Quality manager jobs in Weymouth Town, MA - 543 jobs

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

Pay Rate: $40-$50/hr Work Model: Hybrid (Onsite Tuesday, Wednesday, Thursday) The Quality Systems Specialist, under the direction of the QS&C management team, supports global Quality Systems to ensure compliance, operational effectiveness, and fitness for intended use in alignment with applicable global SOPs. Key Areas of Accountability Quality System Governance & Support Assist in governance of Quality System applications, including harmonizing processes across sites Participate in meetings/workshops with Site Process Owners and business SMEs to gather requirements for system improvements and ongoing maintenance Join user forums to collect ongoing requirements, prioritize needs, and triage issues Follow up on requests, issues, and project activities; provide status updates to managers and working teams Change Control & Compliance Initiate and manage change controls through completion, including all required documentation Ensure systems remain in a validated state by supporting periodic user access reviews, change management, business administration, and deviations/CAPAs Support investigation, escalation, and resolution of system-related issues Validation & Documentation Support validation activities, including: Requirements gathering Validation planning Design qualification Authoring and executing test plans and test scripts Discrepancy management Preparing system descriptions and validation summary reports Maintain user-related documentation and ensure updates as new functionalities are introduced Cross-Functional & User Support Assist manager with communication between vendor/IT teams Provide customer support through system administration, training management, and onboarding of new users Generate metrics to support Quality Systems performance Support regular system updates/releases and provide assessments and recommendations on new features Academic & Technical Qualifications Bachelor's degree or higher in a relevant computer, technical, quality, or scientific discipline (multi‑disciplinary background preferred) 3-6 years of experience in a high‑volume commercial or clinical pharma/healthcare environment Proficiency in MS Word, Excel, and Quality System processes Experience with Veeva Vault Quality Docs, TrackWise, and ComplianceWire is a plus Strong understanding of US FDA and European regulatory requirements, GAMP, and phase‑appropriate compliance expectations Knowledge of Regulatory Compliance and ICH Guidelines General Comments Position Title: Quality Systems Specialist Pay Rate Range: $40-$50/hr

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

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

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

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.

The Quality Coordinator will work in the Internal Quality Team on military/ aerospace products. The position will be responsible for activities that effectively identify, manage and report status of products and compliance with applicable regulatory requirements in the Aerospace/Defense Industries. The Quality Coordinator will be assisting the quality team in retrieving all proper documentation needed before product goes to production. This position reports directly to the Quality Supervisor From time to time assist in stockroom with kitting/cut verification of cables Preform inspections of documents in the production area, being sure they are at the required revision levels and ensuring paperwork is filled out correctly and completely Assist the quality team with incoming inspections, documenting per procedure Requirements: This is an onsite position Knowledge and experience of various computer applications Detail oriented Must be a US person for US Department of Defense work Familiarity of AS9100 and ISO9000:2001 a plus Attention to detail and asking why is required Familiar with Military or Medical products/procedures a plus High School Diploma required Technical training in or knowledge of fiber optics a plus Fluency in English (verbal and written). PM19 PI7a35455e52b6-31181-39254872

