Quality assurance manager jobs in Plainfield, NJ

Duration: 12 months The Quality Management Specialist II tasks include: CW shadows 3 ongoing studies and supports 7 ongoing studies (planning to reporting stage) to provide Quality oversight, to recommend best practices. Communicates and collaborates with the stakeholders (CM and FAs) partnering for cross-functional team support and attendance of project and study level meetings. With the assistance of Senior GCP Level 1 members, consults on major and critical quality issues, potential Serious Breaches, significant noncompliance, data integrity issues and protocol deviations, escalates to Senior Management, and performs periodic resolution checks for assigned studies. Supports risk assessments and risk-based approaches for the annual GQM Audit Plan, identifies the number of site audits and vendor audits based on risk-criteria with input from study teams. Provides study and site related information and documentation to the audit team, GCP Level 2 in preparation for audits. Participates in the risk assessment of preferred and active vendors utilizing risk assessment tools to prepare the annual GQM Vendor Audit Plan. Involved in CAPA review of Quality Issues, Audits, Inspections, eTMF audit responses. Participates and contributes to weekly, monthly, and quarterly GQM GCP meetings. Attends QA:QA and Quality Council meetings with CRO accompanied by a Senior Member from the GCP In-Line Quality (Level 1) Participates in the review and harmonization process of controlled documents such as protocols/ICF, CSRs, amendments, procedural documents & templates. Receives GCP training of ICH Guidelines E6 R3 and Modules from 21CFR and reads GCP Material. Team Members in training participate in weekly team support meetings. Involved in the Portfolio-wide proactive Inspection Readiness support (Sponsor, Site, CRO) - conducts Do & Don't training, participates in interview preparations/debriefs, assesses Inspection Readiness Visits and Pre-Inspection Visits outcomes. Reviews and assesses Pharmacovigilance System Master File (PSMF) and performs PV related activities as assigned. Qualifications: Bachelors Degree; preferably some Pharmaceutical background and GCP ICH E6 knowledge. About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit ************************ US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Recruiter Details: Name: Vicky Email: ********************************** Internal Id: 25-54443

JOB PURPOSE : Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that materials and products are inspected and released in compliance with cGMP guidelines, USP and FDA, EU requirements. Responsible for first shift QA In-Process and In-coming Groups, getting all the QA batch record documents approved for timely release of finished products and timely release of incoming materials. Work closely with Operations (Filling and Packaging) and other groups as necessary to troubleshoot issues in the warehouse, filling and packaging floors and ensure timely reporting of events. Work closely with compliance group at times of external audits (FDA or vendors). Ensure that non-compliant situations are thoroughly investigated. KEY ACCOUNTABILITIES: Regular and predictable onsite attendance and punctuality. Directs the incoming and in-process QA groups. Makes final accept/reject disposition on incoming materials, including but not limited to raw materials, components, production commodities. Assures batch is manufactured Ensures that records are reviewed and released in a timely manner. Coordinates communication for status of incoming materials and resolves issues related to accept/reject disposition of materials. Coordinates communication of production status to next shift; attends daily update meetings as required. Manages personnel for in-process filling and inspection/packaging monitoring. Provides QA review and approval of manufacturing investigations, as necessary, assuring timely review, follow-up, tracking and trending of MIRs. Provide guidance to the investigator, as required Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents. Expedites and prioritizes product releases by coordinating the Review of QA documentation to meet customer service requirements. Conducts routine investigation and departmental meetings to facilitate the performance of release function, with respect to incoming materials. Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff. Places lots on HOLD if Quality issues are detected and notifies senior management. Assists the QA management in developing on department budget. Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions. Manages attendance records for all direct reports. QUALIFICATIONS: College Degree within a science related discipline such as a B.S. in Pharmacy, Science, Engineering or other related fields is required with 10+ years' experience, or Masters' Degree in Microbiology, or biological science with 3-6 years' experience Ph.D. in relevant field with 0-3 years' experience Preferred: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial EXPERIENCE: Minimum: Experience in the Pharmaceutical Industry in the field of Quality Assurance or Production is a must SKILLS: Must have history of strong documentation skills and attention to detail Familiarity with cGMPs and CFR for US and EU Excellent organizational skills and ability to multi-task and perform work in a timely manner Demonstrates ability to lead a department, projects and meetings effectively Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management General computer skills and ability to prepare presentations and address large groups Demonstrated attention to details and accuracy The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must Mentoring abilities as well as effective communication, (written and oral) are required. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

