Quality manager jobs in Elizabeth, NJ

Under the direction of the Vice President and Chief Quality Officer, the Director of Quality Improvement is responsible for developing and implementing the organization's Performance Improvement plan and priorities consistent with regulatory standards and evidence based best practices. As a member of the leadership team, serves as a role model and leader to colleagues and staff throughout the organization. Thoughtfully develops and implements initiatives to achieve improvements consistent with hospital strategic priorities. Promotes a culture that is positive, that values individual strengths, and is committed to optimal patient care, and compliance with regulatory standards. This position is responsible for direct supervision of the Quality Analyst and Quality Improvement Specialist and serves as the Stroke Coordinator. Key responsibilities include: • Strategic focus on improving quality. Responsible for goal setting and achievement using SJMC established Performance Improvement methodology and analytic tools. Defines measurable and actionable metrics and ongoing monitors to sustain performance. • Identifies and drives analytic needs for improvement projects/initiatives. Supports leaders in development of problem charter and selection of the best tools for data analysis. Mastery of basic statistical concepts, tools and techniques and working knowledge of improvement tools and techniques. Teaches/mentors others on basic topics and able to assist others with advanced topics. • Serves as Stroke Coordinator and supports the Stroke Program including defining and developing structure, process and outcome measures, policies, accreditation and facilitating and actively developing initiatives to meet and exceed evidence-based care metrics for stroke patients. • Lead and/or facilitate complex multidisciplinary improvement teams as needed to achieve quality and performance improvement goals. • Responsible for oversight of data collection, measurement, and data analysis for organizational, federal and state quality metrics. • Coordinate mortality, patient complaint, and outcome reviews. • Serve as a regulatory resource regarding state and federal regulations and standards, including but not limited to CMS, TJC, and NYS. • Create and present data needed for evaluation and appropriate action by committees, leadership, and quality improvement teams. • Represents the organization within and external to the community when required. • Assist in improving patient experience through analysis of data and implementation of initiatives to improve performance. Requirements: • Bachelor's Degree or commensurate experience required. • Registered Nurse in New York State required • Master's Degree in Healthcare specialty preferred • Current certification as CPHQ strongly preferred. Certification required within 3 years of hire date. • Previous managerial experience preferred. • Competence in Microsoft office products including PowerPoint and Microsoft Excel. • Familiarity with health care clinical operations and processes in an acute care hospital setting. • Familiarity with regulatory requirements as related to hospital setting. Other Requirements: • The employee must regularly lift, carry or push/pull less than 10 pounds, frequently lift, carry or push/pull less than 10 pounds, and occasionally lift, carry or push/pull up to 10 pounds. • While performing the duties of this Job, the employee is regularly required to perform activities that require fine motor skills. The employee is frequently required to do repetitive motion, hear, reach, sit, and speak. The employee is occasionally required to walk. • Specific vision abilities required by this job include color vision, far vision, and near vision. • The noise level in the work environment is usually quiet. Salary: $170K-$180K Saint Joseph's Medical Center is an equal opportunity employer.

