Quality manager jobs in New Bedford, MA

Our client is seeking a POS Quality Engineer to join their team! This position is located in Canton, Massachusetts. Execute functional testing for the client's POS systems in a lab environment Validate new POS features, patches, upgrades, and configuration changes Troubleshoot issues across POS hardware, networking, integrations, and payment systems Review logs, identify root causes, and escalate defects to internal teams and vendors Collaborate with vendors delivering POS products to ensure quality and readiness Support daily version testing, weekly releases, and continuous enhancements Maintain test cases, regression suites, and documentation Ramp up on the clients POS systems, environments, and workflows Execute manual testing independently and efficiently Understand integration points with kiosk, mobile apps, loyalty, and payments Build relationships with product, engineering, and vendor teams Contribute to expanding and maintaining POS test automation frameworks Improve test coverage, defect identification, and issue resolution speed Work independently with minimal oversight while communicating affectively Support performance-related testing for high-volume transaction scenarios Help streamline testing workflows to support frequent deployments Desired Skills/Experience: 5+ years of POS Quality Engineering experience Hands-on experience with any POS system such as: Aloha, Toast, NCR, Oracle Symphony, or other enterprise/custom POS systems Experience with payment systems such as: VeriFone, kiosk integrations, loyalty platforms, mobile ordering, and web integrations Strong manual testing proficiency with the ability to execute tests quickly and accurately Ability to troubleshoot logs, hardware, and light networking issues Experience collaborating with third-party vendors on POS deliverables Familiarity with automation frameworks and ability to contribute to automation improvements Prior experience working in a POS lab environment (devices, staging stores, simulators) Strong communication, organization, and self-management skills Benefits: Medical, Dental, & Vision Insurance Plans Employee-Owned Profit Sharing (ESOP) 401K offered The approximate pay range for this position is between $55.00 and $65.00. Please note that the pay range provided is a good faith estimate. Final compensation may vary based on factors including but not limited to background, knowledge, skills, and location. We comply with local wage minimums.

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

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

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.

OFFICIAL TITLE: School-based Manager of Educator Quality WORKING TITLE: School Manager of Educator Quality MONTHS: 12 SUMMARY DESCRIPTION OF CLASSIFICATION: School-based Manager of Educator Quality reports to the school's Principal and is a key member of the Instructional Leadership Team. The Manager of Educator Quality (MEQ) is responsible for the management and development of teachers, and the improvement of instructional practices of educators. The MEQ plans professional development both inside and outside of the classroom in conjunction with the team and takes responsibility for the academic programming alongside of the Principal. MINIMUM QUALIFICATION STANDARDS KNOWLEDGE, SKILLS, AND ABILITIES: Thorough knowledge of current educational principles, best practices and procedures in development and implementation of ELA curriculum, instruction, and assessment K-12. Knowledge of local, state and national standards and assessments and ability to support their application, development and implementation. Knowledge of district goalsto provide support through school visits, data analysis, and collaboration with other NBPS offices. Ability to effectively collaborate with staff, parents, and state and national colleagues to implement and monitor the strategic plan. Qualifications: * An understanding of the leadership necessary to accelerate the work for school improvement; * Knowledge of how to obtain academic results through the use of various data points; * An ability to plan and manage processes that lead to achieving tangible goals * An ability to lead in a fast-paced environment and the capacity to navigate challenging situations and time constraints. * Excellent interpersonal and communication skills, including strong public speaking skills; EDUCATION, TRAINING, AND EXPERIENCE: Master's degree required from an accredited college or university. Course work in educational leadership or administration.; A valid Massachusetts Administrator License; Principal/Assistant Principal preferred. Minimum seven years combined experience as a classroom teacher and/or successful recent leadership experience in assessing program needs, instructional planning, assessment development, and professional development. DUTIES AND RESPONSIBILITIES Curriculum: * Participate in the development and evaluation of new curriculum. * Identify and lead a team of administrators and teachers who will assist in curriculum development. * Conduct research and collaborate with faculty and staff in the design and development of new curriculum. * Coordinate the review/assessment of current curriculum to ensure that course/program is meeting intended grade level curriculum standards. * Use evaluations and data to make recommendations for how to improve and edit curricula on an annual basis through the creation of a curriculum revision cycle. * Develop a five year plan of curriculum development including the replacement of outdated materials. Assessment: * Manage implementation and administration of all state, district, and school common assessments. * Facilitate weekly data meetings to analyze student work, review information regarding classroom assessments, and plan for instruction; * Collect and disseminate best practices, external resources in the areas of benchmark and unit assessment data. * Work with school and district leadership to identify key metrics to monitor district, school and student progress to allow for informed decision making. * Develop, manage and report on staff, student and community surveys. Analysis and Reporting: * Provide timely and clear reports on data analyzed. * Manage data dashboards and other regular reports or analysis that answer questions for key stakeholders, provide insight on student, school performance trends and patterns; and informs discussions and strategic decisions at the district and school levels, (e.g. aggregate and subgroup trends). * Create a "public package" of achievement and other student-level data and provide a clear understanding of what the data means to critical audiences (School Committee, families and community, foundations, etc.) Coaching and Development: * Oversee the growth and development of teachers that will result in changed practices and ongoing progress monitoring system that can point to accelerated improvement for all students * Develop and support a culture of reflective practice among teachers; * Plan and support facilitation of professional development; * Conduct regular formal and informal teacher observations; * Conduct regular coaching cycles with teachers; * Provide formal and informal growth-producing feedback on observations, lesson plan review, and more; * Develop resources and plans to support teachers' professional growth; * Evaluate teachers using the Massachusetts Educator Evaluation system; * Collaborate with principal to conduct significant professional development around new initiatives in the areas of curriculum, data management and analytics. * Conduct all duties as assigned by the Principal * Other duties as assigned by the Superintendent and Deputy Superintendent TERMS OF EMPLOYMENT: * CERTIFICATE AND LICENSE REQUIREMENTS: Meet appropriate DESE Administrator requirements, or ability to do so * PHYSICAL DEMANDS (Special requirements such as lifting heavy objects and frequent climbing): NONE * SPECIAL REQUIREMENTS (Frequent overtime or night work required, etc.): Some extended day work required. Occasional attendance at evening meetings (i.e., School Committee, PTA, and community). * OVERTIME ELIGIBLE: NO * Salary Range;$100,000- $105,000 negotiated based on experience This description may change at any time

