Quality manager jobs in Edison, 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

Quality Manager(Food Manufacturing) Food and beverage industry Certificate, HACCP and PCQI In-depth knowledge of FDA regulations, ISO 9001, ISO 13485, and HACCP principles. Strong experience in QA/QC processes including conducting quality audits. Are you looking to make a career change to a rapidly growing company? This exciting opportunity offers a competitive salary plus an excellent benefits package including medical insurance, dental insurance and paid PTO. Does this position match your future career goals? Then this opportunity could be the right fit for you Very Competitive Benefits Package Excellent Growth and advancement opportunities Employment Type: Full-time Job Requirements and Duties: Bachelor's degree in Science 5 plus years of food manufacturing industry experience Certificate, HACCP and PCQI Preventive Controls Qualified Individual (PCQI) in accordance the Food Safety Modernization Act (FSMA) Preventive Controls for Human Food Rule In-depth knowledge of FDA regulations, ISO 9001, ISO 13485, and HACCP principles. Strong experience in QA/QC processes including conducting quality audits. Manage the Food Fraud Program and Plant Security/Vulnerability Programs Assist in New Customer Setups by verifying internal documentation matches customer specification requirements Write, maintain, and improve quality system SOPs Provide oversight and leadership of facility Quality Assurance team. Responsible for hiring and team member development Manage the day to day operation of all quality function Lead the team in the execution of HACCP plans and ensure proper documentation is maintained Ensuring that manufacturing processes comply with standards at both National/ International level Review SOPs & specifications Oversee all aspects of daily quality operations Manage budgeting Ensure compliance with Federal, State and Local food safety regulations Understanding of industry standards of Food Safety and Quality Supports and participate to all the internal/external audits Review test results Provide, and oversee, inspection activity for product throughout production cycle Apply total quality management tools and approaches to analytical and reporting processes Schedule and coordinate preparations for product inspections and testing Work to resolve noncompliance issues with materials or final product Exceptional interpersonal skills and organizational skills Benefits: Great Pay Very Competitive Benefits Package Excellent work environment with growth opportunities Immediate Hire Jasleen Kaur ********************************* Ajulia Executive Search is a search firm specializing in Manufacturing, Finance, IT, Legal and Pharmaceutical positions. This is a confidential search for one of our preferred clients. It is a direct hire position that includes competitive compensation and full comprehensive benefit package. #ZR

Work Shifts 9:00 A.M - 5:00 P.M Duties & Responsibilities Under the direction of the Budget Director (Corporate), compiles, administers and obtains approvals of the Capital Facilities Budget; evaluates project proposals, monitors and reports regularly on project status; maintains Corporation records of funds, contracts and cash outlays. Develops, recommends and implements criteria and procedures to improve the effectiveness of the Corporation's facilities improvement programs. Examples of Typical Tasks Directs annual budget cycles which include receipt and program and fiscal analysis of capital requests and Article 28 applications from health care facilities. Evaluates requests and makes recommendations to Director of Planning for funding and work orders. Obtains approvals of Capital Budget, Programs and Contracts from the City, Board of Estimate, Financial Control Board, HSA and State Health Department. Generates project cost data and establishes criteria procedures necessary to maintain a sound investment strategy and to sustain effective participation by the hospitals, community boards and regulatory and financing agencies in our facilities improvement programs. Monitors and reports regularly on Capital project status to the Corporation and the City of New York using a computerized Management Information System. Maintains records of capital funds, expenditures and cash outlays. Certifies capital funding for expenditures and estimates costs for fixed asset accounting and reimbursement reporting. Interfaces with City Comptroller and land and construction agency records to establish costs of construction, debt management and related services furnished by the City for Corporation purposes and maintains separate records of these cost auditable to City source records. Assists in audits of financial records as required by the Corporation, the City Comptroller, City Construction Board, State Emergency Financial Control Board and reimbursement