Associate Director, Quality Management will collaborate with clinical and administrative staff in the development, implementation, and evaluation of quality improvement initiatives, regulatory compliance programs, and performance metrics across clinical and administrative departments. A typical day in the life: Analyzes quality measures data for accuracy and applicability to performance improvement work for both NYC H+H Jacobi and North Central Bronx. Provides project management for and collaborates on performance improvement projects with clinical and administrative teams. Serves as faculty or advisor in hospital quality improvement capacity-building programs. Assists or manages data submission to CMS, Joint Commission, Department of Health, and various quality programs. Performs ad hoc or special project data abstraction, entry, and analysis to support the Quality Assurance Program. Provides visual aids and graphical representations of data as well as recommendations and support to help clinical and other departments improve care. Demonstrates strong communication, documentation, organizing, and planning skills to ensure strong leadership of multiple accounts concurrently. Pivots to the evolving responsibilities/needs of the Quality department. Reviews Patient Files for any quality-of-care concerns or documentation incongruencies and follows up with clinical areas for appropriate remediation. Makes improvements in the operations of the department, provides recommendations and implements approved changes, including revising procedures or devising new forms or methods to improve efficiency of workflow. Works collaboratively and supportively with the Risk, Regulatory, Patient Safety, and Infection Prevention departments. Qualification Requirements: Baccalaureate Degree in Public Administration, Public Health or Health Care Specialization; AND, 4 years of increasingly responsible experience in hospital administration, with particular emphasis on development and evaluation of health care delivery services; OR Master's Degree in Public Administration, Public Health or Health Care Specialization; AND, 3 years of increasingly responsible experience in hospital administration, with particular emphasis on development and evaluation of health care delivery services. Preferred: Nursing BA/BS or other clinical degree with previous clinical experience. Experience in Quality, Performance Improvement, data analytics, hospital operations, and informatics. Proficiency in Microsoft Office Suite including Excel, Visio, and Access, Epic EHR, and electronic registries. Experience in state and national quality registries including Centers for Medicare/Medicaid Services, The Joint Commission, and Get with the Guidelines Stroke/HF and measures. Nationally recognized quality/safety certification such as CPHQ and/or CPPS preferred. About NYC Health + Hospitals NYC Health + Hospitals/Jacobi and NYC Health + Hospitals/North Central Bronx (NCB) are integral members of the New York City Health + Hospitals system, dedicated to delivering high-quality, compassionate care to diverse communities across the region. Jacobi, a 457-bed teaching hospital affiliated with the Albert Einstein College of Medicine, is renowned for its Level 1 Trauma Center, Burn Center, regional Stroke Center, Surgical ICU, and specialized services including the region's only multi-person hyperbaric chamber. Complementing its inpatient care, Jacobi's state-of-the-art Ambulatory Care Pavilion supports a modern outpatient experience. Additionally, North Central Bronx, a 215-bed community hospital, specializes in women's and children's health, behavioral health, and community-based outpatient care, safely welcoming more than 800 babies annually through its Labor and Delivery service. Together, these facilities embody the NYC Health + Hospitals mission to provide exceptional care without exception. Every employee takes a person-centered approach that exemplifies the ICARE values (Integrity, Compassion, Accountability, Respect, and Excellence) through empathic communication and partnerships between all persons. Benefits NYC Health and Hospitals offers a competitive benefits package that includes: Comprehensive Health Benefits for employees hired to work 20+ hrs. per week Retirement Savings and Pension Plans Paid Holidays and Vacation in accordance with employees' Collectively bargained contracts Loan Forgiveness Programs for eligible employees College tuition discounts and professional development opportunities College Savings Program Union Benefits for eligible titles Multiple employee discounts programs Commuter Benefits Programs

Job Title: Sr Quality Specialist - Cell Therapy Mfg./Pharma Duration: 12 Months Pay Rate: Hourly on W2 ONLY - NO C2C 50% onsite required Work Schedule: Mon-Fri(normal business hours) Position Summary: This position is intended to increase compliance with data quality related activities associated with the addition of new fields in SQM and initial migration of data. In addition, ensure supplier records and associated record relationships are complete and accurate. Duties/Responsibilities The position holder is responsible and accountable for the tasks given below (non-exhaustive list): Request supplier objects and complete SQM records for vendors and materials supporting Cell Therapy manufacturing. Create and manage supplier-related change controls associated with supplier and material qualification, data governance and quality type changes, as needed. Evaluate Quality Agreements and audit documentation to ensure proper linkages to the appropriate supplier records within the SQM system and correct gaps/inaccuracies. Cleanse metadata in source documents (BMSDocs) for supplier related records (materials and service providers). Work with stakeholder groups to identify and populate teams, and the lead oversight groups for each GMP/GDP supplier object/profile in SQM to ensure accountability and compliance. Complete transition of material qualifications from heritage forms to current forms. Complete materials qualification transactions in SQM Module. Reporting Relationship Role is an individual contributor reporting to the project lead. Qualifications: Required Bachelor's degree in science, or a related field. 5+ years of experience in a GMP pharmaceutical, biopharmaceutical, or Advanced Therapeutic Modality Products (ATMP) environment including previous QA experience e.g., QA compliance role, Supplier Quality oversight. 2+ yrs experience with supplier management & oversight, material qualification, governance frameworks, and performance metrics. 3+yrs knowledge and experience with core quality processes - including change control, deviations/OOS, CAPA management, investigations. Thorough knowledge of cGMP in the pharma/Biotech industry as well as FDA, EU, and JP regulatory requirements, ICH guidelines. Knowledge of cell therapy manufacturing processes and testing is a plus. Skilled in planning and organizing, building relationships, innovation management and resource allocation. Ability to make independent and objective decisions and to work under minimal supervision with cross functional teams and partners worldwide. Team spirit. Action-oriented and customer-focused. Negotiation and persuasion skills. Good knowledge of common office software. Good verbal and written communication skills in English. Travel- 5% required to other NJ locations nearby

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.