Employment Type: Full-Time FSLA: Salary/Exempt Division: Field Operations Department: Quality Reports to: Regional Quality Manager Supervisory Duties: No The Quality Manager (QM) will collaborate with several project teams throughout the lifecycle of their assigned projects. Their main responsibility is to support and be a technical and field resource for project teams. This dynamic role includes direct correspondence with the project teams, client/owner, manufacturers, design partners, and other stakeholders while working closely with trade partners to establish quality expectations and ensure execution of site-specific quality management plan (SSQMP). Responsibilities / Essential Functions Serves multiple projects with varying degrees of support based upon the site-specific needs, which may include: * SSQMP: Work with project teams to review and finalize their site-specific quality management plan. * Lessons Learned: Facilitate lessons learned process with assigned project teams. Provide guidance regarding lessons learned review and application during development of SSQMP and preoperational meetings. * Training: Provide training for project teams and subcontractors on quality initiatives, processes, and software/tool utilization (Procore/Templates/Guides). * Field Checks: Review of project documents and specifications to aid in development and execution of field checklist, conduct field walks and review of on-going work, support building plans for tracking and resolving deficiencies (including third party, owner/architect/engineer, and internal items). * Constructability: Participate in constructability review process as directed. * Mock-Ups/Initial Installs: Work with project teams to develop tracking and documentation of both mock-ups and initial installations. Help to identify high-risk and repeatable scopes/assemblies, review installation instructions and requirements, and help plan a successful installation to be used as a quality guidepost for the work. * Quality Pre-Operational Meetings: Track and support teams in the development of Quality Pre-Operational Meetings (agendas, document review and compilation, coordination with subject matter experts, etc.). Participate in meetings for high-risk scopes, or as otherwise directed. * Material Verification: Assist with the review and verification of incoming materials prior to use on site. * Punch List / Turnover: Work with the team to develop a mutually understood plan, inclusive of all stakeholders, for Punch List, Closeout, and Turnover. Support both the documentation and field efforts to successfully resolve outstanding issues. Additional Responsibilities include: * Subject Matter Expertise (SME): Based upon the background and specialty education of the candidate: participate in the development of scope-specific templates and quality plans, participate in meetings and working sessions related to their expertise, assist with the review in-field of specialty items as directed. * Corporate Quality Initiatives / Process Improvement: Actively note feedback and lessons learned and identify items that could help improve processes and reduce rework. Participate in working sessions, cross-departmental meetings, presentations, etc. as directed to help implement positive change. * Contracts and Specifications: Review contracts and specifications for quality related language to help project teams understand requirements. Key Skills * Strong communication skills. * Relies on extensive experience and judgment to plan and accomplish goals. * Understanding of the Three Phases of Control. * Ability to effectively manage diverse groups and teams, including outside testing agencies or subject matter experts/specialists. * Strong initiative and problem-solving abilities. * Ability to multi-task and self-prioritize. * Motivated and driven. * Ability to work in a team environment with a primary focus on collaboration. Required Experience * Requires a bachelor's degree in engineering, architecture, construction management, engineering technology, building construction, building science or related field. * 7-10 years as a Superintendent, Quality Control manager, Project Manager, Project Engineer, Construction Manager, Architect, Consulting Engineer, Quality Inspector or similar. * OSHA-30 certification. * Construction Quality Management for Contractors (CQM-C) Certification. * Must be familiar with the requirements of EM 385-1-1 and have experience in the areas of hazard identification, safety compliance and sustainability. * Experience leading and directing the work of others.