agencies. Prepares forecasts of fund and cash requirements and requisitions cash from the City Capital Project Fund. Administers an employee time recording and billing system to record time and cost of staff design and construction services for each capital project and vouchers and receives cash from the city Capital Project Fund for staff services provided under interfund agreements. Administers contract change control requirements. Evaluates purchase and contract regulations, procedures and standard contracts and certifies purchase and receipt of all major equipment and permanently identifies the piece and record data in the major equipment inventory control system. Develops procedures with criteria for Prequalification of Contractors as provided in Section 8 of the Corporation Act. Solicits, evaluates and communicates prequalification status to all contractors maintaining lists and individual contractor financial and experience records. Serves as a member of the Architectural and Engineering Selection Board. Supervises and directs the staff assigned to assist in the performance of these major duties and evaluates employee performance. Minimum Qualifications 1. A Masters Degree in Business Administration, Science, Health Care Administration, Engineering or related discipline from an accredited college or university or a license as a Professional Engineer or registration as an Architect; and, 2. Eight years managerial experience in Capital Program or budget work in the construction field including four years experience in budget administration and management of health care facilities; or, 3. A satisfactory equivalent combination of education, training and experience. Department Preferences Preference will be given to qualified candidates with the following knowledge, abilities, education, experience and/or skills: EDUCATION: A Master's degree from an accredited college or university in Hospital Administration, Health Care Planning, Business Administration, Public Administration or an approved related program. LICENSE: A New York State license as a professional engineer or registered architect or a license as a professional engineer or registered architect from a state that has reciprocity with New York State may be substituted for the four years of education and experience. EXPERIENCE: At least 10 years of related experience in design and/or construction management with experience in healthcare clinics; or as a journeyperson in one or more of the skilled building construction trades. Full-time satisfactory experience in planning, design and program development pertaining to meeting health needs, health care planning, design and program implementation, with at least three years of responsible level administrative experience coordinating the planning, design, and construction and commissioning. KNOWLEDGE IN: Thorough knowledge of the principles, practices and methods of Healthcare and Space Management. Long Term Capital Planning Design Management, Construction Management, Budget Management and Time Management Negotiations Regulatory (DOB, FDNY, DOH) Close outs SKILLS: Excellent verbal / written skills. Excellent technical, conceptual, and financial skills. Motivate team efforts to accomplish goals. COMPUTER PROGRAMS/SOFTWARE OPERATED: Microsoft Word and Excel (required) Microsoft Access, MS Project Auto CADD/Revit. Procore/E-builder or similar

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.

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.

& Sons Schweid & Sons is a family-owned and operated premium ground beef company with a proud heritage spanning four generations. We supply top-quality beef to Retail, Foodservice, and National Account customers across the U.S. and are committed to quality, customer service, and innovation in protein manufacturing. Summary: This is a leadership role within the organization that is responsible for a broad range of processes, products, and team members over 2 shifts of production as well as the relationship with FSIS and 3rd party sanitation. Essential Job Functions: Food Safety / Regulatory * Managing implementation of the HACCP Plan, its associated documents and including reassessments * Maintaining records in accordance to the policy / HACCP program * Conduct plant GMP inspections and monitor GMP's for compliance * Responsible for maintaining the company's compliance with FSIS regulations. * Ensure compliance with established policies and procedures such as HACCP, GMP's, SSOP, CAPA, and hold and release of products. * Oversee training program for GMP's, HACCP and Food Defense/Food Fraud. * Respond to non-compliance reports issued by FSIS. * Manage the 3rd party Sanitation program for the facility. Quality / Customer Service * Lead 3rd party audits (SQF / Customer Specific) and Customer tours including CAPA's. * Strive for continuous improvements of products, process, procedures, and