Director of Quality Improvement
Quality assurance manager job in Yonkers, NY
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.
Quality Assurance Manager
Quality assurance manager job in Jersey City, NJ
About the Company:
Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. Celltrion Healthcare, which suggested a new growth model in the Korean biopharmaceutical industry through biosimilars, is now advancing to new challenges to become a global pharmaceutical provider. Just as it has overcome many obstacles in the past, Celltrion Healthcare will successfully pave the path for global direct selling, which has never been achieved yet by Korean biopharmaceutical companies. As it continues to surpass its current success, Celltrion Healthcare will take a leap forward to become a leading global biopharmaceutical company.
Celltrion Healthcare provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world.
POSITION SUMMARY
Responsible for management of quality assurance department of Celltrion USA. Operate and maintain a quality system for the distribution of biopharmaceutical products, ensuring full compliance with Good Distribution Practice (GDP), including 21 CFR Part 210/211 or 21 CFR Part 820
KEY ROLES AND RESPONSIBILITIES
Make decisions related to Quality issues in support of company's business and operational objectives
Report directly to the Quality Assurance Director routinely to ensure that Quality Assurance Director is adequately and timely informed of the status of the quality system
Review and approve all quality activities, including review and approval of all quality system SOPs
Review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the applicable requirements of the Quality System Regulation (QSR) as set forth under 21 C.F.R. Part 820 and CELLTRION USA's established quality policies, procedures, and objectives
Ensure quality system procedures and instructions are established and maintained
Provide quality compliance guidance and training to all staff on QMS SOPs and its applicable provisions
Lead initiatives for the continuous improvement of the quality system and ensure that measurable results are achieved
Stay current on industry best practices, trends, and relevant regulatory intelligence
Provide regular communication across all divisions, including the marketing and sales organizations, regarding Quality System management for Good Distribution Practice(GDP)
Manage routine quality meetings with staff and Celltrion's Corporate QA team
Collaborate with Celltrion's Corporate QA team on the management of quality systems at Celltrion USA
Conduct on-site or remote audits of Third-Party Logistics(3PL) sites and other services providers.
WORK EXPERIENCE
10+ years' experience in quality assurance (QA) at a pharmaceutical company
Prefer to have 3-5 years in a manager role in a biotechnology/LifeScience industry or specifically in the Good Distribution Practice (GDP) of biopharmaceutical products.
Strong knowledge of Quality Management Systems(QMS) for the Good Distribution Practice (GDP) of biopharmaceutical products
SKILLS AND SPECIFICATIONS
Excellent oral and written communication skills
Recognized as a great listener, learner, and strategic contributor
Proven management skills including communicating with executive management
Experienced in the management of a regulated medical products company
EDUCATION
Bachelor's degree or above.
CORE COMPETENCIES
Ethics and Values
Regulatory Knowledge
Conflict Management
Problem Solving
Personal Learning
Action Oriented
Timely Decision Making
Organizational Agility
Drive for Results
Celltrion USA is an equal opportunity employer. It is our policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
#LI-DD
Associate Director, Quality Management
Quality assurance manager job in New York, NY
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
QA Validation Specialist
Quality assurance manager job in Hauppauge, NY
The QA Validation Specialist is responsible for performing and overseeing cGMP-compliant validation and qualification activities related to equipment, facilities, and utilities within pharmaceutical manufacturing and drug product development. This role ensures that all systems are properly commissioned, qualified, and maintained in accordance with regulatory standards and internal procedures.
Responsibilities:
Plan and execute equipment, facility, and utility qualification in compliance with cGMP regulations.
Coordinate calibration and preventative maintenance schedules with internal teams and external contractors.
Prepare and review validation documentation, including protocols, reports, SOPs, URS/FRS/DDS, FATs/SATs, and commissioning forms.
Maintain validation master plans, environmental monitoring reports, and ensure documentation is current and audit-ready.
Evaluate validation projects, develop test plans, and collect/analyze data for reporting and approval.
Conduct gap assessments and remediation for legacy validation documentation.
Support audits and inspections, including responses to FDA or client validation-related inquiries.
Participate in deviation investigations, change control processes, and continuous compliance improvement efforts.