Join our award-winning client as Quality Manager and be the architect of exceptional customer service. Collaborate with internal partners to identify and address quality gaps, training needs, and performance issues, propelling continuous improvement. Key Responsibilities: Lead the charge: Guide manufacturing and inspection personnel in upholding quality systems. Sharpen processes: Develop, implement, and monitor policies for customer, internal, and supplier quality goals. Expert negotiator: Participate in technical discussions, represent the company, and resolve quality claims. Audit champion: Conduct audits to ensure materials, products, processes, and systems meet stringent specifications. Continuous improvement: Drive initiatives to reduce non-conformance and associated costs. Customer focus: Handle return authorizations, manage returned material, and address regulatory compliance requests. Problem solver: Lead problem-solving activities for internal and external concerns. Lab leader: Oversee and manage the on-site laboratory, including employee appraisals. Qualifications: Bachelor's in business or engineering (or equivalent work experience). 3+ years of Quality Management experience in manufacturing. Fabric medical device or textile materials knowledge a plus. ISO 9001 mastery and familiarity with ISO 13485. Certified Auditor or willingness to become one. Microsoft Office Suite proficiency and MRP system understanding. Strong time management skills to prioritize and deliver.

Job Details Bournewood Hospital - Brookline, MA Full Time Bachelors Degree $115000.00 - $125000.00 Salary Regular 8:00 am to 5:00 pm QA - Quality ControlDescription The Quality Assurance and Compliance Director is responsible for developing, implementing, and maintaining the hospital's Quality Assessment and Performance Improvement (QAPI) and Compliance Programs. This position ensures the hospital meets and exceeds standards established by regulatory and accreditation agencies, including The Joint Commission (TJC), the Massachusetts Department of Mental Health (DMH), the Bureau of Substance Addiction Services (BSAS), and the Centers for Medicare & Medicaid Services (CMS). This role works collaboratively with the Chief Nursing Officer, Director of Facility Operations, CEO, and other department leaders to coordinate data-driven quality assurance activities, regulatory compliance functions, and survey preparedness. The position promotes continuous regulatory readiness, supports the hospital's Quality Improvement (QI) Plan, manages incident reporting and patient safety initiatives, and provides education and consultation to staff and leadership regarding compliance and risk standards. The Director provides leadership, coordination, and oversight of all quality and compliance activities, supporting the organization's mission to provide safe, effective, and patient-centered behavioral healthcare. Essential Duties and Responsibilities Program Development & Oversight Develop, implement, and manage the hospital's QAPI and Compliance Programs in alignment with regulatory and accreditation standards. Ensure the integration of quality and compliance activities into all levels of the organization. Ensure risk management, patient safety, and compliance data are integrated into QI reporting. Maintain documentation for accreditation readiness (Joint Commission, CMS, BSAS, DMH), including Measures of Success, FMEAs, and audit tools. Coordinate and lead Quality and Compliance Committees, and co-lead Patient Safety Committee. May co-lead other committees as assigned. Regulatory & Accreditation Compliance Ensure ongoing readiness for TJC, DMH, BSAS, and CMS surveys and inspections. Serve as primary liaison during all regulatory surveys, audits, and inspections. Monitor changes in laws, regulations, and standards, and update hospital policies and practices accordingly. Performance Measurement & Reporting Collect, analyze, and report data related to clinical outcomes, patient safety, and