reliability. * Maintain data of customer requirements, quality specifications and reporting requirements. * Manage quality training program. * Ensure specification compliance for raw materials and finished products. * Managing implementation of quality programs. * Assist with product development and special projects associated with product development. * Respond to customer complaints with CAPA's / letters as needed. * Establish the raw material and finished product shelf life. Other * Contributing to a Safety Culture Manage FSQA Department (Techs, Sanitations, Supervisors) including exempt and non-exempt labor * Manage the department to meet budget. * Other tasks and projects may be assigned. * 10 - 20% travel required Minimum Requirements: * Red Meat Experience a Must * Bachelor of Science in Food Technology, Food Process Engineering, or related field; MS preferred. * 5 plus years' experience working in the Food Industry in a leadership role. * HACCP Knowledge and Experience * SQF / BRC Knowledge and Experience * Ability to think independently and take responsibility for decisions. What We Offer * The expected compensation for this role is $100,000 - $130,000 per year, depending on experience and qualifications. Final compensation will be discussed during the interview process. * Time Off: PTO, Safe & Sick Time, and Paid Holidays. * Health Benefits: Medical, vision, dental, HRA and voluntary disability benefits. * Financial Benefits: 401(k) + employer match and life insurance. * Location: This is an on-site role located in Carlstadt, NJ. * Environment: Our facility is refrigerated. In this role you will be exposed to < 40 degrees for multiple hours of the day.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH). Essential Functions * Independently conduct audits * Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits * Facilitate Sponsor health authority inspections of global clinical facilities and study sites * Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs * Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies. * May be responsible for direct people management including goal setting, performance management, development, and engagement. Requirements * Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. * 5+ years of experience in GCP auditing. * Substantial experience in inspection management. * Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials. * Demonstrated ability to operate and influence decision-making processes * Effective communication skills * Successful track record of supervising employees and managing cross-cultural differences * Technical and administrative capabilities to independently carry out routine, complex and for-cause audits * Knowledge of data integrity controls and systems quality for clinical area * Strong analytical skills and report writing skills * Experience with GxP systems including computer system validation and associated regulations, recommended. * Ability to Travel (approximately 20%) * Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities. Eisai Salary Transparency Language: The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit *********************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

Quality Manager Industry: Manufacturing / Government Contracts U.S. Citizenship Required / No Dual Citizenship Oversees and manages the Quality Management System and Quality Program to ensure consistent production of products that meet established quality standards. Plans, coordinates, and directs quality initiatives, working both independently and through subordinates to maintain and improve product quality. Responsibilities Overall responsibility for the implementation, training and maintenance of the Company's quality management system. Including the preparation of and revisions of the Quality Management System Manual and Quality Assurance Manual and associated quality procedures. Responsibility for the assignment, selection, indoctrination and training of personnel performing quality related functions. Assuring that the policies of the Manuals are strictly adhered to for all products manufactured and supplied by TMS-CAC. The identification and correction of conditions adverse to quality. Control of procurement documents, including the auditing of suppliers for material and services. Participating or acting as Lead Auditor in Internal and External audits. Participating in Continual Improvement to increase productivity, improve quality processes and reduce scrap. Attending Production and Pre-Manufacturing Meetings as required. Reviewing and approving Supplier procedures and documentation. Manage and coordinate all quality assurance activities with the Quality Control Supervisor, Quality, NDE Level III Manager, MT Doc. Lead, and Quality System Supervisor. Manage customer complaints, conduct root cause analysis, and address quality issues to maintain customer