Qualifications:
Bachelor's degree in a scientific discipline (e.g., biology, chemistry, pharmacy) or related field.
1-2 years of experience in a pharmaceutical manufacturing environment (DPI, MDI, oral solid, or injectables preferred).
Proficiency in Microsoft Office and quality/compliance software tools.
Solid understanding of cGMP requirements, validation lifecycle, and regulatory compliance standards.
Strong communication skills and the ability to work independently or as part of a cross-functional team.
Quality Control Manager
Quality assurance manager job in Harrington Park, NJ
Our client - a pharmaceutical company, needs a Manager of Quality Control at their plant in northern NJ.
Job Posting # 2695R
Job Title: QC Manager - Pharma Manufacturing
Compensation: Salary range $125K - $135K + Annual Bonus Eligible
Relocation: YES - Client offers relo assistance
Benefits: Full package for medical, dental, vision, etc.
Group Info:
The QC Manager will manage Technical QC lab people
Job Summary:
The Quality Control Manager is responsible for managing all daily activities of a QC team.
The primary responsibility is to ensure that Quality Control personnel perform all testing accurately and as specified by the appropriate quality documentation while maintaining the lab instrumentation in accordance with approved procedures
Candidate Must Have:
Bachelors of Science in Chemistry or related degree
Min. 10 years of QA/QC experience
Min. 3 years of QC Lab Management experience in the Pharma Industry
Proficient in LIMS Software
Good leadership skills to motivate plant personnel and gain their respect
Strong working knowledge of ICH, cGMP, FDA and USP guidance
Laboratory experience with a variety of analytical instruments including, GC, UV, HPLC, IR
Candidate Nice to Have:
Advanced degree
Direct Interface experience with FDA during compliance audits.
Experience with remediation of Quality systems in FDA 483, or warning letter situations
Keywords: BioPharma, Pharma, Quality Management, FDA, QC, manufacturing, filling, Packaging
Data Quality Manager
Quality assurance manager job in New York, NY
Join Us as a Product Manager - Data Quality & Systems
Are you passionate about building systems that ensure data is accurate, reliable, and scalable? Do you thrive at the intersection of product, data, and operations? We're looking for a Product Manager - Data Quality & Systems to lead the charge in designing and implementing the frameworks that power our receipt data products-both paper and digital.
Why This Role Matters
In this role, you'll be the architect of our data quality strategy, owning the tools and processes that keep our data trustworthy. You'll work closely with our data annotation and product teams, acting as the bridge that ensures our models and client-facing products are built on a foundation of precision and integrity.
What You'll Do
Define and drive quality standards across our platform.
Develop automated testing and alerting tools to catch issues before they reach clients.
Triage anomalies and coordinate fast, effective resolutions.
Create systems that reduce manual work and improve efficiency.
Partner with Data Annotation to ensure model training meets precision/recall standards.
Set the roadmap for data QA and build a team to support it.
What You Bring
3+ years in product management, data operations, QA, or related fields.
Strong analytical skills-comfortable with SQL and BI tools.
Experience with QA frameworks and automated testing.
Excellent communicator and cross-functional collaborator.
Bonus: experience working with data annotation or labeling teams.
What Drives You
A passion for clean, high-integrity data.
A builder's mindset-ready to create and iterate.
A collaborative spirit that connects product and data teams.
Research And Development Manager
Quality assurance manager job in Bergenfield, NJ
R&D Manager
Food Manufacturing
Bergen County, NJ
You know how exciting it is when a great idea becomes a real product consumers choose every day. Not because it is trendy but because it delivers something they genuinely want. Taste. Convenience. Better nutrition. A moment of joy.
This business is growing quickly in the US and the future roadmap is ambitious. They have a clear commitment to expanding their food and beverage presence and there is serious investment behind it. The challenge now is turning opportunity into a sustained pipeline of successful launches. That is where you come in.
As Product Development Manager you will take ownership of developing products for the US market from concept through to launch. You will work closely with colleagues overseas who are responsible for the technical capabilities of formulation and packaging. Your role is to understand the US consumer, translate what the market needs, and shape products that are both exciting and commercially viable. You will also ensure the product you create truly reflects local requirements for taste, scale up, regulatory expectations and quality.
