Director of Quality Jobs

Deputy Director of Quality Assurance and Quality Control

This position provides a high level of responsible, complex management and polic...

Location

United States , Honolulu

Salary:

120900.00 - 193490.00 USD / Year

Honolulu

Expiration Date

Until further notice

Requirements

A combination of education and experience substantially equivalent to graduation from an accredited college or university with major work in quality management, business administration, engineering, or a related field
five years of progressive experience in quality assurance, quality control, or related administrative or analytical field
experience must include active involvement in developing, implementing, improving QA/QC processes or programs, with demonstrated ability to analyze operations and develop effective solutions
a minimum of two years experience in a governmental agency or regulated industry, including experience supervising or managing QA/QC activities or teams
candidate must meet the health and physical condition standards necessary and proper for performing the essential duties

Job Responsibility

Assist, establish, implement, and maintain an effective Quality Management Plan for HART, including methods to investigate, monitor, regulate, and enforce quality standards
establish coordination of functions and operations across departments through the development and clear definition of quality assurance procedures
ensure HART’s compliance with applicable laws, regulations, rules, and generally accepted industry practices
provide additional oversight for the planning, analysis, inspection, design, testing, and/or integration of products and/or components to ensure compliance with HART’s quality assurance program
contribute to the development of contractor and quality specifications for design, procurement, and construction contracts
oversee internal and external audit, surveillance, and monitoring programs, ensuring compliance with HART's requirements
holds the delegated responsibility for ensuring that internal and external audits are scheduled, performed, and followed up
review HART’s activities, including contract work performed
help to identify and evaluate quality issues or work deficiencies, and initiate, recommend, or implement solutions and procedural changes as needed
guide and direct other quality assurance functions, including the conduct of quality engineering reviews of design plans, specifications, procedures, contracts, and request for proposals, for completeness and quality requirements

What we offer

Medical, prescription drug, vision, dental, and life insurance plans
generous vacation and sick leave, earning up to 21 days per year
13 paid holidays annually (14 days during election year)
retirement plan contributions through the Employees' Retirement System (ERS)
deferred compensation options to invest pre-tax income for retirement
flexible spending accounts for health and dependent care expenses
pre-tax transportation benefits, including TheBus and vanpool options
access to confidential counseling services through the Employee Assistance Program (EAP)
additional perks include training opportunities and employer-funded Holo Card for eligible employees to use on public transit
eligibility for Public Service Loan Forgiveness (PSLF) program, supporting employees dedicated to public service

Fulltime

Audit Director, Quality & Compliance

The Audit Director is responsible for leading the strategy, execution, and conti...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Life Sciences, Quality, Regulatory, or related discipline
10+ years of GxP audit experience in biotechnology, pharmaceutical, or cell therapy environment
Demonstrated experience leading internal and external GxP audits
Strong understanding of FDA, EMA, MHRA, and ICH regulations (including ICH E6 R3, Annex 1, 21 CFR Parts 210/211/312/820, GCP/GMP/GLP)
Experience supervising or mentoring employees
Strong analytical, organizational, and communication skills
Ability to manage competing priorities in a fast-paced, rapidly growing company
Experience in advanced therapies, ATMPs, or cell/gene therapy manufacturing preferred
Experience preparing for and supporting regulatory inspections preferred
Certifications such as ASQ, RQAP-GCP/GMP, RAC, CQA, or equivalent preferred

Job Responsibility

Develop and maintain the annual risk-based Internal Audit Program across GCP, GMP, GLP, IT/CSV, and Quality Management System (QMS) domains
Plan, schedule, and execute internal audits, vendor audits, and for-cause audits
Ensure alignment with global regulatory requirements and industry best practices for advanced therapies and cell therapy manufacturing
Evaluate organizational risk and adjust audit scope and approach accordingly
Directly supervise the current audit team member including goal setting, workload planning, performance management, and professional development
Provide coaching, technical training, and oversight to ensure audit readiness and consistent application of audit standards
Support team succession planning and capability building as the audit function grows
Lead or oversee audits of internal functional areas (e.g., Clinical Operations, CMC, MSAT, Manufacturing, Quality Control, Regulatory Affairs, IT)
Oversee vendor and third-party audits to qualify and maintain GxP suppliers
Ensure timely issuance of audit reports, management responses, and CAPA plans

What we offer

health and retirement, PTO, and stock option plans

Japan Quality Director

Lead quality assurance and compliance for a global biopharmaceutical leader in J...

