Quality manager jobs in Raynham, MA - 501 jobs

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

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess' patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world. The Quality System Specialist / Senior Quality System Specialist plays a key role in supporting and enhancing Vaxess Technologies' Quality Management System (QMS) to ensure compliance with applicable GMP/GLP standards. This position focuses on maintaining robust electronic quality systems, managing controlled documentation, and supporting the integration of new processes and applications. Key Responsibilities: Quality System and Computerized System Oversight Support quality oversight for computerized systems, including QMS implementation, configuration, validation, and data migration activities. Assist in launching new or enhanced system functionalities and communicating updates or user guidance to ensure effective adoption. Collaborate with internal stakeholders and system vendors to ensure integrated processes across modules (Document Control, Training, Equipment, and Material Management). Troubleshoot and resolve user issues as needed. Documentation and Record Management Manage the full lifecycle of controlled documents, including creation, revision, review, approval, distribution, and archival within the electronic document management system (EDMS). Ensure that controlled documents, such as SOPs, batch records, and specifications, are accurate, current, and compliant with regulatory and internal requirements. Coordinate document workflows with cross-functional teams to ensure timely completion and alignment with procedural requirements. Author or revise SOPs, forms, and work instructions supporting quality system and GMP operations. Training and Compliance Support Provide training and day-to-day support to employees on document control and system processes. Serve as a subject matter expert (SME) for document control and computerized systems during internal and external audits and inspections. Support tracking and reporting of quality metrics (e.g., training completion, document cycle time, CAPA effectiveness) to drive continual improvement. Qualifications: Bachelor's degree in Life Sciences, Engineering, or a related discipline preferred; equivalent work experience considered. 2-5 years of experience in a GMP, GLP, or GxP-regulated environment (pharmaceutical, biotechnology, or medical device industry). Experience with electronic quality management systems (e.g., Enzyme, Greenlight Guru, Veeva, MasterControl, etc.) is strongly preferred. Familiarity with relevant regulations and standards (21 CFR Parts 210/211/11/820; ISO 9001/13485). Excellent attention to detail, organization, and communication skills; ability to manage multiple priorities in a dynamic environment. Collaborative, proactive, and adaptable work style aligned with a fast-paced, innovation-driven company. Vaxess, a venture-backed life sciences company, is building a team of exceptional people to rapidly advance products on its microneedle array platform. We work closely as a team and thrive in a dynamic, exciting, and engaging work environment. If you're interested in joining the Vaxess team, please submit your CV/resume to ****************** .

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.