A New Jersey-based services company is actively seeking a new UKG/Kronos Test Lead to join their team in East Rutherford on a contract basis. Responsibilities: Assist business functional resources on ensuring that all company specific test cases are identified and being tested. Assist business function resources with connecting individual testing activities into end to end execution for major processes Identify any test case execution that is behind plan and escalating to Leadership as to potential additional resource needs for completion Provide daily metrics and tracking as to test completion and defects Ensure that all defects are prioritized and included in daily metrics for any showstoppers or critical ones. Ensure UAT environment is in sync with all test cases Qualifications: Experience supporting UAT or system testing in a business-driven environment Ability to partner with business stakeholders to identify, validate, and execute all required test cases Experience coordinating end-to-end testing across major business processes Strong tracking and reporting skills, with the ability to identify delays, risks, and resource gaps and escalate as needed Hands-on experience delivering daily test metrics, including execution status and defect tracking Solid understanding of defect prioritization, with a focus on critical and showstopper issues Experience ensuring UAT environments align with test case requirements Strong communication, organization, and stakeholder management skills

Seeking Salesforce Test Lead As a Salesforce Test Lead you will act as a validation and quality assurance expert and review the functionality of existing systems. You will conduct requirement analysis, define test strategy & design and lead execution to guarantee superior outcomes. You will have the opportunity to collaborate with some of the best talent in the industry to create innovative high quality and defect-free solutions to meet our clients' business needs. You will be part of a learning culture, where teamwork and collaboration are encouraged, excellence is rewarded, and diversity is respected and valued. Required Qualifications: Bachelor's degree or foreign equivalent required from an accredited institution. Will also consider three years of progressive experience in the specialty in lieu of every year of education. At least 7+ years of Information Technology experience Candidates authorized to work for any employer in the United States without employer-based visa sponsorship are welcome to apply. Unable to provide immigration sponsorship for this role at this time. Candidate must be located within commuting distance of Pennington, NJ or be willing to relocate one of these areas. This position may require travel in the US and Canada. Experience in Software Development and Software Development life cycles (Waterfall/Agile) Preferred Experience: 4+ years of relevant experience in Salesforce Testing and Automation. Have knowledge and relevant experience in Sales Cloud, Service Cloud, Marketing Cloud and Experience Cloud. Experience in Sales Cloud, Service Cloud, Marketing Cloud and Experience Cloud. Experience in Automation - Selenium, Provar, Copado CRT etc. Experience with Writing Testing Strategies, Test Plan and Hands-on Test Execution (as required) Participate in test planning and preparation, represent QA team in scrum calls. Prepare Test Plan for the project. Prepare and share the Effort Estimation for manual as well as automation. Perform System Testing, System Integration Testing, End to End Testing and Automation. Record test evidence - sufficient to demonstrate test coverage. Raise defects and take ownership until resolution. Work with business users to refine test approach, as required. Defining the Automation standards and best practices to be followed. Conducting Feasibility analysis for Test cases to be automated. Maintaining Traceability between requirements and automation scripts. Guiding the Team in creating automation scripts. Review test cases, test scripts, execution, and test results. Produce Test Completion Report. Undertake defects prevention activities. Interface with customers for issue resolution and review knowledge management activities. Escalating risks/issues to Program Manager/Product Owner. Strong analytical, problem solving and Presentation Skills with strong Interpersonal and organization skills. Experience with version control systems (e.g., Git) and continuous integration/continuous deployment (CI/CD) pipelines. Good hands-on experience in other tools like Selenium, Copado CRT, JIRA, Azure DevOps.

Job Title: Test Lead - Functional Testing (Mainframe) We are seeking an experienced Test Lead - Functional Testing with strong mainframe testing and environment support expertise. The role focuses on end-to-end (E2E) functional testing, test automation, and backend environment support across complex mainframe systems. The ideal candidate will act as a lead and escalation point, ensuring testing quality, SLA adherence, and environment stability. Key Responsibilities Lead functional and end-to-end testing, participating in client and technical discussions to understand requirements and risks. Plan and maintain test strategies, test cases, and test suites, ensuring adherence to quality standards. Develop and enhance test automation scripts and frameworks using tools like Selenium and TestNG. Provide E2E testing and environment support for mainframe systems, including batch monitoring, root cause analysis, and file transmission support. Act as an escalation point for testing and environment issues, managing incidents and ensuring SLA compliance. Collaborate with QA, development, and infrastructure teams, and provide status and risk reporting to stakeholders. Technical Skills Required Mainframe Technologies: COBOL, JCL, DB2, VSAM Online Systems: CICS (preferred) Operating Systems: Linux, AIX Job Scheduling: CA-7 Testing & Support: End-to-End Testing, Environment Management, File Transmission Monitoring Automation Tools: Selenium, TestNG (or equivalent) Database Testing & Data Validation Preferred Qualifications Strong hands-on experience in mainframe batch and online systems Experience in client-facing or production support roles Excellent communication, coordination, and leadership skills Certifications (Optional but Preferred) ISTQB Certified Tester - Foundation Level Test Automation Certification (e.g., Certified Selenium Tester)