Location

Japan , Tokyo

Salary:

18000000.00 - 22000000.00 JPY / Year

Randstad

Expiration Date

March 12, 2026

Requirements

Bachelor's degree in pharmacy, life sciences, or a related field
Minimum 10 years of experience in the pharmaceutical industry, with at least 7 years in Quality Management Systems
Expert knowledge of GMP, GDP, and Japanese pharmaceutical regulations
Proven experience leading and managing a team of quality assurance professionals
Strong understanding of quality risk management principles and techniques
Excellent communication and collaboration skills, including fluency in Japanese and English
Proven ability to interact effectively with health authorities and external partners
Strong leadership skills with the ability to build consensus and drive results
Experience with SAP systems is preferred
Experience in product recall and field action management

Job Responsibility

Implement and maintain the Local Quality Management System (QMS)
Oversee quality control for pharmaceutical products, ensuring compliance with GMP/GDP standards
Manage deviations, CAPAs, complaints, and change control processes
Lead supplier management, including qualification and selection of new vendors
Represent the company with health authorities and other external stakeholders
Collaborate with global quality teams, ensuring consistent application of quality standards
Manage and develop a team of quality assurance professionals
Lead internal audits and inspections, ensuring regulatory compliance
Manage product recalls and field actions, collaborating with various teams and stakeholders

What we offer

Health insurance
Employee pension insurance
Unemployment insurance
Weekends and public holidays off

Fulltime

Senior Director, Quality Engineering

The Senior Director of Quality Engineering is a transformational leadership role...

Location

United States

Salary:

116100.00 - 191500.00 USD / Year

One Call

Expiration Date

Until further notice

Requirements

12+ years of progressive experience in software quality engineering, with at least 5+ years in leadership roles
Proven track record of transforming QA organizations into modern, automated QE functions
Deep expertise in test automation, CI/CD, DevSecOps, and agile delivery practices
Experience implementing AI-powered testing tools and frameworks (e.g., model-based testing, intelligent test generation, predictive analytics)
Hands-on experience with enterprise-scale applications and distributed systems
Strong understanding of hybrid cloud environments, microservices architecture, and containerized deployments
Experience managing global teams and vendor partnerships
Exceptional communication, executive presence, and stakeholder engagement skills
Expertise in test automation tools (e.g., Selenium, Playwright, Cypress), performance testing (e.g., JMeter, Gatling), and API testing (e.g., Postman, RestAssured)
Familiarity with AI/ML-based testing platforms and observability tools

Job Responsibility

Define and execute the quality engineering strategy aligned with One Call’s digital transformation and platform modernization goals
Lead the transition from manual QA to automated QE, embedding quality early in the PDLC and driving a shift-left culture
Champion the use of AI-driven testing tools and frameworks to improve coverage, accelerate feedback loops, and reduce regression risk
Partner with Engineering, Product, and Delivery leaders to ensure quality is a shared responsibility across teams
Build and scale automation frameworks for functional, performance, security, integration and production validation testing across web, application and API layers
Drive adoption of CI/CD-integrated testing pipelines to enable frequent, reliable releases
Establish and enforce quality gates, test data management practices, and defect triage processes
Define and track KPIs for test coverage, defect leakage, automation rates, release frequency, and cycle time
Drive measurable improvements in product quality, release confidence, and customer satisfaction
Provide transparency into quality metrics and trends across teams and applications

What we offer

Remote Work: We are a remote-first company, and almost all positions receive the flexibility of working from home
Generous Time Off: Besides 8 company holidays and 2 personal days every year, all colleagues receive a minimum of 18 days of paid time off
Comprehensive Benefits Package: Including medical, dental, vision, and pet insurance
401(k) matching program
and company-paid life insurance and short and long-term disability coverage
Supportive Services: We offer a Colleague Assistance Program that provides free counseling and financial services, and our One Call Foundation, a non-profit arm of our company, provides colleagues financial assistance during times of unexpected hardships

Fulltime

New

Director - Quality

Director - Quality - TMCOne. Develops, coordinates, and directs the implementati...

Location

United States , Tucson

Salary:

Not provided

Tucson Medical Center

Expiration Date

Until further notice

Requirements

Bachelor’s degree from an accredited institution in a related field
Seven (7) to ten (10) years of quality experience or demonstrated clinical/quality improvement results
Certified Professional in Healthcare Quality (CPHQ) required
Must possess a comprehensive knowledge of health care operations
Must possess advance knowledge in Quality including Joint Commission and CMS regulatory requirements, HCAHPS and pay for performance requirements, knowledge of quality tools such as Root Cause Analysis and Kaizen and knowledge of reporting requirements and systems
Must have the ability to develop, coordinate, implement and evaluate the effectiveness of quality programs and process excellence for the health care system
Must possess well-developed project management, process redesign, and analytical skills. Leadership experience overseeing progressively complex projects and interfacing with executive leaders
Must possess excellent communication skills to interact with physicians, patients/ family, community health care system staff and external reviewers. Ability to motivate others to drive change and ability to communicate respectfully and collaboratively around improvement opportunities
Must be comfortable operating in a collaborative, shared leadership environment. Demonstrated ability to effectively establish and maintain working relationships with peers at all levels of the organization

Job Responsibility

Develops, coordinates, and directs the implementation of the Quality Performance Program
Leads the Quality Performance Indicator (QPI) program and communicates QPI activities throughout the organization
Is responsible for the design, implementation, and on-going maintenance of quality programs
Participates in organizational quality planning and takes ownership of implementation of strategic activities that fall within quality domains
Ensures organizational alignment with TMC’s quality standards
Active in developing a culture to improve the patient care experience, regulatory goals, and all operational metrics such as: patient safety, quality, productivity and patient, physician, and employee satisfaction
Provides expert guidance and support to the organization by working with the quality team to identify opportunities for competency development and performance improvement and achieves improvement results
Areas of responsibility include quality, abstractors, quality analysts, and accreditation
Responsible for all accreditation activities for the organization
Effectively manages staff

Fulltime

New

Director, Quality

Directs the department's activities and resources to achieve departmental and or...