Cambridge, US; Gaithersburg, US; New Jersey, US | full time | Job ID: 9897 As Director, Clinical Quality Assurance Compliance you will lead quality assurance activities across clinical development programs in global teams. This role focuses on implementing a proactive, risk-based quality strategy, ensuring GCP compliance, fostering a culture of quality within the Global Development Organization whilst supporting delivery of our clinical trial portfolio. Responsibilities * Develop and implement a proactive, risk-based Clinical Quality Strategy for assigned high-priority trials or programs, ensuring inspection readiness and GCP compliance * Collaborate with internal teams, collaboration partners as well as external vendors (e.g. CROs) to identify, investigate, and remediate clinical trial risks and quality issues, including CAPAs and effectiveness checks * Actively contribute to Clinical Trial teams by providing quality guidance and reviewing key study documentation * Enable continuous inspection readiness and compliance with GCP, regulatory requirements, and internal standards * Lead or support inspection preparation, facilitation, and follow-up activities * Review and manage Quality Agreements with CROs and other vendors, ensuring compliance with agreed standards * Lead and develop a team, fostering transparency and proactive communication * Drive a culture of quality and continuous improvement across the Global Development Organization, including authoring and reviewing clinical quality procedures. * Acting as an ambassador for quality: ensuring that quality is an enabler of delivery. Qualifications Education * University degree in life sciences; advanced degree preferred Experience * Profound professional experience (beyond 10 years) in a GCP-regulated environment * Strong GCP expertise gained in a senior Quality Management and / or Clinical Operations role. * Strategic and Risk-based mindset with experience developing quality strategies at program level * Solid understanding of global clinical regulations and guidelines (ICH, FDA, EMA, MHRA) * Experience in team leadership and development (in the GCP environment preferred) * Experience in managing, hosting or supporting regulatory authority inspections (EMA/FDA/MHRA) * Proficiency in MS Office and electronic quality management systems * Fluent in English (Mandarin is a plus) Expected Pay Range: $202000/year to $247000/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). *Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities. Your Benefits: BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to: * Medical, Dental and Vision Insurance * Life, AD&D, Critical Illness Insurance * Pre-tax HSA & FSA, DCRA Spending Accounts * Employee Assistance & Concierge Program (EAP) available 24/7 * Parental and Childbirth Leave & Family Planning Assistance * Sitterstream: Virtual Tutoring & Childcare Membership * Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown. * 401(K) Plan with Company Match * Tuition Reimbursement & Student Loan Assistance Programs * Wellbeing Incentive Platforms & Incentives * Professional Development Programs * Commuting Allowance and subsidized parking * Discounted Home, Auto & Pet Insurance …and more! More details to be shared. Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world. As part of the Greater Boston area, the city is often referred to as the "biotech supercluster" due to its high concentration of life sciences firms. This unique ecosystem is the result of a model partnership between academia and industry, fostering collaboration and innovation and driving the development of new therapies, medical devices, and diagnostics. As Cambridge's thriving life sciences industry continues to evolve, the city remains a beacon of knowledge, innovation, and collaboration, poised to shape the future of science and technology. Apply now - We look forward to your application! Apply for our Cambridge, US; Gaithersburg, US; New Jersey, US location and simply send us your documents using our online form. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider 'HireRight'. You will be informed accordingly by your BioNTech-Recruiter. Inspired? Become part of #TeamBioNTech. BioNTech, the story At BioNTech, we are more than just a biotechnology company - we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases. Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine. Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world. BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you! BioNTech - As unique as you ****************

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more ************************* and follow us on X, LinkedIn and Facebook. Role Summary: The Director, Clinical Quality Assurance leads GCP compliance and quality oversight for clinical programs and commercial products. This role is responsible for developing and implementing risk-based strategies; managing audits, inspections, and vendor oversight; and ensuring global regulatory compliance. This role partners cross-functionally to drive continuous improvement, inspection readiness, and sponsor oversight, while proactively identifying and mitigating quality risks. As a subject matter expert, this role establishes program support to uphold industry best practices and regulatory requirements. This role is based in Waltham, MA. Primary Responsibilities Include: * Inform and contribute to audit planning and strategy * Perform and/or coordinate clinical site and vendor audits * Oversee deviations, quality issues (QIs), CAPAs, effectiveness checks, root cause analyses, and associated KPIs * Advise internal stakeholders and external partners on GCP compliance matters and identify emerging non-compliance trends * Support inspection readiness activities and co-host regulatory inspections * Develop and deliver GCP-related training; contribute to the creation, revision, and maintenance of policies, SOPs, and work instructions in alignment with global regulatory requirements * Conduct and/or manage the qualification and oversight of service providers * Ensure service providers adhere to quality programs and applicable regulations, maintaining inspection readiness * Assess and escalate compliance risks identified through audits to protect subject safety, data integrity, and business continuity * Lead or support the preparation for and response to regulatory audits and inspections, ensuring adherence to requirements and timely resolution of findings * Support investigational new drug (IND) applications and related correspondence with global regulatory authorities Education and Skills Requirements: * Bachelor's degree in a scientific, allied health, or medical field required; Master's degree preferred * Minimum of 10 years of progressive experience in the pharmaceutical or biotechnology industry, including at least 5 years in a Clinical Quality Assurance role (or an equivalent combination of PV and QA experience) * Deep knowledge of global regulations (e.g., FDA, EMA) and guidelines (e.g., ICH, GVP, GxP), including safety reporting requirements * Broad clinical development experience across all phases (Phase I through BLA/NDA) * Strong understanding of GCP quality principles spanning preclinical, clinical, and commercial stages * Proven experience developing and implementing risk-based clinical quality assurance programs * Demonstrated success leading clinical site and supplier audits, managing regulatory inspections, and responding to findings * Skilled at effectively communicating quality events and outcomes to internal stakeholders * Excellent interpersonal, verbal, and written communication skills * Working knowledge of multiple therapeutic areas is a plus * Results-oriented, with the ability to set clear objectives, manage competing priorities, and meet dynamic timelines * Flexible and creative problem solver with a proactive mindset * Highly collaborative team player who fosters open communication and cross-functional cooperation * Willingness to travel up to 20% based on business needs #LI-Onsite MA Pay Range $190,000-$232,800 USD The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