Join a growing and trusted pharmaceutical organization dedicated to advancing quality in sterile drug production. As a QA Manufacturing Specialist, you'll provide direct quality oversight of production operations, ensuring alignment with cGMP guidelines as defined under Section 503B. This role supports compliance in compounding, filling, inspecting, and packaging processes by monitoring critical procedures and documentation. Ideal for detail-driven individuals eager to contribute to regulatory excellence and patient safety. RESPONSIBILITIES Monitor daily production floor activities including compounding, aseptic filling, visual inspection, and packaging to uphold quality standards Ensure cleaning protocols are thoroughly followed and documented in manufacturing areas Approve product labels and ensure compliance prior to use Conduct verification of line clearance, material status, aseptic techniques, and documentation during filling operations Ensure personnel follow proper gowning procedures across all production zones Identify and document quality events such as deviations, initiate CAPAs, and manage change controls Represent QA interests during audits and inspections as needed Assist with root cause investigations to drive continuous improvement Maintain detailed and accurate batch records, logs, and compliance documentation Adhere to company policies and support additional duties as needed QUALIFICATIONS Minimum 3 years of experience in quality assurance within aseptic drug manufacturing, preferably in a 503B outsourcing facility High school diploma required; BS in a scientific discipline preferred Solid understanding of cGMP, Good Documentation Practices, and pharmaceutical quality systems Knowledge of manufacturing operations, automation, and cleanroom practices Proficient in Microsoft Office (Word, Excel, PowerPoint); ability to learn new systems as required Effective communication skills with ability to work independently and under time-sensitive conditions Adaptable to rotating shifts, weekend schedules, and holiday coverage if required Physical ability to lift up to 25 pounds and wear required cleanroom attire, including scrubs, gloves, and safety footwear Comfortable working in cleanroom environments and with hazardous substances as necessary

Mandatory Technical / Functional Skills • Software Quality Assurance consultant with at least 10 years' experience in playing QA Director Technical/Functional Skills • Experience in formulating QA strategy and leading QA execution for large programs • Ability to play advisory role to customer on how to manage testing in an end to end scenario (right from planning and requirement phase to User acceptance testing) • Excellent understanding of QA metrics, entry/exit criteria • Experience in Insurance or Financial services industry sector will be good to have Roles & Responsibilities • Formulate Software Quality Assurance strategy (QA and UAT) • Establish quality standards • Establish quality documentation by writing and updating quality assurance procedures • Participate in Requirement analysis, Test strategy sessions of the program to understand and gather the necessary details to ensure its alignment to quality strategy, standards and procedures • Review all the program testing deliverables across Software Testing Life Cycle (STLC) • Ensure testing deliverables completeness on test scope coverage • Ensure program testing schedule is realistic •Ensure traceability on program requirement to test cases & result • Perform root cause analysis and create pattern to identify frequently occurring defects • Arrange review finding walk-through sessions, publish detail review findings • Provide corrective actions/recommendations/best practices in reducing defect trend • Track closure of review findings and implementation of actions/recommendations • Ensure program testing risks and assumptions are clearly articulated • Create and publish program quality dashboard Thanks & Regards, Additional Information If you are comfortable with the position and location then please revert me back at the earliest with your updated resume and following details or I would really appreciate if you can call me back on my number. Full Name: Email: Skype id: Contact Nos.: Current Location: Open to relocate: Start Availability: Work Permit: Flexible time for INTERVIEW: Current Company: Current Rate: Expected Rate: Total IT Experience [Years]: Total US Experience [Years]: Key Skill Set: Best time to call: 2 Slots for phone interview: In case you are not interested, I will be very grateful if you can pass this position to your colleagues or friends who might be interested. All your information will be kept confidential according to EEO guidelines.

