Quality manager jobs in Pawtucket, RI

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 ****************** .

🚀 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.

Must Have Technical/Functional Skills • Knowledge on Quality Management and its tools & techniques • Knowledge about GMP (Good Manufacturing Practices), FDA, ISO 13485 and compliance regulations • Knowledge on Medical Device Regulatory Standards, MDD and MDR • Knowledge on NC, CAPA, Root Cause Analysis and Audit processes • Knowledge on Validation process, writing protocols/ reports • Very good understanding/ experience in writing procedures, product specs and work instructions • Knowledge in Statistics, Risk Management and Design control • Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills • Experience in creating FMEAs & Writing reports • Experience in PMS (Post Market Surveillance) • Experience in PLM Tool (Windchill) • Good understanding of Design, Drawing and GD&T • Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred • Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software • Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.) Roles & Responsibilities • Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, the duties and responsibilities for this position are: • Development and review of PDP (Product development Process) deliverables • Review and approve R&D/ Engineering protocol/ reports • Development of Risk management records (i.e. DFMEA/ PFMEA) in collaboration with SMEs • Support and provide guidance on Validations and if required write Validation Protocols/ Reports • Support/ Remediation of Validation/ Quality Documentation • Support Root Cause Investigation and closure of NC and CAPA • Review and approve the Change Orders (CR/ CN) • Review and update the design/ process control documents like procedures/ work instructions/ product specs etc. • Work with cross functional teams and internal teams to create deliverables • Performs other duties assigned as needed Salary Range: $90,000 $95,000 Year TCS Employee Benefits Summary: Discretionary Annual Incentive. Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans. Family Support: Maternal & Parental Leaves. Insurance Options: Auto & Home Insurance, Identity Theft Protection. Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement. Time Off: Vacation, Time Off, Sick Leave & Holidays. Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.

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.

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.

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

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.

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.

As a leading financial services and healthcare technology company based on revenue, SS&C is headquartered in Windsor, Connecticut, and has 27,000+ employees in 35 countries. Some 20,000 financial services and healthcare organizations, from the world's largest companies to small and mid-market firms, rely on SS&C for expertise, scale, and technology. Job Description Job Title: Director of QA Locations: Boston, MA or Windsor, CT | Hybrid Get To Know Us: We are a fast-paced, dynamic team, who are leaders in technology and responsible for developing, maintaining, implementing, and expanding our next-generation platform for insurance companies. Singularity is a cloud-based, AI-powered platform for insurers and investment managers that provides integrated accounting, operational processing, and advanced analytics for all asset types. Why You Will Love It Here! Flexibility: Hybrid Work Model and Business Casual Dress Code, including jeans Your Future: 401 (k) Matching Program, Professional Development Reimbursement Work/Life Balance: Flexible Personal/Vacation Time Off, Sick Leave, Paid Holidays Your Wellbeing: Medical, Dental, Vision, Employee Assistance Program, Parental Leave Wide Ranging Perspectives: Committed to Celebrating the Variety of Backgrounds, Talents, and Experiences of Our Employees Training: Hands-On, Team-Customized, including SS&C University Extra Perks: Discounts on fitness clubs, travel, and more! What You Will Get To Do: The Director of QA is responsible for defining and executing a consistent and repeatable process for full product testing, deployment, and release for Insurance software solutions. The Director must have strong leadership and planning skills and be able to manage both large and small projects through an iterative lifecycle model. Ensures that products meet end-user functional and design requirements as well as performance and scale expectations through the execution of software quality tests. Defines and executes integration, performance, regression, and/or acceptance testing. Develops and supports the test automation environment for executing software quality tests. Leader with broad operational or functional responsibilities who participates with other senior leaders or executives to establish and ensure the achievement of strategic plans and objectives. Demonstrates in-depth company knowledge, specialized skills, and influence to solve critical and complex issues. Participates in the development and administration of broad-scope programs and projects that have a significant impact on operational or functional success. The Director will manage a team across multiple locations and will be responsible for defining and executing the test strategy, maintaining a build environment throughout the iterative development cycle, and building the final release of the product to deliver to market. The incumbent for this role will: • Define and maintain project plans to manage delivery schedule, resource management, task tracking, and status reporting through testing and release phases of projects • Define and execute a consistent, repeatable process for QA • Maintain an efficient, high-quality library of scripts for automated testing • Deliver a clear release-to-market certificate for all product releases • Maintain reliable infrastructure to support source control, build, and release environment • Deliver a reliable and repeatable deployment model for all products • Manage day-to-day task assignment and team member workload • Manage progress and status for a cross-functional team across multiple projects • Establish SMART goals and career development for team members and review/reset as necessary What You Will Bring: Candidates must have led product QA organizations with oversight over the parts of the software development process that involve QA testing and release readiness, and have experience with SaaS software applications in the financial services sector. 10-15 years of experience in the financial industry 10 years in a QA leadership position A candidate should have extensive experience implementing the testing and QA approach as applied to a business or a product Candidate must have planning and presentation skills The Candidate must have strong leadership abilities and the ability to provide direction Education: B.A. or B.S. required Thank you for your interest in SS&C! If applicable, to further explore this opportunity, please apply directly with us through our Careers page on our corporate website @ ************************ Salary range for the Position is expected between $150,000.00 and $175,000.00. The successful candidate may be eligible for an annual discretionary incentive compensation award. #LI-DS3 #LI-HYBRID Unless explicitly requested or approached by SS&C Technologies, Inc. or any of its affiliated companies, the company will not accept unsolicited resumes from headhunters, recruitment agencies, or fee-based recruitment services. SS&C offers excellent benefits including health, dental, 401k plan, tuition and professional development reimbursement plan. SS&C Technologies is an Equal Employment Opportunity employer and does not discriminate against any applicant for employment or employee on the basis of race, color, religious creed, gender, age, marital status, sexual orientation, national origin, disability, veteran status or any other classification protected by applicable discrimination laws.

