Global Quality Director Job at BrainWorks (Chicago)

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

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

Senior Director, Quality Control Analytical Sciences

We are seeking a Senior Director, Quality Control (QC) Analytical Sciences, to l...

Location

Salary:

245000.00 - 260000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

PhD in relevant discipline (e.g., analytical biochemistry or relevant field)
15+ years of QC experience with complex biologics, particularly monoclonal antibodies, spanning late-stage development and commercialization
Proven people leader with a growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment
Excellent communicator with an ability to present to and be understood by a variety of stakeholders and tailor message accordingly
Experience with regulatory filing preparation and messaging across global jurisdictions
Deep knowledge and understanding of relevant global regulatory guidance and requirements
Ability to keep pace with a fast-moving organization
Availability to participate in calls across multiple international time zones
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
Ability and willingness to travel up to 30%

Job Responsibility

Lead QC Analytical Sciences team, responsible for QC activities for all pipeline programs including strategies for phase-appropriate method qualification, validation, and transfer for drug substance, drug product, and drug-device combination testing
in-process/release/stability testing
specification justification and maintenance
shelf-life management
and critical documentation
Partner with new and existing external QC testing labs and CDMOs, managing relationships and all relevant activities in collaboration with TechOps Program Management, Quality Assurance, and Manufacturing
Develop analytical regulatory strategies and prepare relevant Module 3 regulatory documents
Contribute to a mature QC infrastructure, implementing processes and procedures to support the development of therapeutic candidates in a GMP-compliant manner
Monitor data trends, troubleshoot QC method performance, and investigate OOT/OOS results

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Director of Quality Engineering

HMH is a learning technology company committed to delivering connected solutions...

Location

India , Pune

Salary:

Not provided

EdTech Jobs

Expiration Date

Until further notice

Requirements

15+ years of experience in software quality engineering
At least 7+ years in leadership roles overseeing QA/QE or Platform Engineering
Proven experience managing large engineering teams across geographies, preferably 50+ team members
Demonstrated success leading AI/automation initiatives within engineering or quality organizations
Deep expertise in modern testing strategies, CI/CD pipelines, cloud-native architectures, and tooling
Strong understanding of SDLC, release governance, and large-scale program execution
Excellent communication, stakeholder management, and leadership presence
Ability to operate in a fast-paced, matrixed global environment

Job Responsibility

Provide on-the-ground leadership for all QE teams in Pune, ensuring strong engagement, alignment, and execution
Develop and execute a strategy to elevate engineering maturity, strengthen delivery discipline, and scale operational excellence
Serve as a key member of the global engineering leadership team, driving alignment across geographies and business units
Engage with cross-functional teams, including product managers and business leaders, to align technical efforts with company objectives
Lead adoption and integration of AI, autonomous testing solutions, and agentic workflows to improve efficiency, accuracy, and delivery velocity
Champion innovation in automation frameworks, intelligent observability, and predictive analytics across QE
Evaluate and drive implementation of advanced tooling and platforms to enhance productivity
Oversee roadmap delivery for Platform and Curriculum initiatives, ensuring commitments are met with speed, reliability, and quality
Establish strong governance, release management rigor, and continuous improvement practices
Partner closely with Product, Architecture, Engineering, and Program teams to ensure seamless end-to-end delivery

Fulltime

Global Marketing Director, Obesity - Cardiovascular

In this vital role you will provide strategic input into the development of busi...

Location

United States

Salary:

214781.00 - 248300.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of commercial experience
Master’s degree and 7 years of commercial experience
Bachelor’s degree and 9 years of commercial experience

Job Responsibility

Leading the design of key strategies, programs and plans that will support the commercialization of the obesity portfolio for obesity cardiovascular related priorities and initiatives
Developing deep customer understanding and building comprehensive marketing strategies aligned with overall business objectives
Leading cross-functional teams to identify and prioritize key initiatives and opportunities for the brand and drive their successful execution
Lead and facilitate key strategic workshops leading to launch and commercialization
Develop and implement strategic frameworks to drive key decisions and actions
Act as central point to identify and resolve critical milestones to ensure flawless launch execution
Foster ongoing insights development by partnering internally and externally and using this to drive critical strategic choices for the brand
Support the execution of launch and commercialization activities, focusing on global and priority markets
Monitoring and analyzing market trends, competitive landscape, and industry developments to inform and adjust the strategy as needed
Representing the company at industry events and conferences and build relationships with key opinion leaders and other external partners

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, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Global Production Director

The Global Production Director is tasked with overseeing and advancing the plann...