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

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

Are you a current UMass Memorial Health caregiver? Apply now through Workday. Exemption Status: Non-Exempt Hiring Range: $29.35 - $39.53 Please note that the final offer may vary within this range based on a candidate's experience, skills, qualifications, and internal equity considerations. Schedule Details: Monday through Friday, Weekends (Saturday and Sunday) Scheduled Hours: 7a-7p 7p-7a Shift: 4 - Mixed Shift, 12 Hours (United States of America) Hours: 40 Cost Center: 10020 - 2366 Emergency Med Svcs Union: NAGE (National Association of Government Employees) This position may have a signing bonus available a member of the Recruitment Team will confirm eligibility during the interview process. Everyone Is a Caregiver At UMass Memorial Health, everyone is a caregiver - regardless of their title or responsibilities. Exceptional patient care, academic excellence and leading-edge research make UMass Memorial the premier health system of Central Massachusetts, and a place where we can help you build the career you deserve. We are more than 20,000 employees, working together as one health system in a relentless pursuit of healing for our patients, community and each other. And everyone, in their own unique way, plays an important part, every day. Personnel who have competency in airway management, including Medication Assisted Intubation/Rapid Sequence Intubation (MAI/RSI) as well as experience managing episodes of acute clinical decompensation in medically ill patients serve in the North Pavilion (PAV) in capacities consistent with their level or training and scope of practice. All work performed in the hospital will be done under the clinical supervision of the attending physician. Major Responsibilities: 1. Working in a collaborative fashion as part of the care team with physicians, APPs, PCAs, Unit Secretaries, Respiratory Therapists, and RN staff. 2. When summoned in case of critical decompensation or cardiac arrest, at the direction of the physician or APP, will be responsible for management of the patient's airway according to the Resuscitation and Airway Management Specialist (RAMS) training and scope. The airway procedures will include: o Use of LMAs and other supraglottic airways. o BVM ventilation. o Use of PEEP valve during ventilation. o Direct laryngoscopy. o Video laryngoscopy. o Orotracheal and nasotracheal intubation. o Use of bougie to assist in intubation. o Cricothyrotmy in Cannot intubate, cannot ventilate (CICO) situations. o Placement of orogastric or nasograstric tube. 3. Participate in a program of patient monitoring (known as “Overwatch”) with the following general characteristics: o Meeting with other clinical staff to identify patients at elevated risk of clinical decompensation and monitoring these patients for any acute changes throughout the course of a shift. o Responding and interfacing with the interdisciplinary team to help identify management strategies for patients identified in the above activities o Participate in clinical rounds in coordination with the interdisciplinary care team to review patients' condition and evaluate clinical progress. 4. Establish and maintain peripheral IV access when called upon by the clinical team in cases of patients with difficult IV access. 5. Assisting with transport of critical patients to and from areas of the hospital while monitoring for any acute changes. 6. Performing phlebotomy when needed urgently for “STAT” blood draws or in the case of actuely decompensating patients. 7. Responds according to hospital policies to Visitor/Employee/Outpatient (VEO) emergencies as needed All responsibilities are essential job functions. Standard Staffing Level Responsibilities: 1. Complies with established departmental policies, procedures, and objectives. 2. Attends variety of meetings, conferences, seminars as required or directed. 3. Demonstrates use of Quality Improvement in daily operations. 4. Complies with all health and safety regulations and requirements. 5. Respects diverse views and approaches, demonstrates Standards of Respect, and contributes to creating and maintaining an environment of professionalism, tolerance, civility and acceptance toward all employees, patients, and visitors. 6. Maintains, regular, reliable, and predictable attendance. 7. Performs other similar and related duties as required or directed. II. Position Qualifications: License/Certification/Education: Required: 1. Certified in CPR - Basic Rescue by either the American Red Cross or the American Heart Association. 2. Certified in Advanced Cardiac Life Support by the American Heart Association. Experience/Skills: Required: 1. At least three years of experience in the care of patients with critical illness within the last 5 years. 2. Experience with Rapid Sequence Intubation with at least 20 intubations performed. 3. Experience with surgical cricothyrotomy. 4. Experience with placement of nasogastric tubes. 5. Experience with placement of peripheral IVs. 6. Experience and training on placement of Intraosseos access device. 7. Demonstrated ability to work well under often stressful situations. 8. Strong organizational and interpersonal skills. 9. Effective oral and written communication skills. Preferred: 1. Minimum three years of experience in an urban EMS service integrated with a municipal first response system. 2. Pediatric Advanced Life Support (PALS) certification. Unless certification, licensure or registration is required, an equivalent combination of education and experience which provides proficiency in the areas of responsibility listed in this description may be substituted for the above requirements. Department-specific competencies and their measurements will be developed and maintained in the individual departments. The competencies will be maintained and attached to the departmental job description. Responsible managers will review competencies with position incumbents. III. Physical Demands and Environmental Conditions: Work is considered medium. Position requires work indoors in a patient care environment. Constantly: Working Indoors. Frequently: Sitting, Standing, Walking, Pushing, Pulling, Twisting, Reaching, Performing Repetitive Movements, Precise Motor Skills required, Precise Hearing required, Precise Vision required; Lifting, Carrying, Pushing, and Pulling - Less than 10 pounds to 20 pounds. Often: Balancing, Bending, Kneeling, Grasping, High Level of Stress; Lifting, Carrying, Pushing, and Pulling - 20 pounds to over 100 pounds. Never: Climbing, Kneeling, Working Outdoors, Working in Temperature Extremes, Working at Heights. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. We're striving to make respect a part of everything we do at UMass Memorial Health - for our patients, our community and each other. Our six Standards of Respect are: Acknowledge, Listen, Communicate, Be Responsive, Be a Team Player and Be Kind. If you share these Standards of Respect, we hope you will join our team and help us make respect our standard for everyone, every day. As an equal opportunity and affirmative action employer, UMass Memorial Health recognizes the power of a diverse community and encourages applications from individuals with varied experiences, perspectives and backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, gender identity and expression, protected veteran status or other status protected by law. If you are unable to submit an application because of incompatible assistive technology or a disability, please contact us at ***********************************. We will make every effort to respond to your request for disability assistance as soon as possible.