We are currently seeking an experienced Food Safety, Quality, & Regulatory (FSQR) Director with DAIRY experience to lead the Quality Assurance Department for this growing Consumer Goods Company. This position will set the Food Safety standards for the organization and will be responsible for making sure those standards are met. This role is expected to be the leader and subject matter on all aspects of North American FSQR within the organization. Responsibilities Lead all FSQR initiatives at the corporate and domestic manufacturing locations Help domestic sites manage their Food Safety Programs. Examples include Foreign Supplier Verification Program, Food Safety Plans, HACCP Plans, SQF Programs, Kosher & Halal Programs, and USDA & FDA Registrations Be the North American FSQR subject matter expert for our international partners Lead, guide, and mentor manufacturing site Quality Assurance Managers Assist manufacturing sites in preparation and execution of all external audits (SQF, Regulatory, Customer, etc.) Communicate and work with domestic and international customers to ensure all FSQR expectations are met and resolve any issues Communicate and work with domestic and international sites to ensure FSQR compliance and to help investigate and resolve any non-conformances Act as the Corporate FSQR representative on all domestic cross-functional teams, projects, and initiatives Act as the North American FSQR representative on select international cross-functional teams, projects and initiatives Domestic and some International Travel expected: 30-40% Minimum Qualifications, Education and Experience: Bachelor's degree in food science, Dairy Science, Animal Science, Biology, or related field 5 years of progressive Food Safety, Quality Assurance, and/or Regulatory Affairs experience in a food or beverage industry Thorough understanding of FSMA and GFSI requirements at the Corporate and Manufacturing Site Levels Certifications: PCQI, HACCP, GFSI Practitioner (SQF and BRC preferred) Knowledge, Skills, & Abilities: Previous experience in a dairy product manufacturing plant Experience with Canadian and Mexican food safety requirements Experience with Kosher and Halal program management Experience with food import and export requirements/certifications Skilled in the development and use of Excel Knowledge of TraceGains or other similar Food Safety software Certifications: Internal Auditor, FSVP, Lean Six Sigma

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

Job Title: Project Quality Engineer Shift: 1st Shift (Monday - Friday) Pay Rate: Up to $75000-$95,000 annually (commensurate with experience) Type: Direct Hire Reports To: QA Manager Dept.: Quality Assurance Job Description The Project Quality Engineer supports the Quality Assurance Manager in overseeing the Quality Assurance program for assigned rail car manufacturing projects. This role ensures compliance with contract requirements, technical specifications, and industry standards across production, acceptance, warranty, and modification phases. Responsibilities include creating Master Test and Inspection Plans, First Article Inspection schedules, Project Quality Plans, and audit procedures. The Project Quality Engineer coordinates closely with customers, vendors, and internal Kawasaki divisions to align project requirements, resolve quality issues, and support continuous improvement initiatives. This position also monitors documentation, leads corrective action activities, conducts contract reviews, and provides weekly and monthly quality reports. The engineer will serve as a primary Quality liaison between internal teams, subcontractors, and customer Resident Inspectors, ensuring timely communication, follow-up, and delivery of all quality-related commitments. Candidate Fit Summary This candidate is an excellent fit for organizations in the rail, aerospace, transportation, and heavy manufacturing sectors where strict compliance, technical quality standards, and contractual requirements are essential. They bring strong experience supporting complex production programs, managing supplier and customer interfaces, and developing detailed quality documentation. Skilled in FAI, FMEA, audits, and ISO 9001 processes, they excel in environments requiring strict quality controls, cross-functional coordination, and schedule accountability. Their ability to lead inspections, manage customer quality requirements, and drive corrective actions makes them a strong match for production-focused, project-driven engineering organizations. Essential Functions Implement and maintain QA programs for assigned contracts. Develop Master Test and Inspection Plans, Project Quality Plans, FAI schedules, and audit procedures. Attend project meetings and provide detailed quality status updates and reports. Analyze quality issues, identify root causes, and drive corrective actions. Coordinate with customers, suppliers, and internal teams across production and warranty phases. Manage project quality schedules and interface with Resident Inspectors. Ensure compliance with customer specifications, contract terms, and Kawasaki quality standards. Review and approve subcontractor/supplier documentation (PSI, FAI, audits, drawings, field reports). Monitor and report deviations, implement process improvements, and update procedures. Support Configuration Management planning, execution, and product delivery. Assist with subcontractor activity quality review and documentation. Travel domestically/internationally up to 30% to support project quality functions. Job Specifications Bachelor's Degree in Engineering (Master's preferred). Minimum five (5) years' experience in rail, aerospace, transportation, or heavy manufacturing. Knowledge of FAI, FMEA, ISO 9001, and source inspection processes. Strong communication, analytical, reporting, and computer skills. Ability to plan, coordinate, and manage workloads across multiple concurrent projects. Capable of working in both office and field/manufacturing environments. Work Environment Office and manufacturing floor settings. Frequent interaction with engineering, production, and customer teams. PPE required in production areas; must adhere to all safety protocols. Candidate Fit This candidate is a strong fit for Project Quality Engineering roles in complex manufacturing environments like rail, aerospace, automotive, and heavy industrial production. They have demonstrated capability in quality planning, regulatory compliance, supplier oversight, and customer interface management. With experience leading FAIs, audits, and corrective actions while supporting production schedules, they excel in driving continuous improvement, ensuring contract compliance, and maintaining high standards of safety, product quality, and documentation integrity. Their structured approach, technical acumen, and ability to manage project-based workloads make them a key contributor to high-complexity engineering programs. Company Overview Founded in 2010, Top Prospect Group was created with a focus on matching high-quality candidates with top-tier clients while fostering an environment where success is shared by all. In 2023, the company was acquired by HW Staffing Solutions, expanding its service offerings to include technology, engineering, and professional services. Qualified candidates are encouraged to apply immediately! Please include a clean copy of your resume, salary expectations, and availability with your application.