satisfaction. Interfacing with customers, other internal departments, and organizations outside of TMS-CAC. Performing other duties as assigned. Qualifications Must be a U.S. Citizen. Assets: ASME Section III knowledge or experience. Familiarity with quality standards such as ISO 9001, NQA-1, 10CFR50 App. B, etc. ASQC Certified. NDE knowledge. Knowledge of metallic ASTM/ASME Specifications. Knowledge of mechanical test methods of metals. Computer skills: Working knowledge of Microsoft Suite. Language: English (Spanish an asset) Able to read and interpret documents, instructions and procedures. Able to write routine reports and correspondence. Able to speak effectively before groups of customers and employees of TMS-CAC. Skillset: control plan management; process monitoring and improvement; lean manufacturing (process mapping, standard work definition, etc.); root cause analysis and formal corrective action; knowledgeable of ISO 9001 quality systems Other valuable skills: Failure Modes and Effects Analysis; design of experiments; internal auditing; calibration management; job shop manufacturing experience; up-front specification review and contract review; familiarity with inspection methods (traditional dimensional or CMM systems, NDT: penetrant, magnetic particle, or ultrasonic) Education and/or Experience Master's Degree in Science or Engineering or Bachelor's Degree in Science or Engineering with 10 years related experience. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands and fingers to handle or feel and talk or hear. The employee is frequently required to sit. The employee is occasionally required to walk; reach with hands and arms and stoop, kneel, crouch, or crawl. The employee is occasionally required to lift up to 25 pounds. The vision requirements include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus. Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment can vary. Trident Maritime Systems is an EEO/AA employer that offers a comprehensive compensation package and opportunities for growth. As a government contractor, we adhere to regulations including the need for U.S. citizenship for certain positions. Offers of employment are contingent on and not considered finalized until the required background check and drug test has been performed and the results received and have been accessed. About Trident Maritime Systems - Custom Alloy Division Trident Maritime Systems is a global leader in providing innovative solutions for maritime and defense industries. Our Custom Alloy division in High Bridge, NJ, specializes in manufacturing high-quality seamless and welded pipe and tube solutions, as well as custom fabrications for critical applications. We serve government and commercial clients. For government, we work on military and defense contracts requiring precision and reliability. For commercial clients, we provide custom-engineered solutions across various industries. This dual focus allows us to take on diverse, high-pressure projects. Unlike mass production facilities, we create large, custom fittings tailored to specific needs. Our plant features large machines for heavy-duty work in a traditional manufacturing environment. It can be hot, cold, or dirty, but we prioritize safety and provide tools and training to ensure success. Trident Maritime Systems offers a comprehensive benefit package which includes: Cigna medical, dental; VSP vision. Flexible Spending Account & Health Savings Account (with company contributions) 401K - 3% match Paid Time Off 10 Paid Holidays Safety shoe reimbursement, $200 per year Prescription safety glasses program Voluntary Supplemental Insurance Company Paid Life Insurance Voluntary Life Insurance Paid training and development opportunities Employee referral program

Create a future where DNA is no longer destiny. Join Rocket Pharma. Rocket Pharma is a fully integrated, late-stage biotechnology company advancing gene therapies with curative potential for patients with rare and life-threatening diseases. We are a team of creative, compassionate, and driven individuals united by a profound mission of seeking gene therapy cures. Rocket places tremendous value on our people and fosters a collaborative environment where bold ideas thrive and every team member makes a meaningful impact. Our core values guide everything we do: we trust one another, show generosity toward patients, embrace curiosity, and strive to elevate science. Team members receive a competitive total rewards package, including equity participation, 401(k) matching, and excellent health benefits. Position Summary This Quality Control (QC) Laboratory Manager role is a scientific based position that involves reviewing and analyzing test results as well as overseeing daily lab operations. You will be a key team member responsible for keeping QC operations running in an efficient and productive state. This role interacts with the lab