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

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

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.

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.

ABOUT THE ORGANIZATION: Edesia is a non-profit social enterprise on a mission to end global malnutrition. We manufacture and distribute life-saving, ready-to-use therapeutic foods-such as Plumpy'Nut and Nutributter-to treat and prevent malnutrition among children and mothers in the world's most vulnerable and hard-to-reach communities. Through strong partnerships with leading humanitarian organizations, NGOs, and Ministries of Health, we ensure our products reach those who need them most-even in the midst of the most complex and challenging humanitarian emergencies. JOB SUMMARY: The Quality Supplier Manager is responsible for ensuring that all domestic and international suppliers meet Edesia's high standards for food safety, quality, and compliance. This role will oversee supplier approval, verification, and monitoring programs to ensure consistency with regulatory requirements, industry standards, and Edesia's internal quality management systems. The individual will be instrumental in driving continuous improvement, strengthening supplier partnerships, and ensuring the integrity of Edesia's supply chain. In addition, this role will serve as the primary point of contact during customer and certification audits, supporting preparation, documentation, and responses to demonstrate compliance and supplier program effectiveness. RESPONSIBILITIES AND DUTIES: Supplier Management & Approval Lead the supplier approval process for both domestic and foreign suppliers, including documentation review, risk assessment, and compliance checks. Manage and maintain Edesia's Approved Supplier List (ASL), ensuring timely updates and compliance with regulatory and customer requirements. Develop, distribute, and evaluate supplier questionnaires, scorecards, and risk-based assessments. Work closely with the Quality Director and Senior Director to address supplier-related issues, out-of-specification batches, and recurring or emerging quality trends. Collaborate on root cause analyses, escalation of critical supplier problems, and development of strategic actions to improve supplier reliability and performance. Supplier Audits & Verification Manage the Supplier Assurance Program for (domestic and foreign) ensuring compliance with Edesia's standards, GFSI schemes, and applicable regulations. Verify and validate the audit schedule based on risk, organizing supplier visits, and ensuring that audit reports are reviewed and filed appropriately. Additionally, ensure that corrective and preventive actions are obtained from suppliers following the visits. Manage the Foreign Supplier Verification Program (FSVP) in compliance with FDA and FSMA requirements. Partner with cross-functional teams to evaluate supplier performance and implement corrective/preventive actions (CAPAs) when needed. Documentation & Compliance Review and maintain supplier documentation, including food safety certifications, specifications, questionaries, etc. Ensure all foreign suppliers maintain compliance with U.S. import regulations and certifications. Maintain audit records, risk assessments, and supplier documentation in alignment with regulatory and certification requirements (e.g., BRCGS, FDA, and customer requirements). Performance Monitoring & KPIs Develop and maintain supplier performance scorecards, monitoring key performance indicators such as quality, service, compliance, and cost. Identify trends in supplier performance data and work with suppliers to implement improvements. Provide regular reports on leadership on supplier performance and risk. Leadership and Continuous Improvement Directly oversee the Quality Assurance Technician fostering their development and ensuring alignment with quality standards. Review and approve the QA technician's material sampling for product release, ensuring compliance with quality standards and specifications. Collaborate with Procurement, Quality, and R&D teams to evaluate new and existing suppliers for innovation, efficiency, and risk mitigation. Recommend and implement improvements to Edesia's supplier management systems and processes. Support production and quality teams in troubleshooting raw material quality