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

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.

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

Interested in an outstanding opportunity to become part of a team with a stellar reputation as a community engaged Employer of Choice? Established well over a century ago, the Company has grown over the last 100-plus years from a local fourth generation family business into one of the largest construction managers and general contractors in the Northeast and Mid-Atlantic regions. In 2018, we transitioned to 100-percent employee-ownership. Nationally ranked as one of Forbes Best Midsize Employers in 2021 and 2022 and as one of the Best Places to Work by the Boston Globe, the Washington Post, the Hartford Business Journal, and MaineBiz, our culture draws raw talent from college interns to seasoned veterans with substantial years of experience in their field. We credit empowerment, innovation and “thinking great” for our continual growth and success. Most important, we are thankful for our employees and are proud to have one of the most exciting project portfolios in the business. Quality Control Manager Formulate and maintain quality control objectives, coordinating them with production procedures, ensuring product reliability and cost minimization. The Quality Control Manager will play an integral role during all phases of a project, beginning in pre-construction and ending with project close-out. During the pre-construction phase, the individual will review all contract quality language and coordinate constructability with the owner and architect(s). During the construction of a project, work with teams to track and measure quality data for performed work, coordinate quality efforts with subcontractors, and be a resource for any quality-related issues on-site. Additional responsibilities include conducting inspections and walkthroughs for close-out, setting and maintaining company policies relating to quality, and participating in business development activities, when applicable. Required Skills Pre-Construction Help with proposals, attend selected interviews Review selected supplemental instructions/specs for completeness Review contract quality language Constructability review on selected projects or pre-cons, coordinate with architect Set and maintain company policy The preparation of the companies QA manual control and supervision of all amendments and revisions Update policy as required Hold preconstruction meeting with team and develop site specific plan, include specifically who is doing each task Review and improve 100% material verification policy Manage Program as work progresses Insure testing log set up prior to start of work, help coordinate outside testing Attend pre-ops on selected projects: private projects, self-perform operations, finish sensitive projects Act as resource for specific quality related issues Help manage subcontractor quality efforts, develop methods to encourage subs to plan Help insure selected operations proceed according to plans and specifications Meet with client on selected projects to review quality expectations and concerns Review deficiency logs, monitor items completed on a timely basis Insure we are following material verification policy Measurement and communication Make sure paperwork gets done Audit paperwork. Rate paperwork Communicate results to teams Manage QIHTU, send out weekly message like tool box talks, post on intranet Review pre op minutes and post samples on intranet Recognize and communicate common deficient items including methods to avoid Close out/post close out Keep statistics on call backs Focus on call back issues - water and air infiltration, hvac Conduct pre-punch inspection on selected projects Perform warranty walk-throughs, compile statistics, distribute lessons learned Required Experience High School degree with applicable experience or Bachelor's Degree in Construction Management, Engineering, or related area of specialty required; 5-10 years' experience in the construction field or in a related area required; Thorough knowledge of the construction field's concepts, practices, and procedures required; An Affirmative Action / Equal Opportunity Employer Company 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.

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.