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

Job Description Quality Control Manager (QCM), Federal Construction Columbus, GA Full-Time, Onsite, Federal Project Assignment About the Role We are seeking an experienced Quality Control Manager (QCM) to support federal government construction projects in the Columbus, GA area. This role is critical to ensuring all construction activities comply with contract documents, USACE standards, EM 385 requirements, and applicable federal regulations. The QCM will serve as the primary point of contact for quality-related matters and will work closely with the Project Manager, Superintendent, subcontractors, and government representatives. Key Responsibilities Develop, implement, and manage the Contractor Quality Control (CQC) Plan in accordance with USACE and DoD requirements Conduct and document the Three-Phase Control Process: Preparatory, Initial, and Follow-Up Inspections Review and manage submittals, RFIs, and quality documentation for compliance with contract specifications Perform daily quality control inspections across all phases of construction including civil, structural, architectural, and MEP work Prepare and submit daily QC reports, inspection logs, deficiency tracking, and corrective action documentation Coordinate and lead preparatory meetings, initial inspections, and quality coordination meetings Interface directly with Government QA personnel and participate in inspections, audits, and site walks Ensure work is executed in accordance with approved plans, specifications, and safety standards Track deficiencies, oversee corrective actions, and verify closeout compliance Support project closeout activities including punch lists, as-builts, and final inspections What We're Looking For Minimum 5 years of experience as a Quality Control Manager on federal construction projects Demonstrated experience working on USACE, NAVFAC, or other DoD projects Strong knowledge of federal construction standards, quality processes, and documentation requirements Experience coordinating with government inspectors and contracting officers Ability to manage multiple features of work and maintain organized quality records Strong communication skills and attention to detail Required Certifications & Qualifications USACE Construction Quality Management (CQM) for Contractors Certification OSHA 30-Hour Construction Safety Certification Working knowledge of EM 385-1-1 safety standards Ability to pass federal background requirements and site access credentials Valid driver's license Why Join Us? Work on stable, long-term federal government construction projects Clear scope, defined quality standards, and structured project environments Opportunity to work with experienced federal project teams Competitive compensation based on experience and certifications Total Rewards & Benefits Competitive salary or hourly compensation based on experience Per diem, lodging, and travel support if applicable Health insurance options and paid time off Consistent federal project pipeline Apply Today Qualified candidates are encouraged to apply to be considered for current and upcoming federal construction projects in the Columbus, GA area. Confidential inquiries are welcome.

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.

Methuen Construction is a leading self performing industrial and heavy civil general contractor with over 65 years of experience We specialize in the construction of water and wastewater treatment facilities industrial facilities and other critical infrastructure projects Serving private municipal state and federal clients across the Northeast we deliver innovative well planned projects that are completed on time and with an uncompromising focus on safety At Methuen we foster a culture of teamwork respect and a can do attitude that values every teammate and stakeholder The Quality Control Manager ensures our quality control program meets industry standards is audited evaluated and continuously improved This position reports to the Vice President and is responsible for the oversight of other teammates This is a full time salaried exempt position Your Role Responsible for a thorough understanding of project drawings and specifications to ensure compliance Review track and process submittals and RFIs ensuring timely resolution Review and plan construction means and methods with SuperintendentLead pre activity meetings with all project trades to ensure a thorough understanding of project requirements by all stakeholders prior to the start of any new definable feature of work Collaborate with Superintendent and project team to plan and sequence phases of work Complete daily quality control reports Coordinate schedule and document all required tests and inspections Monitor and inspect ongoing project work to ensure conformance to contract documents and applicable standards Generate distribute and track incomplete work lists punch lists and non conformance notices Prepare maintain and submit project closeout and record documents Mentor the development of junior engineers and provide feedback on performance Generate verbal and written communications required to meet administrative requirements of projects Monitor the planning for project safety application of safety rules regulations and programs Maintain a positive image of the company with vendors subcontractors clients and teammates Act as primary point of contact for client subcontractors vendors and MC project team for quality related issues Responsible for maintaining and updating projects Quality Control Program Ensure that program meets contractual requirements current industry standards and best practices Maintain access to applicable reference standards and facilitate access by project team Subject matter expert for quality control test and inspection protocols Generate and conduct training relative to QC processes and procedures Perform audits of project adherence to QC Program and project specific plans Record and report results Lead investigation into non conformances determine root cause recommend corrective actions publish non conformance bulletins Your Education and Experience Minimum 10 years combined experience within the construction industry as a Project Superintendent QC Manager Project Manager Project Engineer andor Construction Manager required Bachelors degree in civil engineering Mechanical Engineering or Construction Management preferred Experience with project management software ie Procore CMiC preferred Experience with US Army Corps of Engineers Construction Quality Management for Contractors preferred What You Bring to the Team Proven ability to excel in a fast paced environment Excellent written and verbal communication skills Ability to work independently and as part of team Outstanding attention to detail Strong interpersonal tact diplomacy influence motivation skills Ability to work with multiple project teams Ability to read and interpret contract language Work EnvironmentPhysical Demands Ability to lift 50 pounds Ability to stand for extended periods of time and safely maneuver around the nearby presence of various construction equipment and vehicles on an active construction site Prepared to regularly encounter moving mechanical parts high precarious places fumes or airborne particles and a variety of outside weather conditions Able to climb temporary or permanent stairs and ladders Able to bend squat kneel crawl crouch balance and stoop reach on a regular basis Specific vision abilities required by this job include close vision distance vision color vision peripheral vision depth perception and ability to adjust focus Travel Travel is limited and primarily local to jobsite locations in the Northeast Benefits Group health & welfare benefits including options for medical dental and vision Company Benefits Employee Life Insurance & Accidental Death & Dismemberment AD&D Spouse and Dependent Life & AD&D Short Term Disability STD Long Term Disability LTD Employee Assistance Program and Health Advocate Voluntary benefits at discounted group rates for accidents critical illness and hospital indemnity Flexible Time Off Program includes vacation and personal time Paid Sick and Safe Leave Paid Parental Leave Program 10 Paid Holidays 401k Plan company matching contributions up to 4 Employee Referral Program Equal Opportunity Employer including disabled and veterans Pay range 110000 120000 annually Please note that all positions require pre employment screening including drug and background check as a condition of employment Why Youll Love Working Here Methuen Construction is widely recognized as one of the most successful self performing general contractors in the industry Built on over 65 years of experience Methuen Construction employs the highest skilled trades professionals and managers As we expand our construction territory diversify our client base and enhance our operational capabilities our need for highly skilled teammates is growing We offer top tier compensation and benefits in addition to a team oriented motivated and respectful company culture LI HP1 LI Onsite