issues and minimizing supply disruptions. QUALIFICATIONS: B.S. in Nutrition or Food Science-related field. Minimum 5 years of experience in supplier quality management, quality assurance, or procurement within food manufacturing or a regulated industry. Must have knowledge and experience with food safety regulations such as HACCP, GFSI Standards, Codex, GMP's, SSOP programs and US food regulations. Must have experience interacting with regulatory agencies and customer inspections. Able to work effectively and efficiently in cross functional team environments. Strong communication skills and ability to interact with all levels throughout the organization. Highly innovative and creative. Excellent organization/time management and problem-solving skills. Strong customer focus and ability to prioritize and adapt to compliance and business needs required. Strong computer skills (proficient with Power Point, Excel and Word) and familiar with SAP. WORK CONDITIONS: General office environment, plus time spent in Quality lab and production area. Occasional lifting, bending, pulling, some of which could be heavy (>15 lbs) or require the use of carts. High utilization of office equipment, phone, computer, etc. Ability to travel up to 50% of the time, both domestically and internationally, to conduct supplier visits, audits, and inspections. Must be able to travel to vendors/partners as well as domestic and international conferences and meetings related to quality. HOURS: 8:00 am to 4:30 pm (may be required to work other shifts/hours, as needed to support projects) The requirements described are representative of those that must be met to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Site: Mass General Brigham Health Plan Holding Company, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary Responsible for overseeing and improving clinical performance metrics and ensuring compliance with healthcare regulations and accreditation standards. Collaborates with clinical teams to develop strategies for improving patient care outcomes and ensures that clinical operations align with regulatory and quality requirements. Essential Functions -Monitor and analyze clinical performance data to identify areas for improvement in patient care and outcomes. -Ensure compliance with all regulatory, accreditation, and quality standards across clinical operations. -Collaborate with clinical staff to implement performance improvement initiatives and ensure best practices in patient care. -Develop and maintain clinical performance dashboards and reports to track key metrics. -Coordinate with quality, compliance, and risk management teams to ensure alignment with organizational goals. -Provide training and education to clinical teams on performance improvement, regulatory compliance, and accreditation standards. -Conduct audits and assessments of clinical processes to ensure continuous quality improvement. -Work with leadership to set performance goals and develop action plans to achieve them. Qualifications Education Bachelor's Degree required; work experience can be substituted in lieu of a degree License/Certification Massachusetts Registered Nurse (RN) license highly preferred Experience At least 3-5 years of experience in clinical performance management, compliance, or quality improvement required Knowledge, Skills, and Abilities Knowledge of healthcare regulations, accreditation standards (e.g., Joint Commission), and clinical performance metrics. Strong analytical skills with the ability to interpret clinical data and identify improvement opportunities. Excellent communication and collaboration skills to work effectively with clinical teams and leadership. Detail-oriented with a strong understanding of healthcare regulations and accreditation standards. Proficiency in performance management software and tools for tracking clinical outcomes. Ability to lead performance improvement projects and implement evidence-based practices. Additional Job Details (if applicable) Working Conditions This is a remote role that can be done from most US states Remote Type Remote Work Location 399 Revolution Drive Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $78,000.00 - $113,453.60/Annual Grade 7 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: Mass General Brigham Health Plan Holding Company, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