There is no large team here to hide behind. You will be trusted to operate independently, partner with co manufacturers, and make things happen by building strong relationships across functions. Innovation, cost improvements, category growth and complexity reduction will all sit within your world. And because this organisation is expanding through both organic growth and future acquisitions, what you build now helps define what comes next.
To enjoy this role you will likely be someone who has worked across multiple food and beverage categories and who understands how co manufacturing partnerships can accelerate innovation when handled well. You will be confident engaging senior stakeholders, comfortable navigating a global structure, and motivated by the idea of having real influence rather than waiting your turn.
If you want to be part of a company that is evolving fast in the US market and you like the idea of being one of the people driving that change, let us talk in confidence.
Principal Quality Engineer
Quality assurance manager job in Hauppauge, NY
BUSINESS: CIRCOR Aerospace, Inc
DIRECT REPORTING: Quality Manager
About CIRCOR Aerospace & Defense
CIRCOR Aerospace & Defense is focused on the design, development, and manufacture of specialty fluid and motion control products for demanding aerospace and defense applications. CIRCOR products are flying on most commercial and military aircraft, including single and twin aisle air transport, business and regional jets, military transports and fighters, and commercial and military rotorcraft. Other markets include unmanned aircraft, shipboard applications, and military ground vehicles.
Business units are in Hauppauge, New York; Corona, California; Warren, Massachusetts; Paris, France; Uxbridge, UK; and Tangier, Morocco. Parent company CIRCOR International is headquartered in Burlington, Massachusetts and CIRCOR Aerospace & Defense is headquartered in Corona, California.
Principal Activities
· Acting as first line QA contact for customer calls regarding product problems; then liaising internally with appropriate persons to give the customer a prompt response.
· Raising and closing In Service Defect Reports (ISDRs).
· Where appropriate raising of Corrective Action Requests (CARs) and leading root cause corrective action (RCCA).
· Participate in product improvement programs to correct in-field defects and manufacturing abnormalities.
· Working with production and other departments to resolve queries.
· Carry out detailed "root-cause analysis" and formulate corrective actions. Manage the process of driving changes and improvements as a result of this.
· Liaising with purchasing and with suppliers to resolve any supplier certification issues.
· Direct contact with customers and suppliers on QA related matters.
· Provide technical guidance on quality standards, specifications, and processes.
· Drive improvements in key defect drivers, processes, and systems to enhance assembly performance and meet site quality objectives.
CANDIDATE REQUIREMENTS
Knowledge Skills & Abilities
· A strong interest in Quality Assurance in the widest sense is prerequisite with an aptitude for problem solving and continuous improvement.
· The job holder should have an outgoing personality and be comfortable dealing with customers and internal personnel at all levels.
· Excellent problem-solving skills aimed at identifying and correcting the root causes of problems.
· Demonstrated working knowledge of problem-solving tools: 5-Whys, failure mode and effects analysis, 8-D, Pareto analysis, fault tree analysis, Bayesian inference and Ishikawa diagrams.
· Thorough knowledge of Word, Excel, Power Point, Visio, Project, and other applicable tools.
· Knowledge of Mil Spec Standards.
Education & Experience
· Bachelor's degree in Mechanical, or Manufacturing Engineering, or a technical field required with relevant work experience.
· Experience with AS9100 and/or ISO9001 quality management systems.
· Experience in Lean Six Sigma or continuous improvement practices.
· Experience with leading root cause corrective action (RCCA) and applying quality methodologies and tools.
PAY RANGE: $100K-110K. Pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience
CIRCOR is an EEO Employer of Females/Minorities/Veterans/Individuals with Disabilities
Our Benefits:
Comprehensive healthcare plans
PTO and family leave
401(K)
Work Life Balance
Career Development
Other Benefits & Perks
Why CIRCOR:
Work in a collaborative and innovative environment with a focus on professional growth.
Contribute to a diverse and inclusive workforce that values individuality and creativity.
Competitive compensation package and comprehensive benefits.
Project Quality Engineer
Quality assurance manager job in Yonkers, NY
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.