technicians, management, EHS, Facilities, and QA to ensure strict adherence to procedures with a continuous improvement mindset. The ideal candidate will be extremely organized, have a strong analytical operations background, and have a strong passion and curiosity for science and gene therapy. Responsibilities Managing Lab Technician(s) overseeing sample management (receipt, storage, distribution, and disposal) and stocking of lab consumables and reagents Scheduling assays through Electronic Scheduling System for QC and preparing all necessary materials and controlled worksheets and protocols/methods for the scientists to execute the assays Supporting Management by performing peer reviews of testing data Supporting Method Performance tracking and trending through data entry, verification, and record archival Establishing and maintaining training curriculum for the lab scientists and supporting scheduling for cross-training of analysts Maintaining control and inventory of critical reagents, Reference Standards, Retains/Reserves, etc. Operations tracking including Assay Results, Invalid Assays, and Equipment cleaning, maintenance, and calibration Tracking on time closure of QC Quality records including Deviations, Invalid Assays, OOS and CAPAs and reporting of Metrics upwards to QC/QA management Support revision of SOPs and forms to improve workflows in QC Overseeing Housekeeping activities of lab areas Verifying Logbooks are reviewed on time Tracking Lab Notebooks lifecycle Working with EHS to improve Safety Culture in QC Qualifications M.S. in Biology, Molecular biology, or Immunology with 4+ years of relevant experience or BS in Biology, Molecular Biology, or Immunology with 6+ years of relevant experience or equivalent experience in the biotechnology industry. Ability to be onsite 5 days per week Deep understanding and experience with working in a GMP environment Experience with dd PCR, ELISA, Flow-cytometry, UPLC and/or cell-based assays Ability to work independently and make decisions Leadership experience and project management skills to support a multi-project environment in small biotech. Physical Requirements: Constantly works in a GMP lab environment with analytical instruments, reagents and cleaning materials Cleaning with biohazard materials and chemical solutions including bleach and Spor-Klenz Constantly wears proper PPE including lab coat, safety glasses and chemical resistant gloves Must be able to remain in a stationary position for 50% of the time Must be able to detect and distinguish primary colors (red, yellow, and blue) and secondary colors (green, orange, and purple) as they appear on process equipment digital displays and computer screens Constantly communicates verbally with people to exchange information, and give and receive instructions Frequently positions self to set-up, operate, clean, and maintain process equipment and handle materials Compensation The expected salary range for this position is $122,000 to $144,000. At Rocket, our compensation philosophy and ranges are built upon data and insights collected from validated world-class providers. We are committed to compensating employees equitably based on several factors, including responsibilities and level of the position, depth and types of the employee's experience, location of the position and availability of similar talent in a competitive market. For U.S.-based candidates, this is an at-will position, and Rocket reserves the right to adjust the range at hire or during the year due to market shifts. In addition to base salary, Rocket offers a competitive total rewards package that may include bonuses (short-term incentives), medical, dental, and vision insurance, life insurance, 401(k) with company match and generous vesting, paid vacation and holidays, global shutdown days between Christmas and New Year's, and a variety of wellness resources and employee support programs. Also, certain positions are eligible for added forms of compensation, such equity awards (long-term incentives). EEO Statement A diverse workforce fosters innovation and strengthens Rocket's business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.

