to achieve project goals. Build a culture based on company values. A highly organized work style that ensures timely execution of tasks. A mindset that ensures accurate results. Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint). Effective problem-solving capabilities. Strong oral and written communication skills. Qualifications: Bachelor's Degree in scientific discipline. 10+ years cGMP biotech/pharmaceutical Quality Control, including laboratory experience. Minimum 5 years leadership experience as a Manager, Senior Scientist or as a Team Lead. Thorough knowledge of cGMP/ICH/FDA regulations Ability to independently prioritize/manage activities for self and direct reports. Proficient in MS Office applications and information technologies that support documentation and data management systems. Strong troubleshooting and problem-solving skills. Excellent oral and written skills. Ability to multi-task and interact with multiple groups in a team-oriented environment. WORKING CONDITIONS Monday-Friday, 1st shift (e.g., 8am-5pm). Flexible shift work including weekends. May be required on occasion in support of 24/7 manufacturing operations. PHYSICAL REQUIREMENTS Job will require ability to lift up to 25 pounds, stand for extended periods of time, and complete repetitive tasks. OUR COMMITMENT All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. RoslinCT is proud to be an equal-opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.

General Description: The Construction Quality Control Manager (“CQCM”) is responsible to develop and oversee and support field-based quality efforts for all JR Vinagro construction projects. CQCM provides support by reviewing specifications and developing project specific quality plans, inspection and test plans, providing guidance on quality questions, assisting with quality audits, and attending project meetings. The Regional Quality Manager provides oversight for JRV project field staff and third-party quality and/or inspection personnel. This role reports to the Vice President of Construction and interacts with stakeholders within Project Management, Estimating, Business Development, Field Operations, clients, consultants, and vendors. Core Responsibilities Develop and implement a comprehensive field quality management system across all projects. Guide field staff on quality standards to drive compliance with industry and contract requirements. Work VP of Construction and Construction Manger to enhance company quality documentation. Provide Quality Control 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. Interface with Owners to clarify acceptability of project quality plans and assist with identification of quality incident solutions, RFI responses, and NCR responses. 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 noncompliance and work with management to educate and remediate. Qualifications BA in engineering or related discipline or equivalent work experience in the construction industry with specific quality control experience 5-10 years as construction quality control manager or representative Must be detail-oriented, organized, flexible, and able to effectively multitask while working in a fast-paced environment. Excellent time management and prioritization skills to ensure deadlines are met while providing accurate deliverables. Strong working knowledge of Microsoft Office (Excel, Word, Power Point, and Outlook) Preferred Qualifications Strong understanding of Quality Control and Assurance practices for Civil Infrastructure / DOT and Airport construction projects. OSHA 30 Certification ASQ Quality Inspector, NETTCP Certification, Concrete ACI Certification or other professional certifications. Strong field construction experience - successful candidates will understand construction sequencing, durations, dependencies, production, and the time and cost implications of failures. Background knowledge of construction industry QA/QC practices and standards. Benefits Competitive base salary, commensurate with experience Vehicle / transportation allowance healthcare plus dental & vision. 401k plus company match up to 5%. JR Vinagro is an equal opportunity employer

Job Description Neurotech Pharmaceuticals, Inc. is a private biotech company located in Cumberland, RI and Needham, MA, within the realm of Greater Boston's vast biotechnology landscape. Since our inception more than 20 years ago, our focus has been on developing and commercializing transformative therapies for chronic eye diseases. The core platform technology, Encapsulated Cell Therapy (ECT), is a first-in-class drug delivery platform designed to slow the progression of chronic eye diseases. Neurotech's first commercial product, ENCELTOTM (revakinagene taroretcel-lwey), is approved in the United States for the treatment of adults with idiopathic Macular Telangiectasia Type 2 (MacTel). Encapsulated cell-based gene therapy is designed to provide long-term, sustained delivery of therapeutic proteins for the treatment of chronic eye diseases. The Manager, Quality Control Microbiology & Environmental Monitoring (EM), is responsible for leading all microbiological quality control programs at Neurotech, including oversight of environmental monitoring, sterility assurance, endotoxins, and mycoplasma testing programs. While certain compendial assays are performed by external contract laboratories, this position ensures method oversight, data review, and vendor compliance with GMP requirements. This role serves as the site subject matter expert (SME) for microbiology and contamination control and provides strategic and technical leadership across multiple product streams. The Manager will mentor and develop a growing Microbiology team, ensuring operational excellence, inspection readiness, and the highest standards of data integrity and GMP compliance in support of Neurotech's clinical and commercial manufacturing operations. Job Requirements Lead and oversee the Environmental Monitoring (EM) program, including viable and non-viable particulate monitoring, surface sampling, personnel monitoring, utility gases, purified water, and trending/reporting of results. Manage internal Microbiology laboratory operations, ensuring GMP compliance, data integrity, and timely execution of testing to support manufacturing and release activities. Serve as SME for microbiology, sterility assurance, and contamination control across Neurotech manufacturing and support areas. Provide oversight and technical review for outsourced compendial testing (e.g., bioburden, Microbial IDs, dose audits, mycoplasma, etc.) performed by contract testing organizations (CTOs). Develop and maintain microbiological control strategies for aseptic processing areas, including management of EM limits, deviation investigations, and contamination trend analyses. Author, review, and approve technical documentation, including SOPs, EM plans, protocols, and technical reports. Support site audits and regulatory inspections/responses as the primary Microbiology & EM representative. Partner cross-functionally with Manufacturing, Facilities, and Quality Assurance to maintain a robust contamination control program. Provide mentorship, coaching, and daily leadership to Microbiology & EM analysts; establish training and competency plans for the team. Participate in risk assessments, root cause analyses, and CAPA development related to microbiological or environmental events. Support site efforts through timely design, validation, and execution of studies, protocols, reports, etc. Identify and drive continuous improvement initiatives to enhance testing efficiency, data integrity, and contamination control systems. Education & Experience Bachelor's or Master's degree in Microbiology, Biology, Biotechnology, or related life science. 8-12 years of progressive experience in GMP Quality Control Microbiology, including direct experience managing Environmental Monitoring programs. Strong working knowledge of compendial microbiological methods (e.g., USP , , , , , , , , etc.), aseptic techniques, and contamination control principles. Demonstrated experience leading or overseeing Microbiological testing (e.g., sterility, endotoxins, mycoplasma, etc.). Proven track record in team leadership, mentorship, and technical development of laboratory staff. Comprehensive understanding of GMPs (21 CFR 210/211/820/ISO 13485), aseptic manufacturing, and cleanroom behavior. Excellent written, verbal, and interpersonal communication skills with the ability to interact effectively across departments. Prior experience supporting biologics, cell therapy, or gene therapy manufacturing strongly preferred. Knowledge, Skills & Abilities Technical and Regulatory Expertise in Microbiology & EM Leadership and Team Mentorship Data Integrity and GMP Documentation Excellence Contamination Control Strategy and Risk Assessment Continuous Improvement and Problem-Solving Orientation Do you share our vision? Applications are currently being accepted through the Neurotech Career Center. Neurotech Pharmaceuticals provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.