Director of Quality
Quality assurance manager job in Malverne, NY
The Director of Quality is responsible for developing, implementing, and maintaining a comprehensive quality improvement (QI) and performance management program for the Federally Qualified Health Center (FQHC). This role ensures compliance with HRSA requirements, NCQA Patient-Centered Medical Home (PCMH) standards, UDS reporting, and other regulatory or accreditation bodies, while fostering a culture of continuous improvement in clinical, operational, and patient experience outcomes.
RESPONSIBILITIES:
* Directly supervises the Quality Coordinators.
* Develops Quality Assurance policies to ensure successful implementation of improvement standards.
* Serves as the primary liaison between JPA and Managed Care Organizations (MCOs), representing the organization in all quality-related engagements and ensuring active participation in MCO quality meetings. Assesses patient medical records to ensure compliance with established quality standards.
* Coordinates and ensures timely completion of the quarterly provider peer review cycle.
* Conduct on-site visits to monitor and assess the implementation of QA/QI activities, including pre-visit planning and daily huddles.
* Aggregates statistical quality assurance data, develops comprehensive narrative reports, and partners with clinical informatics specialists to support data-driven improvements.
* Collaborates with the CMO to revise the Quality Assurance and Utilization Review plan in accordance with HRSA guidelines.
* Coordinates recurring QI/QA meetings with the Quality Coordinators and Department Leads, manages meeting coordination, records minutes, tracks participation, and ensures timely follow-up on all assigned tasks and activities.
* Monitor and track performance on HEDIS and other quality measures across payer contracts.
* Identify and prioritize care gaps in collaboration with clinical and operational teams.
* Develop and implement strategies to close care gaps, including outreach campaigns, provider engagement, and patient education.
* Collaborate with clinical teams, payors, and population health staff to align quality improvement efforts with value-based care goals. Maintain up-to-date knowledge of CMS, NCQA, and payer-specific quality measure requirements.
* Assist in the reporting and analysis of quality metrics to identify trends, disparities, and opportunities for improvement.
* Coordinate with IT and analytics teams to ensure accurate and timely data capture and reporting.
* Support the preparation of documentation and evidence for HEDIS audits and external reviews.
* Contribute to quality improvement initiatives, such as PDSA cycles, root cause analyses, and performance dashboards.
* May be required to perform other duties as assigned or when necessary.
QUALIFICATIONS:
Education:
* Bachelor's degree in healthcare administration, public health, Nursing, or related field required.
* Master's degree in public health, Healthcare Administration, or related field preferred.
* A licensed Registered Nurse (RN) or Nurse Practitioner (NP) with a strong background in healthcare quality improvement will also be considered in lieu of a master's degree.
Experience:
* Minimum 5 years of progressively responsible experience in healthcare quality or performance improvement, preferably in a community health center or FQHC setting.
* Strong working knowledge of HRSA, UDS, NCQA PCMH, and related regulatory requirements.
Skills:
* Demonstrated ability to lead quality initiatives and manage cross-functional teams.
* Proficiency in data analysis and quality improvement tools (e.g., Excel, EHR reporting, QI methodologies). Excellent verbal and written communication skills.
* Experience with risk management, clinical compliance, and patient safety programs is a plus.
Working Conditions:
* Primarily office-based with some travel between clinical sites.
* May require occasional evenings or weekends for meetings or training.
Why Join Us: Be part of a mission-driven organization focused on improving patient outcomes and advancing health equity. Collaborate with cross-functional teams to shape the future of value-based care. Opportunities for growth and professional development in a dynamic healthcare environment.
QA Director
Quality assurance manager job in New York, NY
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.
Food Safety Quality Assurance Manager
Quality assurance manager job in New York, NY
Job Description
Responsibilities
Develop and maintain food safety and QA programs per FDA and ISO standards.
Conduct quality audits to ensure regulatory and internal compliance.
Use measurement tools (e.g., micrometers, CMMs) to evaluate product quality.
Analyze QA data to identify trends and lead HACCP plan execution.
Train staff and collaborate across teams to resolve issues and drive continuous improvement.
Qualifications
Comprehensive knowledge of FDA regulations, ISO 9001, ISO 13485, and HACCP.