Location

United States , Gallatin

Salary:

Not provided

Copper Springs East

Expiration Date

Until further notice

Requirements

Current State of Tennessee or Multi-State Registered Nurse licensure
BLS certification from the American Heart Association (AHA) or American Red Cross (ARC) - Required to be current upon hire
Bachelor's Degree in Nursing required
Must have acute hospital quality experience

Job Responsibility

Develops and implements departmental goals, plans, and standards consistent with the clinical, administrative, legal, and ethical requirements/objectives of the organization
Directs and evaluates departmental operations, including patient care delivery, information technologies, service level determination, and complaint management, to achieve performance and quality control objectives
Plans and monitors staffing activities, including hiring, orienting, evaluating, disciplinary actions, and continuing education initiatives
Prepares, monitors, and evaluates departmental budgets, and ensures that the department operates in compliance with allocated funding. Coordinates and directs internal/external audits
Creates and fosters an environment that encourages professional growth
Integrates evidence-based practices into operations and clinical protocols
Regular and reliable attendance
Perform other duties as assigned

What we offer

Comprehensive medical, dental, and vision plans, plus flexible-spending and health- savings accounts
Competitive paid time off for full-time employees
Income-protection programs, such as life, accident, critical-injury insurance, short- and long-term disability, and identity theft coverage
Tuition reimbursement, loan assistance, and 401(k) matching
Employee assistance program including mental, physical, and financial wellness
Professional development and growth opportunities

Fulltime

New

Director, Quality

Leads and oversees a comprehensive, efficient, and integrated hospital-wide Cont...

Location

United States , Waukesha

Salary:

Not provided

Copper Springs East

Expiration Date

Until further notice

Requirements

Registered Nurse with current state licensure highly preferred
clinical license required
BSN or BS/BA required
Minimum two (2) years in an acute hospital or rehabilitation setting required
prior supervisory experience preferred
Basic Life Support (BLS/CPR) required
certification preferred by APIC (American Practitioners of Infection Control) and NAHCQ (National Association of Health Care Quality)
Data analysis and reporting
CQPI methodologies (e.g., RCA, FMEA, PDSA)
risk management and patient safety facilitation

Job Responsibility

Provide leadership and oversight of the organization-wide CQPI program
Measure and assess performance by collecting, analyzing, and trending data to identify opportunities for improvement
Focus on improving processes and systems to drive clinical quality, safety, and operational performance
Direct, facilitate, and report on all aspects of risk management and patient safety
Investigate factors contributing to adverse outcomes and drive process/system changes
Direct the hospital-wide CQPI operations, including record reviews for quality indicators and reporting findings to leadership, Medical Executive Committee, Board of Managers, and other committees
Annually review hospital-wide plans for Infection Control (IC) and CQPI
establish goals and objectives for the coming year
Serve as liaison to local health officials
coordinate inspections and accreditation reviews with state and other regulatory agencies

What we offer

Health (Medical, Dental, Vision) and 401K Benefits for full-time employees
Competitive Paid Time Off
Employee Assistance Program - mental, physical, and financial wellness assistance
Tuition Reimbursement/Assistance for qualified applicants

Fulltime

Senior Director Quality Assurance

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , West Greenwich

Salary:

218358.00 - 252850.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of Quality/Manufacturing/Engineering experience
Master’s degree and 8 years of Quality/Manufacturing/Engineering experience
Bachelor’s degree and 10 years of Quality/Manufacturing/Engineering experience
At least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Job Responsibility

Lead Plant QA team providing Quality Oversight of 24/7 continuous manufacturing operation and high impact strategic decision making in two (2) multi-product Drug Substance facilities
Scope includes on-the-floor support for AR5 Fed batch and AR30 MoF, I-530, Buffer Preparation Area, Media Preparation, Component Preparation Area, In Process Testing Lab, record review, quality oversight of deviation investigations and changes, document approval, and disposition
Ensure drug substance is manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Amgen standards, and other applicable regulations and specifications
Provide oversight to ensure that Amgen Quality Management System is implemented and maintained in accordance with corporate standards
Track performance and drive continuous improvement in the performance and delivery of quality outputs in alignment with Quality strategies
Provide quality input and partner with cross-site and cross-functional area leads to advance Amgen’s manufacturing strategy
Develop strategies in support of regulatory inspections and site audits
Serve as quality representative to regulatory authorities, Amgen Corporate auditors, and 3rd Parties
Develop area budget, manage expenditure and identify productivity improvement opportunities
Represent ARI Quality in cross-function and cross-site forums

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans

Fulltime

Director of Quality

Copper Springs East

Location:
United States , Lynchburg

Category:
Nursing

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
December 27, 2025

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