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 :195,000-256,000Under 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

Gourmia stands as a trusted name in the world of kitchen appliances, focusing on innovative, quality-driven products that cater to modern culinary needs. Our diverse product range of air fryers, smokeless grills, and other kitchen innovations are prominently displayed on the shelves of major retailers like Walmart, Costco, and Target. We're not just about products, though; we're about people. Our team, drawn from diverse backgrounds, collaborates daily to design and produce appliances that make cooking simpler and more efficient. We value a culture of mutual respect, learning, and growth, ensuring that every member feels valued and has the resources they need to succeed. When you join Gourmia, you're not merely finding a place of work but an environment where your skills are nurtured, your efforts are recognized, and your professional growth is a shared priority. We believe in doing things the right way - not just in our products, but in our commitment to our team's well-being and development. Come be a part of a grounded, future-focused company that's dedicated to quality, innovation, and its people. Job Description Job Purpose: To lead and manage a team of R&D Engineers and QC/QA technicians in designing and producing innovative small kitchen appliances. The Director will utilize their engineering expertise to oversee resource and timeline management, ensuring efficient product development, market introduction, and ongoing quality management. Job Duties: · Lead the Engineering team in modeling, prototyping, and finalizing designs of new small kitchen appliances, ensuring designs align with requirements from R&D. · Develop standards and SOPs for QC/QA for new and existing products to ensure achievement of quality requirements. · Oversee project timelines within Engineering, ensuring timely delivery of products from conception to market. · Collaborate with cross-functional teams to integrate insights from market research and customer feedback into product engineering and ongoing QC/QA. · Drive innovation and continuous improvement in product technical parameters, testing processes, and quality standards. Qualifications · Proven experience in Engineering Management within the household appliance industry, or another industry driven by mechanical and electrical engineering. · Strong leadership skills with experience managing a team of engineers, both in the US and China. Education: · Master's degree in Engineering or a related field is preferred. Experience: · Minimum of 7 years of experience in electrical and mechanical engineering, with at least 3 years in a leadership role. Knowledge and Skills: · In-depth knowledge of small appliance design and development. · Excellent project management skills. · Strong problem-solving and analytical abilities. · Proficient in relevant software and engineering tools. Preferred Qualifications: · Experience in small kitchen appliance R&D. · Familiarity with the latest trends and technologies in the industry. · Bilingual English and Mandarin is a plus. Additional Information Working Conditions: · Office-based role with occasional travel to manufacturing sites or industry events. · Collaborative team environment with opportunities for professional growth. Compensation: $160,000 - $200,000 annually