Proficient with micrometers and coordinate measuring machines.
Experienced in QA/QC and conducting quality audits.
Skilled in analyzing complex data for decision-making.
Calypso software experience is a plus.
Strong leadership and team management skills.
Effective communicator and team collaborator.
Food Safety Quality Assurance Manager
Quality assurance manager job in Carlstadt, NJ
& 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.
Director, Medical Affairs QA
Quality assurance manager job in Ridgefield, NJ
Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Job Summary:
Reporting to the Sr. Director, Medical Affairs QA, the Director of Medical Affairs QA is responsible for providing strategic leadership and comprehensive quality oversight across all Medical Affairs programs. This role involves deputizing for the Sr. Director, representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs.
* Support the Sr. Director's Medical Affairs Quality strategy by partnering with members and business stakeholders for both Oncology and Specialty Affairs Medical Affairs teams. Will provide strategic and proactive QA Leadership and direction for respective interventional/non-interventional programs such as post marketing studies or post approval commitments, medical access programs.
* Partner with Medical Affairs to facilitate the implementation of a risk-based quality management process fully embedded through trial design, execution and submission including all vendor managed activities with the goal of achieving the highest data quality standards, full adherence to patient's rights and well-being and in support of successful Health Authority inspections and approvals - Proactively partner and lead the strategic collaboration with other GxP Quality representatives, and act as the Quality Assurance point person for all GxP matters within the Medical Affairs team and with other related business stakeholders. Drive necessary change and efficiency through provision of effective feedback and recommendations.
* Identify and raise areas of concern where quality gaps have been identified and partner with Medical Affairs leaders to assign tasks to remove those gaps. - Provide operational QA leadership and Quality Oversight for the Quality Plan execution, Health Authority Commitments, Critical Incidents including, respective escalation and the CAPA Management Process for the respective business areas.
Responsibilities:
Leadership and Project Management:
* Lead the end-to-end quality execution across Medical Affairs programs, ensuring compliance with GCP, GPV, GPEP, Data Protection, and other local regulatory requirements throughout the planning and execution of Interventional, Non-Interventional, Managed Access Programs, and Investigator-Initiated Studies.
* Provide comprehensive quality oversight for Medical Affairs activities, including interventional studies, non-interventional studies, Compassionate Use or Managed Access Programs.
* Collaborate with the Sr Director, Medical Affairs QA to conduct quality reviews of product profiles, ensuring thorough management review of all quality and compliance topics, including Key Quality Indicators (KQIs). Identify and drive initiatives for continuous quality improvement.
* Deputize for the Sr. Director, Medical Affairs QA as needed.
Cross-functional and Global Team Participation:
* Drive quality excellence through effective business partnerships with stakeholders across functions.
* Provide leadership and guidance on assigned programs, collaborating closely with the Head of Development and Medical Affairs QA to implement the quality strategy and/or quality plan, fostering a culture of quality within Medical Affairs.
* Lead strategic initiatives in collaboration with Medical Affairs stakeholders to uphold the ethical conduct of interventional, non-interventional, investigator-initiated trials, and managed access programs to the highest quality standards.
* Act as the primary QA point of contact for all Medical Affairs programs, collaborating with GxP Quality representatives across the organization
Quality Management and Continuous Improvement:
* Lead effective communication efforts within the Medical Affairs team, ensuring collaboration with other GxP QA functions (e.g., GMP/IMP QA, Audit and Compliance, QMS QA, Development QA, and PVQA) to address GxP-related issues impacting clinical/medical access programs. Drive necessary change and efficiency through provision of effective feedback and recommendations.
* Provide leadership and direction in the development and execution of Corrective and Preventive Actions (CAPAs), ensuring timely closure, effective checks, and the proper escalation of critical issues.
* Partner with QMS QA to ensure consistent implementation of applicable Quality Standards in Medical Affairs and identify continuous improvement opportunities in quality and compliance.
* Evaluate risks impacting GxP compliance within Medical Affairs, driving ongoing improvements to meet regulatory requirements and company policies and standards.
* Interpret regulations, company standards, and guidelines for personnel involved in assigned programs or continuous improvement projects, championing and implementing study/program-specific quality plans for proactive quality management.