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.

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

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

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.

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 Role The Research Associate/Quality Engineer will be responsible for performing mechanical testing of materials and components using instruments such as Mecmesin, Instron, or equivalent force-measurement systems. This role will support tensile, compression, shear, puncture, and force displacement characterization to ensure product performance, robustness, and compliance with internal quality standards. In addition, the individual will contribute to method development, qualification activities, and routine QC release testing to support clinical and commercial manufacturing programs. This is a unique opportunity to be part of an emerging early-phase clinical company bringing innovative technology to the global market. Key Responsibilities Essential duties and responsibilities include the following. Other duties may be assigned. Perform mechanical testing of materials, components, and finished MAP products using Mecmesin, Instron, or comparable systems, including tensile, compression, shear, puncture, and force displacement profiling. Develop, optimize, and maintain mechanical test methods to support product characterization, comparability studies, and design verification/validation activities. Execute routine QC mechanical release testing aligned with cGMP expectations and data integrity standards. Troubleshoot mechanical testing issues, support instrumentation maintenance, and ensure proper calibration and documentation Analyze mechanical test data, prepare technical reports, and document all activities in audit-ready laboratory records. Collaborate cross-functionally with QC, Analytical Development, Process Development, Manufacturing, and Regulatory teams to enable program success. Assist in broader QC testing efforts as needed, including support for analytical, functional, and stability assays. Independently author method SOPs, analytical protocols, technical reports, and contribute to regulatory submissions. Maintain rigorous laboratory documentation and complete, audit-ready analytical records. Collaborate effectively with QC, Manufacturing, Process Development, and Regulatory teams to enable program success across phases. Thrive in a fast-paced, cross-functional environment with excellent communication and organizational skills. Qualifications Bachelor's degree in Mechanical Engineering, Materials Science, Biomedical Engineering, or a related discipline; 1-3 years of relevant mechanical testing or QC experience, or a master's degree with applicable laboratory experience. Hands-on experience with mechanical testing instruments such as Mecmesin, Instron, Texture Analyzer, or equivalent force-measurement systems. Demonstrated proficiency in tensile, compression, shear, puncture, and force-displacement mechanical characterization. Experience developing, optimizing, and/or qualifying mechanical test methods for materials, components, or finished products. Familiarity with GMP, GLP, or ISO 17025 laboratory environments and strong understanding of data integrity (ALCOA+). Ability to analyze mechanical test data, generate clear technical reports, and maintain accurate documentation. Experience supporting QC release testing, method qualification, method transfer, or equipment qualification is a plus. Strong organizational skills with the ability to manage multiple workflows and prioritize effectively in a fast-paced environment. Excellent verbal and written communication skills and comfort working within interdisciplinary teams. Commitment to collaborative work within interdisciplinary project teams. At Vaxess, we're bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to ****************** .