Location

Spain , Madrid

Salary:

Not provided

Fever

Expiration Date

Until further notice

Requirements

8–10 years in live entertainment production with a focus on creative involvement
Strong leadership, creative evaluation, and project management skills
proven ability to manage multiple projects concurrently
Bachelor’s degree in Production, Fine Arts, Business, or a related field (or equivalent experience)
Familiarity with global live entertainment markets, regional nuances, and emerging industry trends
Availability to travel internationally as required

Job Responsibility

Develop comprehensive plans for permanent attraction projects by coordinating cross-functional teams to align on goals, budgets, and timelines
Conduct feasibility studies for potential expansion opportunities, assessing resource needs, estimated costs, and operational impacts
Drive the creation of a phased expansion roadmap, aligning with corporate growth strategies
Lead and manage production teams to deliver all projects within the agreed scope, ensuring adherence to schedules and budgets
Establish and implement standardized production processes to maintain consistency and quality across various project types and across geographies
Act as a key decision-maker for high-stakes issues related to technical requirements, resource allocation, and vendor selection
Assess current work methods / production workflows / local processes and challenge proposed approaches and provide creative alternatives, suggestions to improve ongoing projects
Build, train, and manage production teams specializing in permanent attractions
Support the professional growth of team members through ongoing training, mentoring, and performance feedback
Ensure local producers have the necessary tools, resources, and guidance

What we offer

40% discount on all Fever events and experiences
Work in the centre of the city with opportunities to travel
Responsibility from day one and professional and personal growth and the opportunity to have a real impact in a high-growth global category leader
Health and dental Insurance
Wellhub membership
Flexible remuneration plan
Great work environment with a young, international team of talented people to work with

Fulltime

Director, Global Reporting and Business Analytics

Strategic and operational leader to drive reporting excellence and digital enabl...

Location

Spain , Barcelona; Madrid

Salary:

Not provided

LHH

Expiration Date

Until further notice

Requirements

7+ years' experience in business reporting and analytics
5+ years direct management experience
Ability to manage offshore resources
Strong proficiency in reporting tools and platforms (Salesforce, MicroStrategy, Power BI, Excel)
Experience managing data accuracy and troubleshooting inconsistencies
Experience owning and evolving digital learning platforms
Demonstrable experience centralizing and standardizing operations processes
Experience influencing change and progress in a highly matrixed environment
Excellent written and verbal communication skills
Ability to collaborate with global partners and all lines of business

Job Responsibility

Partner with in country and global leaders across all lines of business to standardize and simplify business reports
Ensure timely and accessible delivery of all standard reports and ad-hoc requests
Troubleshoot reporting errors and inconsistencies in standard reports
Ensure automation and reporting projects are prioritized correctly and executed
Establish standard processes to request support and KPIs for quality and timeliness
Lead LHH reporting workstreams to ensure global consistency and accuracy
Manage Global NPS for CTM and LD
Manage Annual PWC Audits from a Data and Reporting perspective
Own and evolve the Digital Learning Campus for internal colleagues and clients
Coordinate with digital learning team to set up client-specific DLC sites

What we offer

Growth opportunities within a human resources global leader
Priority on learning to stay agile
Open-minded environment fostering new ideas
Comprehensive benefits package including health, PTO, Paid Holidays
Base salary + Bonus

Fulltime

Director, Global Reporting and Business Analytics

Strategic and operational leader to drive reporting excellence and digital enabl...

Location

Canada

Salary:

Not provided

LHH

Expiration Date

Until further notice

Requirements

7+ years' experience in business reporting and analytics
5+ years direct management experience
Ability to manage offshore resources
Strong proficiency in reporting tools and platforms (Salesforce, MicroStrategy, Power BI, Excel)
Experience managing data accuracy and troubleshooting inconsistencies
Experience owning and evolving digital learning platforms
Demonstrable experience centralizing and standardizing operations processes
Experience influencing change and progress in a highly matrixed environment
Excellent written and verbal communication skills
Ability to collaborate with global partners and all lines of business

Job Responsibility

Partner with in country and global leaders across all lines of business to standardize and simplify business reports
Ensure timely and accessible delivery of all standard reports and ad-hoc requests
Troubleshoot reporting errors and inconsistencies in standard reports
Ensure automation and reporting projects are prioritized correctly and executed
Establish standard processes to request support, and KPIs for quality and timeliness of deliverables
Lead LHH reporting workstreams to ensure global consistency and accuracy across all data sources
Manage Global NPS for CTM and LD along with stakeholders
Manage Annual PWC Audits from a Data and Reporting perspective
Own and evolve the Digital Learning Campus for internal colleagues and clients
Manage vendor contracts for DLC platforms, renewals, and amendments

What we offer

Growth opportunities within a human resources global leader
Priority on learning to stay agile in competitive business environment
Open-minded environment where people spark new ideas and explore alternatives
Comprehensive benefits package including health, PTO, Paid Holidays
Base salary + Bonus

Fulltime

Global Quality Director

BrainWorks

Location:
United States , Chicago

Category:
Manufacturing

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 15, 2026

Looking for more opportunities? Search for other job offers that match your skills and interests.

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BrainWorks

Location:United States , Chicago

Category:Manufacturing

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:January 15, 2026

Looking for more opportunities? Search for other job offers that match your skills and interests.

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Location:
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Job Posted:
January 15, 2026