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

Job Description Community Federal Savings Bank (CFSB), located in New York City is seeking a highly skilled and detail-oriented Head of Financial Crimes Compliance Quality Assurance to join our Program Management & Assurance function within the Compliance department. CFSB offers a full range of banking services including ACH settlement services, pre-paid card issuance, and retail banking. In addition to serving our general customer base, we also service various types of money service businesses and FinTech companies. This individual will be primarily responsible for overseeing a robust quality assurance program to ensure compliance controls are operating as designed. They will drive strategic Financial Crimes Compliance QA initiatives, enhance transparency, and provide data-driven insights to inform decision-making and regulatory readiness. Key Responsibilities: Enhance and maintain the Financial Crimes Compliance Quality Assurance (QA) framework to assess whether key compliance control activities-conducted internally or by external consultants-adhere to internal standards, regulatory expectations, and Bank policy. Implement and continuously refine standardized QA test scripts, workpapers, and documentation templates to drive consistency, transparency, and auditability across QA reviews. Lead and develop a high-performing team of Financial Crimes Compliance QA Managers and staff, providing coaching, mentorship, and oversight to ensure effective execution and professional growth. Partner with Internal Control functions to align Financial Crimes Compliance QA insights with broader risk trends, inform planning cycles, and enhance control evaluations across business units. Stay current on regulatory developments, enforcement actions, and industry best practices; translate regulatory changes into QA control enhancements and update procedures accordingly. Provide structured, actionable feedback and guidance to control owners and business partners based on QA findings, supporting the adoption of practical, risk-aligned solutions and best practices. Lead the design and delivery of training content and workshops to improve the quality, consistency, and defensibility of investigations, control execution, and documentation. Establish Financial Crimes Compliance QA metrics and dashboards to support continuous improvement, trend analysis, and executive-level reporting to governance committees, senior leadership, and regulators. Ensure Financial Crimes Compliance QA processes integrate technology and data analytics where feasible to improve efficiency, risk detection, and traceability. Act as a strategic partner across Compliance, Legal, Audit, Operations, and Technology to promote a culture of accountability, transparency, and continuous improvement. Support internal and external regulatory examinations by providing Financial Crimes Compliance QA reporting, documentation, and commentary as needed. Qualifications: Deep subject matter expertise in regulatory compliance, quality assurance methodologies, and risk management within the financial services industry. Proven ability to design and lead Financial Crimes Compliance QA programs in complex, matrixed environments involving third-party partnerships, fintech platforms, and high-risk product offerings. Demonstrated experience presenting Financial Crimes Compliance QA findings, thematic trends, and risk insights to executive leadership, Board-level committees, and regulatory agencies. Strong working knowledge of BSA/AML/OFAC requirements. Strategic mindset with the ability to drive long-term program maturity while executing detailed operational reviews and initiatives. Proficient in leveraging technology platforms to support Financial Crimes Compliance QA activities, including GRC systems, workflow tools, and automated testing solutions. Exceptional written and verbal communication skills, with the ability to translate complex compliance matters into actionable, business-aligned recommendations. Collaborative leader with a track record of building high-performing teams and influencing cross-functional partners across Compliance, Legal, Risk, Operations, and Technology. Bachelor's degree required; advanced degree (e.g., JD, MBA) or relevant professional certifications (e.g., CAMS, CRCM, CISA, CFE) strongly preferred. Minimum of 10 years of experience in Compliance, Audit, Risk, or Internal Controls, with at least 5 years in a senior leadership or QA oversight role. Prior experience overseeing Financial Crimes Compliance QA or testing programs focused on consumer protection, AML, sanctions, or third-party oversight is highly desirable. Exposure to dynamic and hybrid business models, such as banking-as-a-service (BaaS), money service businesses (MSBs), fintech partnerships, or international payments, is strongly preferred. Salary: $180,000 - $210,000 K / year "Base salary range does not include performance-based bonus and/or other benefits, where applicable. Actual base salary offer will vary based on skills and experience." About Community Federal Savings Bank (CFSB) Community Federal Savings Bank (CFSB) is a federally chartered bank founded in 2001 and headquartered in New York City. CFSB has focused on providing superior service and added value to clients though a solid understanding of relationship banking. We offer a full range of services, including loans, bill payments, card services, internet banking, and merchant processing. We are an equal opportunity employer and do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, military and/or veteran status, or any other Federal or State legally-protected classes.

Meet Our Team: The Senior Director Finance role is an exciting opportunity to be a key leader serving as a member of the India Leadership team and Global Finance team supporting a dynamic and high growth organization. This is a multi-faceted role handling a large team working in a highly matrixed-structure. Picture Yourself at Pega: In this role you will establish strong processes and controls that enable the group to deliver high quality results. The position not only has the responsibility of looking inward, but also to keep an eye outwards and apprise the business and key stakeholders of any threats and opportunities arising out of any economic, political or any other changes in India/APAC. What You'll Do at Pega:• Manage the APAC financial closing process - work cross-functionally and coordinate everyone's efforts to ensure that all required financial data is properly captured, reconciled, documented, and disclosed.• Ensure that all APAC financial data is in compliance with Generally Accepted Accounting Principles (GAAP).• Ensure that monthly close deadlines for US SEC reporting purposes are met.• Develop and maintain accounting policies and procedures including process documentation and control matrices.• Review and approve APAC accounting transactions; responsible for overseeing APAC general ledger, sub-ledgers and fiscal records.• Manage the fixed asset systems.• Manage APAC operating cash, the weekly bank reconciliation, and reporting.• Direct and coordinate financial planning and budget management functions• Recommend benchmarks for measuring the financial and operating performance• Monitor and analyze monthly operating results against budget• Oversee daily operations of the finance and accounting department Who You Are: A highly proficient senior leader who can inspire, build, and retain a highly engaged, efficient and motivated team. Has strong analytical and project management skills to be able to allocate resources well and influence, build consensus, and resolve conflicts as required. Support a team-oriented environment, ensuring that all tasks are being completed timely and accurately. What You've Accomplished:• CA (Chartered Accountant) with strong experience in working within the technology industry• 15+ years' experience across finance, accounting, budgeting, and cost control principles including U.S. and India Generally Accepted Accounting Principles• Knowledge of automated financial and accounting reporting systems.• Knowledge of federal and state financial regulations• Ability to analyze financial data and prepare financial reports, statements and projections• Small and large project/program orientation• Ability to motivate teams to produce quality materials within tight timeframes and simultaneously manage several projects. Pega Offers You:• A rapidly growing yet well-established business• The world's most innovative organizations as reference-able clients• Analyst acclaimed technology leadership in a massive emerging market• A workplace that requires people to have an informed opinion