performance indicators. Conduct root cause analyses, identify trends, and facilitate corrective action planning. Provide regular quality and compliance reports to hospital leadership and the Governing Body. Education & Training Develop and deliver staff education on quality improvement, patient safety, and compliance standards. Support department leaders in understanding and applying regulatory and accreditation requirements. Risk Management & Incident Oversight Oversee the hospital's incident reporting, investigation, and follow-up processes. Ensure timely reporting to regulatory agencies when required. Collaborate with leadership on risk reduction strategies. Policy Development & Review Maintain and review hospital policies and procedures for regulatory alignment. Ensure timely policy updates and staff notification. Communication Demonstrates professionalism, clarity, and respect in all forms of communication. Communicate effectively with staff, leadership, patients, and regulatory agencies. Maintains open, collaborative communication across departments to support transparency and teamwork. Demonstrates appropriate communication and composure in challenging or high-pressure situations, including when addressing compliance findings, staff concerns, or regulatory interactions. Provides constructive feedback and education to staff in a supportive and solution-focused manner. Ensures communication of quality and compliance data is accurate, timely, and easily understood by diverse audiences. Key Performance Indicators (KPIs) 100% of required regulatory reports submitted within mandated timelines. 100% of policies reviewed and updated per scheduled cycle. No Condition-level findings during regulatory surveys. 90% of incident reports investigated and closed within set timeframe. Evidence of ongoing performance improvement initiatives documented in QAPI reports. Compliance Responsibility Adheres to all hospital policies and procedures. Ensures compliance with all applicable standards, including TJC, DMH, BSAS, and CMS. Maintains confidentiality in accordance with HIPAA and hospital standards. Reports any suspected violations of compliance or safety standards immediately. May act as Privacy Officer and assist in HRO complaint resolutions. Competencies Knowledge of behavioral health care delivery systems. Commitment to ethical practice and patient rights. Ability to work collaboratively across interdisciplinary teams. Strong problem-solving, decision-making, and leadership skills. Capacity to manage confidential information with discretion. Qualifications Licensure: Current Massachusetts licensure as a Registered Nurse (RN), Licensed Practical Nurse (LPN), or Licensed Independent Clinical Social Worker (LICSW) required. Education: Bachelor's degree in Nursing, Social Work, Health Care Administration, or related field required; Master's degree preferred. Experience: Minimum of three (3) years of progressive experience in quality management, regulatory compliance, or performance improvement in a healthcare setting. Experience in psychiatric or behavioral health strongly preferred. Knowledge/Skills: Comprehensive knowledge of The Joint Commission (TJC), Massachusetts Department of Mental Health (DMH), Bureau of Substance Addiction Services (BSAS), and Centers for Medicare & Medicaid Services (CMS) standards and reporting requirements. Strong analytical, organizational, and project management skills. Ability to interpret regulations and accreditation standards and translate them into practice. Excellent written, verbal, and interpersonal communication skills. Proficiency in Microsoft Office Suite and data reporting systems.

Job Description We are searching for a Quality Assurance Manager for a great Monday through Friday opportunity in the city. Must have 10 year experience in food safety, sanitation, and compliance, quality control, training and development, and setting standards. Background must be in food and beverage/hospitality. Great balance and culture