* Collaborate with the audit function, Data Management teams, MA stakeholders and CROs to ensure high data quality, proactively identifying and resolving issues throughout the clinical trial process.
Customer Focus / Stakeholder:
* Engagement Lead the implementation of the quality strategy in alignment with the Medical Affairs business strategy. Monitor and track the breakdown of the Quality Manual into an annual Quality Plan, including quality risk assessments and inspection readiness components for designated programs.
* Ensure proactive representation of Quality professionals in strategic project teams and GCP discussions, contributing to the broader success of Medical Affairs goals.
* Promote open communication and effective business partnering to support the cross-functional implementation of Global RD/PV QA's Strategy, Vision, and Mission.
* Cultivate a culture focused on solution-oriented, evidence-based decision-making and openness to innovative working methods and technologies across cross-functional teams.
* Ensure consistent and proactive representation of Quality at all stages of the program management process.
* May Interact with management at all levels and external audiences, leveraging a strong industry network. Represents the organization in strategic discussions and quality governance meetings.
Quality Oversight:
* Ensure the timely escalation of incidents/issues within Medical Affairs and QA, providing oversight for deviation and incident investigations, and ensuring that effective CAPAs are defined, implemented, and tracked for closure.
* Oversee quality management within Medical Affairs teams for third-party/vendor activities, ensuring that quality standards are maintained in outsourced operations.
* Ensure CAPA effectiveness checks are conducted and provide updates on quality status to business functions in a timely manner through appropriate forums, such as Quarterly Quality Reports (QQRs) and Quality Review Boards (QRBs).Collaborate with business process owners to monitor the effectiveness of clinical development processes through KQIs, demonstrating process control and ensuring compliance levels are met.
* Lead the process for reviewing and assessing KQIs regularly, preparing management documentation for the QA Head, and ensuring that any gaps or risks are addressed with continuous improvement initiatives.
* Work directly with business process owners to integrate quality into all stages of process development, ensuring stakeholders are educated on common deviations.
* Ensure proper planning and execution of and quality improvement initiatives to reduce issues to build a stronger Quality driven organization.
* Generate, analyze and report metrics to demonstrate key aspects of compliance status, escalating issues in a timely manner for earliest resolution,
Regulatory Inspections:
* Facilitates regulatory inspection preparation, management, and follow-up, ensuring thorough management review of compliance topics. Acts as a key representative during inspections and external audits. Ensure ongoing submission and inspection readiness for the respective Medical Affairs teams and related submissions, supporting the preparation and management of regulatory inspections in collaboration with business functions. Provide expert guidance to enable successful inspections.
* Lead/Support local inspections by providing adequate systems and process support, ensuring seamless execution.
* Lead lessons learned efforts based on audit findings, inspection results, regulatory intelligence, effectiveness checks, and process improvements, ensuring CAPAs are coordinated and shared to drive standardized responses and continuous learning across the organization.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education:
* Must have a Bachelor's Degree in Life Sciences, Pharmacy or Medicines required
* Master's Degree preferred
* PhD preferred
Experience:
* Must have 10 or more years of professional QA leadership experience within the pharmaceutical industry with expertise in the involvement of regulated activities for medical affairs, or clinical development. required
* Must possess a solid understanding of global health authority regulatory requirements particularly in the areas of Medical Affairs and Clinical Development; Must have a strong understanding of pharmaceutical drug development. A background in biologics would be ideal.
* Must have demonstrated knowledge and have a broad understanding of post marketing studies and post approval safety studies (PASS).
* Demonstrated experience and proven track record of successfully leading global projects with high impact with ability to lead and project-manage cross-functionally and globally with business stakeholders is highly-preferred
* Must have the proven ability to influence others and to work collaboratively with team leaders and business stakeholders cross-functionally and globally.
* Must have demonstrated ability to handle advanced problem-solving and decision-making skills, with expertise in conflict resolution and negotiation.
* Must possess strong leadership, interpersonal, communication, negotiation and problem-solving skills to be able to effectively interact and present to management at all levels as well as to external audiences and inspectors.