Role: QA Engineer App Sr Advanced Tech hybrid 3 days onsite. Duration: Contract Mandatory Skills & Qualifications 10+ years of relevant client-facing experience in QA/testing roles (excluding training periods) Minimum 5 years of on-site client experience in similar technology and domain Educational Requirement: Bachelor's degree in Technology (Master's preferred) Strong hands-on experience with the MERN Stack (MongoDB, Express, React, Node.js) Proficiency in programming/scripting: Java and JavaScript Extensive experience with modern automation tools such as: Selenium WebDriver Cypress or other industry-standard automation frameworks Strong understanding of QA methodologies, SDLC, STLC, Agile/Scrum processes Experience building reusable automation frameworks (UI and/or API) Experience in Performance Testing tools (e.g., JMeter, Locust) - preferred for Group B

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 :195,000-256,000Under 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

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 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

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.

Our client is a fast-growing personal care and cosmetics manufacturer known for innovation, high standards of product excellence, and a passionate consumer base. They are looking to add a Quality Control (QC) Manager to their team. Salary/Hourly Rate: $90k - $115k Annually Position Overview: The Quality Control (QC) Manager will lead product-focused quality control operations to ensure that all finished goods meet established specifications, regulatory requirements, and internal quality standards. This role is integral in overseeing product release, managing QC laboratory functions, supporting investigations, and driving continuous improvement initiatives. The Quality Control (QC) Manager will supervise a team of 2-3 specialists and serve as a key partner to the Quality Director in strengthening quality systems, documentation, and operational readiness. Expected travel: 30% to contract manufacturers nationwide Responsibilities of the Quality Control (QC) Manager: * Oversee the complete product release process, including incoming inspection, analytical testing, disposition, and management of nonconformances. * Review and approve deviations, investigations, and CAPA documentation to ensure thorough root-cause analysis and effective corrective actions. * Collaborate cross-functionally to support new formulation launches and ensure quality requirements, inspection criteria, and testing protocols are clearly defined and implemented. * Manage the QC laboratory, including equipment oversight, instrument calibration, cleanliness, and adherence to safety practices. * Supervise the retention program and maintain product master standards. * Evaluate consumer complaint samples and support trend analysis. * Administer and enhance the Quality Management System (QMS) for documents, SOPs, CAPAs, audit records, and inspections. * Develop and deliver training on cGMP, quality systems, and technical processes. * Provide leadership, coaching, and performance feedback to QC Specialists. * Monitor, analyze, and report on quality KPIs to drive improvements across QC operations. Required Experience/Skills for the Quality Control (QC) Manager: * 5+ years of QC or quality-related experience in personal care, cosmetics, or fragrance manufacturing (required). * Prior supervisory experience. Ability to lead and develop laboratory personnel. * Strong background in nonconformance management, analytical testing, and release processes. * Experience operating in cGMP/ISO 22716 environments. Education Requirements: * Bachelor's degree in a scientific or engineering discipline (or equivalent experience) is required. Benefits: * Comprehensive medical, dental, and vision (including HSA with employer contribution). * PTO. * Paid holidays. * 401(K) and many more!