Skanska is searching for a dynamic Quality Manager. This is a great opportunity to start a career with a company that builds things that matter and values its team. We are proud to share our culture of diversity and inclusion. The Quality Manager assists and supports Project Engineer, Project Manager, and Superintendent on assigned projects. He/she develops plans, directs, and supervises project quality control functions and activities in conformance with the Company or project required Quality Program. **Quality Manager Qualifications:** + Bachelor's Degree - Construction or Engineering or equivalent experience. + 5+ years prior relevant experience. + Advance knowledge of job area typically obtained through advanced education combined with experience. + Working knowledge of regulatory agency QA/QC requirements + Practical knowledge of project management. **Quality Manager** Benefits (********************************************************************************************************************************************************************************************* **of Working at Skanska:** + Competitive Salary range (based on experience) + Excellent Insurance Package + 401k w/match and Excellent Employee Stock Purchase Plan + An amazing culture focused on Diversity and Inclusion Our work makes a clear contribution to society and the environment around us. Whether we are building schools to provide inspiring spaces for learning, roads to connect communities or hospitals to care for patients, it all contributes to our purpose - we build for a better society. Skanska's values (***************************************************************************** -Be Better Together, Act Ethically and Transparently, Commit to Customer and Care for Life-are deeply engrained in how we work, which is why our values support and drive our D&I efforts. We are on a D&I (****************************************************************************** journey that is ongoing. It is a journey of continuous improvement-while we have come a long way, we still have more to go. **Come work with us and join a winning team!** **Background Check Required** Skanska is an Equal Employment Opportunity (EEO) Employer. We do not discriminate on the basis of race, color, religion, sex, national origin, disability, age, genetic information, citizenship, protected veteran status, or any other categories protected under applicable federal, state, and local laws. Skanska Equal Employment Opportunity Skanska uses knowledge & foresight to shape the way people live, work, and connect. More than 135 years in the making, we're one of the world's largest construction and project development companies. With operations in select markets throughout the Nordics, Europe and the United States, global revenue totaled $15.9 billion in 2024. Skanska in the U.S. operates 28 offices across the country, with its headquarters in New York City. In 2024, the U.S. construction sector generated $8.2 billion in revenue, and the U.S. development sector's net investments in commercial projects totaled $224 million. Together with our customers and the collective expertise of our 6,300 teammates in the U.S. and 26,300 globally, we create innovative and sustainable solutions that support healthy living beyond our lifetime. Skanska's Applicant Privacy Policy for California Residents (****************************************************************************************************************** **Search Firm and Employment Agency Disclaimer** _Search Firm and Employment Agency Disclaimer Skanska USA Human Resources ("Skanska HR") provides HR services to the Skanska business units within the U.S.A. including Skanska USA Civil Inc., Skanska USA Building Inc., Skanska USA Commercial Development Inc. and Skanska Infrastructure Development Inc. (collectively "Skanska USA"). As such, Skanska HR is the sole authorized representative of Skanska USA to execute any agreements with search firms, employment agencies or any employment vendor ("Vendor"). As a condition precedent to any entitlement for payment, a Vendor shall have both (1) Skanska USA Placement Agreement, and (2) an Engagement Job Order executed by an authorized Skanska HR representative. Absent the properly executed documents, Skanska HR shall have no obligation to make payment to the Vendor. Verbal or written communications from any employee of Skanska USA business units shall not be considered binding obligations. All resumes whether unsolicited or solicited shall be considered property of Skanska HR._