Travel:
* Ability to travel up to 20% both domestic and international
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range:
$180,880.00 - $271,320.00
Download Our Benefits Summary PDF
Director, Clinical Quality Assurance
Quality assurance manager job in Nutley, NJ
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
Auto-ApplyDirector, Quality Assurance
Quality assurance manager job in New York, NY
Immuneering is a clinical-stage oncology company outpacing cancer to help patients outlive their disease. Our lead product candidate, atebimetinib (IMM-1-104) is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. Immuneering's R&D team is based in a ~38,000 square foot lab and office facility in San Diego. The company also has offices in New York City and Cambridge MA. Immuneering has grown to more than 50+ employees, all working to apply their expertise, passion and creativity to improve the lives of people with serious diseases. Immuneering's team works collaboratively and relentlessly, thinking across traditional boundaries to help shape the frontiers of drug development.
General Summary of Duties:
The Director, Quality Assurance is a strategic leadership role responsible for overseeing key aspects of Quality within the organization including the development, implementation, and management of GxP (cGMP, GCP, and GLP) quality systems. To accomplish this, the candidate should have a strong knowledge of relevant regulations and be able to work cross-functionally to ensure compliance of Immuneering's ongoing development programs with local, state, federal, and international requirements. This position will be supportive in developing a culture of quality, ensuring compliance with global regulatory requirements, driving continuous improvement in quality systems, and supporting the successful development, manufacturing, and commercialization of pharmaceutical products.
A successful candidate will be a highly collaborative individual with strong interpersonal skills and will be an exceptional team player.
Specific Duties, may include but not be limited to the following:
* Assist with developing, implementing, and maintaining GxP compliant quality systems and processes to ensure compliance with FDA, EMA, ICH, and global competent authority regulations and industry guidance
* Co- lead quality audits, risk assessments, and investigations, ensuring timely resolution of quality issues.
* Work with the company's external suppliers and contract organizations to ensure consistent quality and compliance.
* Prepare for and manage inspections by regulatory agencies and commercial partners, serving as a liaison between the Company and auditors, including reporting and follow-up to any finding
* Work on qualification and validation plans, assure proper batch releases and disposition.
* Oversee resolution of any product concerns, including investigation, tracking and corrective action plans (CAPA)
* Provide quality input on contracts and serve as a point person for negotiations of quality agreements.
* Champion a culture of quality and continuous improvement across manufacturing and development operations.
Desired Skills and Qualifications
* Bachelor's degree in biological sciences or related field, with a minimum of 7 or more years experience in Quality Assurance or related fields within the pharmaceutical or biotechnology industry
* Extensive knowledge of GxP (GMP, GLP, and GCP) regulations and guidelines, including FDA, EMA, and ICH requirements
* Demonstrated hands on experience working on complex projects.
* In-depth knowledge of FDA, EMA, and ICH guidelines, regulations, and processes related to CMC.
* Strong partnering and communication skills required, as well as project management skills.
* Must be focused on working collaboratively and within our values of: Data rules, All-in, Own it (Accountable), Caring and Humble.
* Ability to work effectively in a collaborative, fast-paced environment.
Pay scale: $175-210 annually, final offer to be commensurate with education and depth of experience, with potential for equity participation, bonus and comprehensive benefits.
Location: Remote or Hybrid, if you live near an Immuneering office, regular Meet Ups are available.
Physical Demands/ Working Conditions
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role.
While extensive travel is not anticipated with this role, it is possible to perhaps up to 15% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role.
Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission.
Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam.
Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.
Director, Head of FCC Quality Assurance
Quality assurance manager job in New York, NY
Job Description
Community Federal Savings Bank (CFSB), located in New York City is seeking a highly skilled and detail-oriented Head of Financial Crimes Compliance Quality Assurance to join our Program Management & Assurance function within the Compliance department. CFSB offers a full range of banking services including ACH settlement services, pre-paid card issuance, and retail banking. In addition to serving our general customer base, we also service various types of money service businesses and FinTech companies. This individual will be primarily responsible for overseeing a robust quality assurance program to ensure compliance controls are operating as designed. They will drive strategic Financial Crimes Compliance QA initiatives, enhance transparency, and provide data-driven insights to inform decision-making and regulatory readiness.