Under the direction of the Vice President, the Director of Ambulatory Care Quality plans, implements, and directs quality improvement and patient experience initiatives across all SBH Ambulatory Care sites. The Director is responsible for developing and managing action plans to improve performance on quality metrics, maintain regulatory compliance, and enhance the patient experience. The position leads the governance and facilitation of the Ambulatory Quality Committee and the Ambulatory Patient Experience Workgroup. The role oversees performance improvement projects, chart audits, documentation reviews, and new workflow implementations to enhance outcomes and patient-centered care. The director also assists the VP with departmental compliance programs and reviews. Responsibilities: Provides leadership to the Ambulatory Care Quality & Population Health department, supporting the VP with department strategy, operations and management. Prepares and facilitates the Ambulatory Quality Committee, including agenda development, data reporting, and tracking of follow-up items and performance improvement plans. Prepares and facilitates the Ambulatory Patient Experience Workgroup, including agenda development, data reporting, and tracking of follow-up items and performance improvement plans. Designs and implements quality assurance and performance improvement (QAPI) initiatives to improve patient care, advance population health, and drive value-based care outcomes. Supports Ambulatory Care Directors and leaders to implement QAPI initiatives in their own areas, and to develop QAPI reports and Performance Improvement posters. Develops training content and performance feedback tools to coach ambulatory providers and staff on quality improvement best practices. Leads internal audit processes, regulatory survey readiness (e.g., Joint Commission, NCQA, NYS DOH), and documentation compliance reviews. Assists the VP with departmental compliance programs and reviews including chart and billing audits, and investigations. Performs other related duties at the discretion of the Vice President. Attends scheduled department and division meetings and participates as appropriate.

The Director of Quality Assurance & Training ensures appropriate and effective monitoring of existing procedures of program operations and delivery of services. The position also maintains an ongoing staff training program to ensure that staff are up to date on policies, procedures, and enhanced service practices. What You'll Do Create SOPs and Desk Guides for new and existing programs, reviewing and updating materials for programs and conducting training with staff to ensure understanding and compliance with both funder and Fedcap requirements. Develop and maintain an annual report that provides a thorough description of Fedcap's Quality Assurance activities with an established Quality Improvement Plan (QIP) model. Develop and implement quality assurance tools to measure and assess the impact of systems, policies and protocols on operational efficiencies and program effectiveness. Conduct site visits to observe staff interaction with participants including intakes, service plan creation, and workshops. Review case files for completeness, accuracy, and compliance. Monitor Customer Service standards including conducting participant focus groups and analyzing surveys to gather feedback and increase awareness of participants' perspective of program services. Prepare monthly and quarterly reports for Senior Leadership and regulatory bodies. Identify gaps in program and staff performance and designing and conducting staff training to cure deficiencies and reiterate company standards. Develop and conduct training programs to provide to WeCARE operations staff on various policies, procedures, and best practices. Research and continuously update training modules on various topics relevant to providing the best possible services to WeCARE participants. Assist with external audits conducted by funders and third-party auditors. Conduct safety and risk assessment to ensure compliance with ADA and regulatory standards at service locations. Work collaboratively with program departments, external agencies and stakeholders to support compliance efforts and monitor remediation (Corrective Action) activities. You're a great fit for this role if you have: A bachelor's degree in public health, public administration, human services, or a related field, with master's degree preferred. At least 2 years' experience in quality assurance, preferably in social services, public health, or workforce development. Experience with workforce development is a plus. Compensation $120,000-$130,000 The Fedcap Group 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. We are an EEO employer committed to diversity, M/F/D/V.