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

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

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

011230 CA-Provider Engagement & Performance The Program Manager, in collaboration with the Sr Director of Delegation Partnerships and Performance, is responsible for advancing provider quality performance across CCA's contracted network, with a focus on value-based arrangements and network-wide engagement strategies. The program manager is responsible for managing and implementing key population health and network quality initiatives to achieve high performance on CCA's Population Health goals; including Medicare Star measures, Medicaid-Medicare Plan withhold measures, quality performance metrics incorporated into other CCA contracts, health equity, Culturally and Linguistically Appropriate Services, Consumer Assessment of Healthcare Providers and Systems (CAHPS), and social determinants of health (SDOH) measures. The Program Manager will work collaboratively with our provider network and Quality teams to identify quality metrics that align contracting efforts for efficiency and effectives with alternative payment models. The Program This role serves as a critical bridge between Provider Engagement, Network Performance, Analytics, Clinical and Quality Teams to drive improvement in clinical outcomes, health equity, and member and provider experience. **Supervision Exercised** + No direct reports currently; however, one to three program consultants with future expansion. **Essential Duties & Responsibilities:** **Provider Quality Performance and Value-Based Care** + Lead implementation and monitoring of quality initiatives tied to value-based payment programs and contractual performance metrics. + Partner with Provider Engagement, Network, Clinical and Quality teams to evaluate provider performance, identify opportunities for improvement, and facilitate data-driven action plans. + Collaborate with Contracting, Quality Analytics, and Population Health to align provider quality measures with value-based contracts and incentive programs. + Translate quality performance data into actionable insights and communicate findings to provider partners to drive improvement. + Support the development and oversight of provider pay-for-performance programs, including metric tracking, financial reconciliation, and performance reporting. **Health Equity and CLAS Integration** + Partner with the Health Equity team to incorporate CLAS (Culturally and Linguistically Appropriate Services) standards into provider education and engagement activities. + Lead or support the development and dissemination of provider-facing resources that advance equitable care delivery. + Coordinate provider training and communication initiatives focused on social drivers of health, cultural competence, and equity-focused performance improvement. **CAHPS Strategy and Performance** + Oversee implementation of provider-focused initiatives that support CAHPS performance improvement. + Analyze CAHPS results to identify trends and collaborate with Provider Network, Clinical and Quality teams to address performance gaps. + Develop and disseminate provider education and best practices to improve member satisfaction with access, communication, and care coordination. + Track and report provider performance metrics related to CAHPS domains such as Getting Needed Care, Getting Care Quickly, Rating of Health Care, and Customer Service. + Collaborates with Communications to design provider materials and newsletters reinforcing CAHPS-related expectations and improvement goals. + Partners with network leadership to recognize high-performing providers and share improvement strategies. **Provider Education and Engagement** + Manage the design, scheduling, and delivery of provider quality education, including webinars, learning sessions, and quality performance updates in collaboration with Quality team. + Develop materials and presentations that clearly communicate quality goals, contractual expectations, and best practices to the provider network. + Serve as a trusted liaison to provider partners, responding to quality-related inquiries and facilitating collaborative discussions on improvement opportunities. **Performance Reporting & Data Management** + Partner with Quality Analytics and Business Intelligence to ensure timely, accurate, and meaningful quality performance reporting to internal teams and providers. + Monitor performance trends and support the creation of dashboards, summaries, and progress reports for internal and external audiences. + Maintain documentation, SOPs, and reporting schedules to support consistent quality operations. **Cross-Functional Collaboration & Strategic Support** + Collaborate closely with Provider Engagement, Contracting, Quality, and Clinical to ensure alignment on provider quality goals. + Participate in cross-functional workgroups focused on quality improvement, network performance, and member and provider experience. + Support strategic initiatives that promote continuous improvement and operational efficiency across the provider network. **Working Conditions** + Remote or hybrid working conditions. Position requires occasional travel in Massachusetts and the surrounding area. **Required Education** : + Bachelor's degree in healthcare administration, public health, business or health care related field **Desired Education:** + Master's degree + Certified Professional in Healthcare Quality (CPHQ) or equivalent certification **Required Experience:** + 5-7 years of experience in healthcare quality improvement, provider network performance and management, population health, or related area + Demonstrated experience interpreting and applying quality measures (HEDIS, CAHPS, HOS) and value-based contract performance metrics + Experience with Medicare Advantage, Medicaid; and dually eligible populations **Desired Experience** + Experience managing or supporting pay-for-performance or value-based care programs. + Experience leading provider education or training sessions. + Exposure to health equity initiatives and/or CLAS standards integration in provider settings. **Required Knowledge, Skills & Abilities:** + Strong understanding of provider quality performance frameworks and value-based care principles. + Working knowledge of claims data, quality measurement, and performance incentive methodologies. + Excellent verbal and written communication skills, including the ability to synthesize and present data effectively to providers and internal stakeholders. + Strong relationship management and interpersonal skills; ability to engage diverse provider partners diplomatically. + Proficiency with Microsoft Office Suite (Excel, PowerPoint, Word) and comfort working with dashboards and analytics tools. + Proven project management skills and ability to manage multiple priorities and deadlines. + Self-directed, detail-oriented, and able to work effectively in a fast-paced, matrixed environment. **Desired Knowledge, Skills & Abilities:** + Familiarity with quality analytics platforms, provider portals, or data visualization tools. + Working knowledge of health plan claims and payment policies, including provider reimbursement methodologies. + Experience applying CLAS standards or health equity frameworks within provider engagement or quality improvement initiatives. **Language(s)** + English **Compensation Range/Target: $99,600 - $149,400** Commonwealth Care Alliance takes into consideration a combination of a candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required for the role, and other external and internal data when establishing a salary level. In addition to base compensation, you may qualify for a bonus tied to company and individual performance. We are highly invested in every employee's total well-being and offer a substantial and comprehensive total rewards package. EEO is The Law Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled Please note employment with CCA is contingent upon acceptable professional references, a background check (including Mass CORI, employment, education, criminal check, and driving record, (if applicable)), an OIG Report and verification of a valid MA/RN license (if applicable). Commonwealth Care Alliance is an equal opportunity employer. Applicants are considered for positions without regard to veteran status, uniformed service member status, race, color, religion, sex, national origin, age, physical or mental disability, genetic information or any other category protected by applicable federal, state or local laws.