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. Please visit our official careers website at ******************************** to view authentic job openings at TK. If you receive any unauthorized, suspicious, or fraudulent offers or interview calls, please email us at **********************************************. We shall not accept any liability towards the representation made in any fraudulent communication or its consequences, and such fraudulent communication shall not be treated as any kind of offer or representation by TK or its group companies and affiliates.

We are working with a globally produced brand that brings premium specialty food to US consumers. Their diverse portfolio fits any table, in or out of the home. Their generations of craft, expertise, and passion enrich every meal. This company is seeking a Senior Quality Control Manager to supervise the QC and Sanitation departments. Reporting in to the QC Director, this individual will ensure HACCP, PCQI, SQF, and GMP standards are met. Location: Edison, NJ Job Responsibilities: Directly supervise a team of QC Technicians and Sanitation Team to ensure they understand and successfully perform job duties associated with the FSQA role. Train QC technicians to complete all required documentation relating to quality checks, sanitation, product holds and release, and any other function to maintain and improve quality and integrity of the products. Verify that all CCP's and quality checks are correctly carried out and completed. Completion of the all-around day finished product inspection to ensure the fitness of next-day shipping. Ensure all testing equipment is in good operating condition and calibrated according to the written procedure. Carry out environmental swabbing, ensure Swabs and finished product samples are sent to the lab. Helps QC Director to implement SQF requirements, company's GMP, Quality, and Food Safety policies and procedures. Able to communicate and provide guidelines (Hazzard Analysis and Risk-Based Preventive Controls) for any product and procedures to the Quality Team as well as Production Supervisor/Line Leads in the absence of the QC Director. Ability to perform Customer Complaints investigations and conduct Rot Cause Analysis. Help Director for updating and maintaining SQF compliance documentation for the 1 st and 2 nd shift. Work with Production Manager and QC Director for completing monthly food safety inspections, corrective actions, and risk assessments. Conduct internal GMP and Facility audits and monitor Sanitation activity to achieve objectives while fostering s a safe working environment. Keep inventory of all PPE and Sanitation supplies and communicate to QC Director for re-order as necessary. Required Skills/Qualifications: Bachelor's degree in Food Science or associate with a minimum of three years of Food Manufacturing Quality Assurance experience in place of degree required. Knowledge of the industry's best practices of GMP HACCP Certified PCQI Certified A bilingual (Spanish) communication skill is highly preferred to manage and train staff to maintain the high-quality standards in the facility. Previous dairy industry experience is a big plus. Ability to stand/walk for a minimum of 6 hours during shift. Ability to work occasional weekends and flexible schedules as business needs demand. Ability to work with or around a cold environment and confined spaces like spiral, freezer, etc. Must be able to wear/utilize personal protective equipment when and where needed.

Quality Control Manager, Training & ComplianceAllendale, NJ The Quality Control (QC) Manager, Training and Compliance will manage the training and compliance programs across the analytical and microbiological laboratories. This role will ensure that there is a robust training program for the analytical and microbiological laboratories. In addition, this role will manage compliance activities within the laboratory such as deviations, CAPAs, document review, etc. The QC Manager will also be responsible for the management of external laboratories to include development of Quality Agreements, review of test results and resolution of any issues. Develop and maintain training program within Quality Control which includes, onboarding and continuous training Manage deviations, CAPAs, change controls and document review to ensure compliance Ensure OOS investigations are completed adequately. Manage external laboratories to include development of Quality Agreements, monitoring of samples and test results, reviewing deviations/OOS investigations, resolving issues and developing a scorecard to monitor the quality performance of the external laboratories Identify resources needed for training and compliance and build team accordingly Ensure compliance with applicable cGMP regulations while ensuring compliance with company and client requirements. Monitor effectiveness of CAPAs, change control activities, and audit observation closure. Directly supervises 1-4 employees within the Quality Control department(s).Directly supervised the following roles - Technical Trainers, Compliance Investigators Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. REQUIREMENTS BA/BS/MS in a science or relevant field required Prior cGMP experience required Prior QC laboratory experience in a cGMP environment a must 3-5 years' experience in the pharmaceutical, biologics ore related industry Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff with a minimum of five (5) years in a management position Sound understanding of cGMPs Experience in laboratory training and compliance External laboratory management experience Strong knowledge of testing methodologies, philosophies, method validation and method transfers. Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner Experience with laboratory training programs Knowledge of GMP requirements Excellent organizational and leadership skills Outstanding analytical problem-solving abilities While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. 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.

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.