Job DescriptionJob Title: Quality Manager - Food Manufacturing About the Role: We are seeking a dedicated and experienced Quality Manager to join our team in the food manufacturing sector. The ideal candidate will be responsible for ensuring that our products meet the highest standards of quality and safety. You will lead quality assurance initiatives and drive continuous improvement across all production processes. Key Responsibilities: Develop, implement, and maintain quality assurance protocols and procedures specific to food manufacturing. Oversee the quality control processes to ensure compliance with industry standards and food safety regulations. Collaborate with cross-functional teams to identify and resolve quality issues. Conduct regular audits and inspections to ensure adherence to quality standards and regulatory requirements. Analyze data and reports to identify areas for improvement and implement corrective actions. Lead and mentor the quality assurance team to achieve departmental goals. Liaise with suppliers and vendors to ensure quality standards are met throughout the supply chain. Qualifications: Bachelor's degree in Food Science, Quality Management, Engineering, or a related field. Proven experience as a Quality Manager or similar role in the food manufacturing industry. Strong knowledge of quality assurance methodologies and food safety standards (e.g., HACCP, ISO 22000). Excellent analytical and problem-solving skills. Strong leadership and communication abilities. Experience with quality management software and tools. Attention to detail and a commitment to excellence. Preferred Skills: Certification in quality management or food safety (e.g., Six Sigma, CQE). Familiarity with regulatory requirements relevant to the food industry.

Job Description QUALITY MANAGER Salary: $120,000 PLUS, depending on experience Seeking a hands-on, highly experienced Quality Manager to lead and continuously improve an AS9100-certified Quality Management System within an aerospace and industrial manufacturing environment. This role requires a strong, tenured Quality leader with expert-level AS9100 experience gained in a manufacturing or job shop setting and the ability to interface confidently with leadership and external auditors. Experience in food or pharmaceutical industries not a good match for this role. REQUIREMENTS 7+ years of Quality Management experience in a manufacturing or job shop environment Demonstrated stability and strong tenure with prior employers Expert-level AS9100 experience, including hands-on ownership and audit leadership ISO 9001:2015 experience Aerospace, defense, or ITAR-regulated manufacturing background Machining experience with a strong understanding of inspection tools (calipers, micrometers, CMM, optical comparator) Excellent blueprint reading and GD&T interpretation skills Experience with PPAP, FMEA, Root Cause Analysis, and Control Plans Exposure to Environmental, Health, and Safety (EHS) standards Professional presence with the ability to interface with executive leadership and auditors Bachelor's degree preferred; equivalent experience welcomed BENEFITS Medical, dental, vision, and life insurance Paid time off, holidays, and sick time 401(k) plan Long-established, financially stable aerospace and industrial manufacturer located in Westchester County, NY.

Haddad is a privately held family business with 100 years' experience in the children's apparel & accessories industry. A leader in the children's wear industry, Haddad Brands is the exclusive global licensee for the most iconic brands in the world, which include Nike, Jordan, Converse, Hurley, Levi's, Polo, Abercrombie and Fitch, Lacoste, Tommy Hilfiger, Calvin Klein and Huggies. Supported by a team of professionals skilled in design, sourcing, production, sales, marketing & distribution of premium quality children's wear, Haddad distributes globally to 100+ countries and maintains sales and sourcing offices in 22 cities globally, including New York, Paris, Hilversum, Shanghai, Egypt, Bangkok, Vietnam, Sri Lanka, London and Montreal. Overview: The International Quality Manager supports global Quality Control operations by providing leadership, oversight, and coordination of product quality execution across all international regions. This role provides assistance with ensuring consistency of standards, alignment with customer requirements, and effective implementation of global QC initiatives. The manager works closely with director of quality control to strengthen overall product quality. Domestic and international travel is required. Key Accountabilities: Support global QC team initiatives by implementing company quality standards across all international regions Provide guidance to regional QC teams to ensure consistent inspector performance, inspection accuracy, and procedural compliance Partner with overseas managing offices and factory management to resolve quality issues, support corrective actions, and improve factory outgoing product quality Review and analyze global and domestic inspection reports, defect trends, and quality metrics to identify areas for improvement Visit factories as required to review production, evaluate quality risks, and verify corrective actions Communicate critical quality findings and risk assessments to the Director of Quality Control and other cross-functional leaders Support retailer chargeback prevention through compliance oversight and documentation accuracy Partner with the Director of Quality control to develop and refine global QC processes, manuals, and training materials Provide pre-production and inline quality support to factories to reduce final inspection failures Maintain consistent quality communication channels between domestic and international teams Recruit top talent, train and develop team members Special projects as assigned Requirements Required Skills/Abilities/Education: Bachelor's degree in Quality Management, Manufacturing, Engineering, or related field preferred 5-7 years of experience in Quality Control or Quality Assurance within apparel, or consumer products Strong knowledge of global manufacturing processes, inspection methods, and quality assurance systems Prior experience working with overseas factories and international QC teams Excellent communication, coaching, and cross-cultural collaboration skills Strong analytical and problem-solving abilities with attention to detail Ability to work independently across multiple regions and time zones Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook) Ability to travel domestically and internationally as required Consistent in-office presence is vital to the role as it is for all Haddad Brands team members, so that we all have a full appreciation, aesthetically and tactilely, of the qualities that define our brand partners' products and set them apart from their competitors. Salary Description $80,000 - $100,000 per year