Job SummaryDirect, lead and supervise the development of a total quality environment with an emphasis on unexcelled customer satisfaction and continual quality improvement. Accomplish quality-related objectives using quality meetings, planning, training, statistics, and internal/external audits. Ensure that processes and products are in compliance with the current Quality Management System requirements and applicable regulatory obligations. Serve as the designated authority for regulatory programs (e.g., ODA), maintaining compliance with external agency expectations while aligning with company quality standards.Job Description Key Accountabilities: •Direct and coordinate all aspects of Quality Management, including ISO/AS/TS compliance, quality improvement initiatives (CQIB), and customer satisfaction strategies to support company goals and objectives. •Report on the suitability and effectiveness of the Quality Assurance System while fostering a strong quality culture across all branches through leadership collaboration and communication. •Partner with department managers to establish goals, assess competencies, and guide quality outputs in alignment with corporate Quality Objectives. •Maintain frequent communication with site Quality Assurance Representatives to ensure consistency, effectiveness, and alignment across regions. •Lead and oversee quality assurance functions, including planning, statistical process controls, corrective/preventive action systems (CPAR), customer/vendor claims, trend analysis, and documentation of customer quality requirements. •Direct internal and external audits, provide technical assistance, root cause/corrective action process, manage quality non-conformance and drive employee training and development in quality, regulatory compliance, LEAN, and safety. •Support overall ODA program activities as required, including maintaining Unit Member records, coordinating application reviews and evaluation panels, tracking required FAA training, and assisting with annual evaluations and related correspondence. •Assist in developing, revising, and maintaining ODA quality manuals and procedures in collaboration with ODA representatives and stakeholders, ensuring alignment with FAA policies and identifying process or training impacts from regulatory updates. •Contribute to planning and execution of ODA and FAA audits, including preparing audit materials and reports, coordinating timely closure of corrective actions, and ensuring accurate tracking and reporting of ODA/FAA-required metrics and quarterly submissions. •Provide leadership and direct supervision to quality department teams across multiple functions, ensuring alignment with organizational goals. •Report directly to the Plant Manager and indirectly to Corporate Regulatory/Trade Compliance leadership to drive corporate quality, standardization, and safety initiatives. •Participate, support, and comply with all health, safety, quality, ISO and 6S Initiatives, compliance and Lean initiatives, requirements, and/or trainings. •Ability to access and work in SAP or other Warehouse Management System •Provide leadership and direct supervision to quality department teams across multiple functions, ensuring alignment with organizational goals. •Report directly to the Plant Manager and indirectly to Corporate Regulatory/Trade Compliance leadership to drive corporate quality, standardization, and safety initiatives. •Participate, support, and comply with all health, safety, quality, ISO and 6S Initiatives, compliance and Lean initiatives, requirements, and/or trainings. •Ability to access and work in SAP or other Warehouse Management System The above is intended to describe the general content of and requirement for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements. Meet all other TKMNA employee attributes and competencies Qualifications: Minimum Requirements: This position requires access to export-controlled technical data or technology. Employment is contingent upon obtaining any required export authorization from the appropriate government agency or agencies. When export authorization is necessary, the length of time to obtain the authorization by the government is outside of the Company's control. •Bachelor's degree/ 3+ years management experience/ leadership/team building/training in Quality Assurance/Control. •ODA Certification/industry credential & knowledge of ODA programs, FAA regulations, or aerospace regulatory compliance. •3+ years relevant experience working as a supplier ODA Focal or Unit Member in an aerospace or any equivalent industry. •Experience in TQM, ISO/QS 9000 ISO Assessor Certification, SPC. •Demonstrated proficiency in Microsoft Word, Excel, and PowerPoint, with strong verbal, written, and interpersonal communication skills. •Demonstrates dedication to delivering high-quality customer service while being positive, detail-oriented, organized, team-oriented, and a proactive problem-solver capable of multitasking and prioritizing in a fast-paced, deadline-driven environment. Preferred Requirements: •ASQ certification •ISO Lead Assessor Certification •5 years plus Quality Assurance/Control •3+ years of experience as an FAA ODA Unit Member or Supplier ODA Focal, with working knowledge of FAA rules, regulations, ODA programs, and aerospace regulatory compliance (or equivalent industry experience). •Training in strategic planning and motivation Benefits Overview We offer competitive company benefits to eligible positions, such as : Medical, Dental, Vision Insurance Life Insurance and Disability Voluntary Wellness Programs 401(k) and RRSP programs with Company Match