Director, 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