OVERALL RESPONSIBILITIES: Customer Quality member responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include intake, investigation, documentation, follow-up, regulatory reporting and metrics. The Customer Quality Specialist is responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. The Customer Quality Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development and other functional experts. DUTIES: • Responsible and accountable for on-time submission and accuracy of regulatory reports • Review and complete determination associated Medical Device Report and/or Vigilance Report • Knowledge of and familiarity with global regulations for reporting • Directly interface with service centers, Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events • Interact positively with internal, external business partners and colleagues • Adhere and comply to work instructions, standard operating procedures, and regulations • Expedite investigations by collaborating with internal/external business partners • Achieve productivity targets • Fully trained within three months of hire • Achieve accuracy targets for complaint documentations • Participate in projects and events • Complaint determination • Reportability assessments • Conduct follow-ups with complainant, reporters • Checking your own work • Updating SharePoint • Tracking complaints in the process for closure • All other duties as assigned Qualifications • Bachelor's Degree or equivalent experience • Generally requires 2-4 years of related work experience • RAC or ASQ certifications a plus Additional Information All your information will be kept confidential according to EEO guidelines.

The Clinical Research Quality Control Manager is a senior leader responsible for the strategic oversight, planning, and execution of all quality control activities within the clinical research unit. This role ensures that clinical trial processes, documentation, and regulatory submissions consistently meet internal standards and external regulatory requirements. The manager leads QC reviews, identifies non-conformances, drives process improvements, and mentors QC staff. RESPONSIBILITIES Strategic Leadership & Oversight Develop, implement, and maintain a comprehensive quality control program for clinical research activities. Lead and mentor QC staff, providing guidance, training, and performance management. Serve as the subject matter expert for QC processes, regulations, and best practices. Quality Control Operations Oversee QC review of clinical documents (source documentation, regulatory binder, pharmacy binder, laboratory binder, presentation materials, and clinical sections of regulatory submissions). Ensure all clinical processes comply with applicable regulations, SOPs, laboratory manuals, and study protocols. Oversee alignment of processing forms and shipping manifests with SOPs and protocols. Attend key study visits to ensure quality and compliance. Follow up on outstanding source documentation review issues with designated staff. Maintain and utilize QC tracking logs for live QC activities. Continuous Improvement & Risk Mitigation Identify non-conformances during clinical trial conduct and lead root cause analyses. Develop and implement risk mitigation strategies and corrective action plans. Drive ongoing process improvement initiatives. Training & SOP Development Lead the writing and review of clinical quality-related SOPs. Regulatory & Compliance Ensure correct IRB-approved informed consent forms and subject source documents are used. Communicate with operational departments regarding project status and issues. Ensure compliance with current Good Clinical Practices (cGCPs) and corporate policies. Strategic Planning & Vision Develop and execute the long-term vision and strategy for quality control across all clinical research programs. Align QC objectives with organizational goals and regulatory trends. Organizational Leadership Lead and manage multiple QC teams or units across sites, ensuring consistency and excellence in QC practices. Oversee recruitment, development, and retention of QC staff; set performance standards and conduct evaluations. Cross-Functional Collaboration Serve as the primary QC liaison to executive leadership, regulatory affairs, clinical operations, and external partners. Lead cross-functional committees focused on quality, compliance, and process improvement. Other Duties Perform other QC-related duties as assigned. TRAVELING Between Corporate New Jersey and New York locations, as needed. Salary Range: $85,000-$95,000 annually. Final compensation is based on skills, experience, location, and overall expertise. Requirements Education: Bachelor's degree in a relevant field (e.g., Life Sciences, Chemistry, Biology, Nursing, or related discipline) required; advanced degree preferred. Experience: Minimum 5 years of progressive experience in clinical research quality control or related field, with at least 2 years in a leadership or management role. Deep knowledge of clinical research processes, regulatory requirements, and QC methodologies. Proven leadership and team management abilities. Excellent communication, analytical, and problem-solving skills. Strong organizational and project management skills. Ability to provide accurate documentation and drive process improvements.