Paid Vacation and Holidays Tuition Reimbursement And more! Benefits may vary based on job, country, union role, and/or company segment. Please work with your recruiter or tk representative for applicable benefits information. Disclaimer This is to notify the general public that some individuals/entities are using the thyssenkrupp (“TK”) name, trademark, domain name, and logo without authorization. They are posing as employees, representatives, or agents of TK and its associated/group companies. These individuals/entities are fraudulently offering jobs online through texts, websites, telephone calls, emails, or by issuing fake offer letters. They are also soliciting jobseekers to deposit money in certain bank accounts or providing jobseekers with fraudulent checks to obtain banking information. TK does not ask, solicit, or accept any monies in any form from candidates, job applicants, or potential jobseekers, who have applied to or wish to apply to TK, whether online or otherwise as a pre-employment requirement. TK bears no responsibility for money being deposited/withdrawn therefrom in response to such fake offers. TK does not: 1. Send job offers from free email services like Gmail, Rediffmail, Yahoo mail, etc.; 2. Request payment of any kind from prospective jobseekers or candidates for employment; 3. Authorize anyone to collect money or agree to any monetary arrangement in return for a job at TK; 4. Send checks to job seekers; or 5. Make job offers through third parties. In the event TK uses professional recruitment services through a third party, offers are always made directly by TK and not by any third parties. PLEASE NOTE: 1. TK strongly recommends that potential jobseekers do not respond to such fake solicitations, in any manner; 2. TK will not be responsible to anyone acting on an employment offer that is not directly made by TK; 3. Anyone making an employment offer in return for money is not authorized by TK; and 4. TK reserves the right to take legal action, including criminal action, against such individuals/entities. TK follows a formal recruitment process through its own HR department and applications are evaluated by its HR department through pre-defined processes. 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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 Description QUALITY MANAGER to 130k MANUFACTURING ISO 9001 Handson Leader Aerospace industry must have enough work/life experience 5-7 years management experience 5-7 years machining experience Career progression in the quality field ISO 9001 - 14001 - 45001 ITAR Environment & Safety experience INDUSTRIAL MANUFACTURING DOD MANUFACTURING ITAR A PLUS Westchester County NY . Long established, financially stable manufacturer. APPLICANT REQUIREMENTS: MUST HAVE... 5-7 years of management experience, ideally in a manufacturing or job shop setting 5-7 years of machining experience with a solid understanding of dimensional tools (e.g. calipers, micrometers, Sunnen gauges, optical comparator, CMM machines) Demonstrated career progression in the quality field ISO 9001:2015 and AS9100 experience required; certifications in ISO 14001, ISO 45001, or similar a plus Experience with ITAR compliance Exposure to or direct involvement in environmental and safety standards (EHS) Excellent blueprint reading and interpretation skills Familiarity with Pre-Production Approval Process (PPAP) and Failure Mode Effects Analysis (FMEA) Root Cause Analysis and Product Control Plans/Inspection Methods Strong grasp of statistical process improvement techniques, including Six Sigma (Green or Black Belt preferred) Excellent math, computer, and communication skills High energy, highly organized, and detail-oriented Bachelor's degree preferred; however, equivalent work/life experience will be strongly considered DUTIES and RESPONSIBILITIES: Serve as the Quality System Management Representative, maintaining and auditing the company-wide ISO 9001 Quality Management System Manage the daily operations of the Quality Department in an ISO 9001 / AS9100 environment Oversee physical inspections of incoming materials, in-process production, and final product before shipment Maintain and control quality documentation including the Quality Manual, SOPs, and Work Instructions Lead and participate in internal audits, address nonconformances, and develop corrective action plans Collaborate with cross-functional teams to monitor and enhance product quality Prepare reports and support quarterly executive management reviews on quality metrics and audit outcomes Drive continuous improvement initiatives and enforce company quality standards Support environmental and workplace safety practices in coordination with EHS requirements A comprehensive benefits package which includes Medical, vision, dental, life insurance Sick days, holidays, vacation 401(k) Plan

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.