Key Responsibilities:
Enhance and maintain the Financial Crimes Compliance Quality Assurance (QA) framework to assess whether key compliance control activities-conducted internally or by external consultants-adhere to internal standards, regulatory expectations, and Bank policy.
Implement and continuously refine standardized QA test scripts, workpapers, and documentation templates to drive consistency, transparency, and auditability across QA reviews.
Lead and develop a high-performing team of Financial Crimes Compliance QA Managers and staff, providing coaching, mentorship, and oversight to ensure effective execution and professional growth.
Partner with Internal Control functions to align Financial Crimes Compliance QA insights with broader risk trends, inform planning cycles, and enhance control evaluations across business units.
Stay current on regulatory developments, enforcement actions, and industry best practices; translate regulatory changes into QA control enhancements and update procedures accordingly.
Provide structured, actionable feedback and guidance to control owners and business partners based on QA findings, supporting the adoption of practical, risk-aligned solutions and best practices.
Lead the design and delivery of training content and workshops to improve the quality, consistency, and defensibility of investigations, control execution, and documentation.
Establish Financial Crimes Compliance QA metrics and dashboards to support continuous improvement, trend analysis, and executive-level reporting to governance committees, senior leadership, and regulators.
Ensure Financial Crimes Compliance QA processes integrate technology and data analytics where feasible to improve efficiency, risk detection, and traceability.
Act as a strategic partner across Compliance, Legal, Audit, Operations, and Technology to promote a culture of accountability, transparency, and continuous improvement.
Support internal and external regulatory examinations by providing Financial Crimes Compliance QA reporting, documentation, and commentary as needed.
Qualifications:
Deep subject matter expertise in regulatory compliance, quality assurance methodologies, and risk management within the financial services industry.
Proven ability to design and lead Financial Crimes Compliance QA programs in complex, matrixed environments involving third-party partnerships, fintech platforms, and high-risk product offerings.
Demonstrated experience presenting Financial Crimes Compliance QA findings, thematic trends, and risk insights to executive leadership, Board-level committees, and regulatory agencies.
Strong working knowledge of BSA/AML/OFAC requirements.
Strategic mindset with the ability to drive long-term program maturity while executing detailed operational reviews and initiatives.
Proficient in leveraging technology platforms to support Financial Crimes Compliance QA activities, including GRC systems, workflow tools, and automated testing solutions.
Exceptional written and verbal communication skills, with the ability to translate complex compliance matters into actionable, business-aligned recommendations.
Collaborative leader with a track record of building high-performing teams and influencing cross-functional partners across Compliance, Legal, Risk, Operations, and Technology.
Bachelor's degree required; advanced degree (e.g., JD, MBA) or relevant professional certifications (e.g., CAMS, CRCM, CISA, CFE) strongly preferred.
Minimum of 10 years of experience in Compliance, Audit, Risk, or Internal Controls, with at least 5 years in a senior leadership or QA oversight role.
Prior experience overseeing Financial Crimes Compliance QA or testing programs focused on consumer protection, AML, sanctions, or third-party oversight is highly desirable.
Exposure to dynamic and hybrid business models, such as banking-as-a-service (BaaS), money service businesses (MSBs), fintech partnerships, or international payments, is strongly preferred.
Salary: $180,000 - $210,000 K / year
"Base salary range does not include performance-based bonus and/or other benefits, where applicable. Actual base salary offer will vary based on skills and experience."
About Community Federal Savings Bank (CFSB)
Community Federal Savings Bank (CFSB) is a federally chartered bank founded in 2001 and headquartered in New York City. CFSB has focused on providing superior service and added value to clients though a solid understanding of relationship banking. We offer a full range of services, including loans, bill payments, card services, internet banking, and merchant processing.
We are an equal opportunity employer and do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, military and/or veteran status, or any other Federal or State legally-protected classes.
Director of Quality Assurance and Training
Quality assurance manager job in New York, NY
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.
Auto-ApplyQUALITY MANAGER MANUFACTURING
Quality assurance manager job in New York, NY
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
Quality Manager - Food Manufacturing
Quality assurance manager job in New York, NY
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.