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

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.

Director, Quality Control (QC) An innovative biotechnology company developing next-generation biologics and engineered fusion protein therapeutics focused on immune and autoimmune-driven diseases is seeking a Director of Quality Control. As multiple programs progress through IND-enabling studies and early clinical development, this leader will build and scale the QC function, ensure analytical excellence, and drive phase-appropriate GMP compliance across a growing modality portfolio. Key Responsibilities: QC Strategy & Leadership: Build and lead a high-performing QC organization supporting a biologics and engineered fusion protein pipeline. Develop QC strategy aligned with IND-enablement, early-phase manufacturing, tech transfer, and later-stage readiness. Grow, mentor, and manage QC staff across analytical, microbiology, and sample management groups. Establish scalable QC systems and processes that evolve with increasing program complexity. Analytical & Method Lifecycle Ownership: Oversee analytical testing for biologics and fusion proteins including potency, purity, structural characterization, binding assays, and cell-based functional assays. Lead method development, qualification, transfer, and validation at internal labs and CDMOs while ensuring compliance with ICH Q2(R2), ICH Q6B, USP, and biologics-specific guidance. Ensure robust specification setting, comparability strategy, and control strategy alignment as programs advance. QC Operations & Laboratory Management: Direct release and stability testing for drug substance, drug product, intermediates, and raw materials under global GMP standards. Oversee QC laboratory capabilities, instrumentation strategy (HPLC/UPLC, CE, MS, ELISA, qPCR, cell-based platforms), and LIMS and data integrity systems. Ensure efficient sample management, chain of custody, and accurate phase-appropriate documentation. Quality Systems & Regulatory Readiness: Lead QC investigations, OOS and OOT assessments, deviations, CAPAs, change controls, and stability commitments. Support regulatory submissions including INDs, IMPDs, and BLAs through authoring and review of analytical and QC sections. Represent QC in regulatory inspections and ensure readiness aligned with FDA, EMA, and ICH expectations for biologics and advanced modalities. Cross-Functional Collaboration: Partner with CMC, Process Development, MSAT, Regulatory, and External Manufacturing teams to support analytical control strategies. Provide QC input for product lifecycle planning, risk assessments, fusion protein engineering updates, and comparability justifications. Manage QC activities at CDMOs and external labs including vendor qualification and ongoing performance monitoring. Qualifications MS or PhD in Biochemistry, Molecular Biology, Immunology, Analytical Chemistry, or a related field. 10 to 15 years of QC experience in biologics or advanced modalities with at least 5 years in leadership roles. Expertise in analytical technologies for recombinant biologics and engineered fusion proteins. Experience supporting IND-enabling work, clinical material release, and method lifecycle management with CDMOs. Strong understanding of global GMP, ICH Q2(R2), Q5E, Q6B, and biologics regulatory frameworks. Proven capability in building QC teams, shaping lab infrastructure, and driving continuous improvement. Excellent leadership, communication, and cross-functional collaboration skills.