**General Description:** Supervises staff and executes QC Biochemistry laboratory activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations, applicable International Regulations, BeOne processes and procedures. Establishes and implements QC Biochemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day to day operations of the Biochemistry laboratory. **Essential Functions of the job:** + Lead the QC Biochemistry GMP laboratory through late phase activities. + Oversee QC Biochemistry laboratory related quality systems to ensure conformance with regulations and BeOne Global quality standards. + Supervise a highly efficient QC Biochemistry team. Identify and develop key talents. + Manage QC Biochemistry laboratory routine operations, including but not limited to validation, SOP revisions, specification updates, testing records, personnel training and, scheduling, etc. + Execute laboratory bench work for analytical methods such as Potency assays, Binding ELISA, Cell Culture, Residual Host Cell Protein(HCP), Residual DNA as required. + Ensure Biochemistry laboratory compliance with Environmental Health and Safety (EHS) standards. + Ensure timely completion of testing (e.g., in-process, DS release, DP release, and stability testing) to ensure timely generation and reporting of test results In support of manufacturing operations. + Ensure appropriate investigation of OOS events, discrepancies, lab errors, and equipment failures. + Implementation of effective corrective actions and preventive actions (CAPAs). + Participate in internal and external GMP audits where possible. + Manage QC Biochemistry method transfers and method validation activities, including transfer/validation strategy and approval of protocols and reports. + Ensure that the QC Biochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives. + Manage, motivate, coach and mentor direct reports. + Undertake any other duties as required. **Core** **Competencies** **, Knowledge, and Skill Requirements:** + Scientific degree (ideally in Biochemistry, molecular biology, biotechnology or related). + Minimum of 5-7 years working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required. + Working knowledge and experience with Biochemistry analytical methods such as Potency assays, Binding ELISA, Cell Culture, Residual Host Cell Protein(HCP), Residual DNA as well as instruments such Incubators, Biosafety Cabinets, Plate Washers, and Microplate Readers, etc. + Knowledgeable with USP/EP and cGMP/EU GMP regulations. + Direct experience in a GMP quality control lab is a must. + Familiar with instrument and equipment validation. + Expert knowledge of quality control principles, practices, and standards for the biopharmaceutical industry. + Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level. + Credible and confident communicator (written and verbal) at all levels. + Strong analytical and problem-solving ability. + Excellent project management skills. + Hands-on approach, with a 'can do' attitude. + Ability to prioritize, demonstrating good time management skills. + Excellent attention to detail, with the ability to work accurately in a busy and demanding environment. + Self-motivated, with the ability to work proactively using own initiative. + Committed to learning and development. **Supervisory Responsibilities:** + Supervise a highly efficient QC Biochemistry team. Identify and develop key talents. + Manage QC Biochemistry laboratory routine operations, including but not limited to validation, SOP revisions, specification updates, testing records, personnel training and scheduling, etc. + Manage QC Biochemistry method transfers and method validation activities, including transfer/validation strategy and approval of protocols and reports. + Ensure that the QC Biochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives. + Manage, motivate, coach and mentor direct reports. **Computer Skills:** + Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint). + Ability to work on a computer for extended periods of time. **Education Required:** Bachelor's Degree required in Chemistry, Biochemistry, or Biotechnology related scientific discipline and 5-7 years of working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology, pharmaceutical company are required. Master's degree in Chemistry, Biochemistry, or Biotechnology related scientific discipline and 4-5 years of working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology, pharmaceutical company are preferred. **Travel:** + Must be willing to travel approximately 10%. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Quality Assurance Manager The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of corporate Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs.The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation. The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve the requisite business needs, while providing ongoing support to Manufacturing processes. Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements. Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues. Establish and maintain policy for documentation of all products and perform internal documentation audits. Author and review relevant SOPs, validation and other documents. Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports. Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review. Control Master Batch Records, distribution and label verification. Perform line clearance activities as required. Assign and maintain product lot numbers as applicable. Ensure materials management nonconformance disposition and release activity as applicable. Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions. Provide Quality Assurance related support to various departments. Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies. Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks. Provide support to manufacturing for investigations of deviations, validations, and development of specifications Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements. Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted. Perform employee training on QSR and ISO requirements and company quality systems Perform document control activities as assigned. Mentor/train/develop and manage Quality Assurance team. Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality Agreements REQUIREMENTS BS Degree in biological sciences or equivalent. Minimum 5-10 years related experience in the pharmaceutical or biologics industry. Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs). Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc. Sound knowledge of aseptic processing and supporting technologies. Analytical and technical troubleshooting skills are a plus. Proficient with Microsoft Office Suite. Excellent organizational skills and attention to detail. Good verbal and written communication skills. Strong team-oriented interpersonal skills are essential. Travel may be required Strong business acumen Experience with Visio, Microsoft Project and Excel) Ability to think strategically and tactically (detail-oriented) Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment Analytical and problem-solving skills Strong written and oral communication skills Meeting management/facilitation skills/teamwork Ability to multi-task is essential Flexible and able to adapt to company growth and evolving responsibilities Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

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.

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

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.