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.

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

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

The Director, GMP Operational Quality (Compliance) responsible for oversight of Commercial and/or Development Quality team activities, technical development of personnel, and ensuring the quality of deliverables and oversight of QMS system records (deviations, CAPA, and change controls) supporting cell and gene therapy programs. The Director is an advanced technical resource in the principles and application of quality assurance and compliance, has experience in participating in cross-functional teams working with deviations, root cause analysis, and CAPAs, as well as developing and communicating department QMS metrics and leading internal Tier meetings such as investigation and change control review boards. The incumbent is a key Quality and Compliance technical expert and assists with the strategic alignment of group and department goals, compliance and continuous improvement projects and activities, and refining and adapting processes and procedures as necessary through proactive monitoring/measurement. This position reports to the Sr. Director, GMP Quality Technical Services. This role is located at Vertex's Leiden Center Building (LC1), 316-318 Northern Ave, Boston, MA-02210. This role is an Onsite first shift position (Monday to Friday). Key Duties and Responsibilities: * Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions for development and commercial cell and gene products. * Participates in and drives improvements for Quality Leadership Team (QLT) and Quality Management Review (QMR) as applicable, including providing metrics and KPIs and leading CAPA and/or mitigations when metrics do not meet targets. * Acts as Quality Owner for major/critical deviations, including review and approval of associated CAPA, and coordinates with Manufacturing Technical Ops (MTO) to ensure assignment within QA team for minor quality events. Serves as Quality Lead for CAPA and Event Review (CERC) and Change Control (CC) committees. * Participates in cross-functional teams as an experienced Quality technical resource. * Assists Change Control owners with ensuring compliance to change procedure requirements, assesses and approves change controls as Quality. * Be the Quality triage and impact assessor of investigations/deviations, reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations. * Ensures appropriate CAPA actions are identified and addressed. * Maintains Quality Metrics to support process improvement activities * Proactively identify, assess and mitigate risks and gaps to cross-functional quality systems and technical quality processes. * Responsible for coordinating, facilitating and follow up on any Quality leadership team (QLT) action items assigned. * Supports audit programs and inspection readiness including assisting in preparation of audit responses for Cell & Gene Audits. * Act as a trusted advisor by providing compliance guidance through collaborative review and partnering with business stakeholders and contract manufacturers. * Execute improvements to QA operations processes. * Participate/ lead Cell & Genetic Program and Quality projects, including key member of Process Owner Network (PON), and drive continuous improvement activities. Knowledge and Skills: * Expert knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; expert knowledge of global GMP requirements and managing quality in support GMP manufacturing * Demonstrated success in building high-performing teams and skilled at managing team and individual development * Highly effective management skills with the ability to lead and motivate a team in a fast-paced environment while maintaining a high degree of quality, accuracy and timeliness * Substantial background in managing complex projects/teams within stated objectives and timelines and with a strong understanding of the underlying business drivers; skilled at applying project management processes / tools to lead meetings, assist with project planning, and facilitate attainment of project objectives * Expertly lead cross-functional teams and represent the interests, strategies and objectives of Quality unit * Substantial skills in mentoring staff and transferring technical knowledge to enable their capabilities and development * Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex concepts with the ability to influence leaders, customers, or vendors to adopt of a new point of view and/or to take action; negotiation skills may required * Demonstrated ability to evaluate unusually complex quality or multi-disciplinary matters and make decisions utilizing risk-based approach; identifies and leverages the appropriate expertise to implement solutions * Extensive experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA * Extensive exposure with multiple regulatory agencies across applicable GxPs during inspections * Substantial experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva) Education and Experience: * Bachelor's degree in a scientific or allied health field (or equivalent degree). * Typically requires 10+ years of work experience and 3 years of management experience, or the equivalent combination of education and experience. * Experience in Biologics and/or Cell and Gene commercial manufacturing quality. #LI-onsite #LI-JS1 Pay Range: $182,400 - $273,500 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: On-Site Designated Flex Eligibility Status: In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

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 .