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Director Quality Systems Jobs (NOW HIRING)

Balchem

Director, Quality Systems Global

Montvale, NJ · On-site

The Director, Quality Systems - Global is a key member of the Balchem Corporate Quality team and have direct accountability for Balchems Global Quality Systems, Corporate Quality Laboratory ...

B Capital

Senior Director Quality Systems

San Francisco, CA · On-site

$181.20 - $344.30/hr

About the role The Sr Director leads the Neuromodulation Quality Systems team to ensure that the company quality system policies and procedures are effectively implemented and maintained. The Sr ...

RXinsider LTD.

Sr. Director Quality Systems

San Diego, CA · On-site

$220.30 - $352.50/hr

... quality system harmonization across the entities and to drive these systems to meet changing ... Experience leading direct reports * Ability to travel and engage MMS entities worldwide to ...

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Director Quality Systems information

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$31K

$125.6K

$213.5K

How much do director quality systems jobs pay per year?

As of Aug 10, 2026, the average yearly pay for director quality systems in the United States is $125,600.00, according to ZipRecruiter salary data. Most workers in this role earn between $91,000.00 and $151,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a director quality systems?

To thrive as a Director of Quality Systems, you need deep expertise in quality management principles, regulatory compliance, process improvement, and typically a relevant degree such as in engineering or life sciences. Familiarity with quality management systems (QMS) like ISO 9001, FDA regulations, and proficiency with tools such as CAPA, risk management software, and internal audit systems is essential. Strong leadership, strategic thinking, and effective communication distinguish top performers in this role. These skills ensure the organization maintains high quality standards, meets regulatory requirements, and drives continuous improvement across all operations.

What are some common challenges faced by a director quality systems when implementing new compliance standards across an organization?

A Director of Quality Systems often encounters challenges such as resistance to change from staff, alignment of existing processes with new regulatory requirements, and ensuring consistent training across departments. Effective communication and cross-functional collaboration are key to overcoming these hurdles. The role typically involves working closely with leadership, operations, and regulatory teams to ensure that new standards are understood and integrated smoothly, minimizing disruptions while maintaining compliance.

What is a director quality systems?

A Director of Quality Systems is a senior management professional responsible for overseeing the development, implementation, and maintenance of an organization's quality management systems. They ensure that products and processes comply with industry standards, regulatory requirements, and company policies. This role often involves leading teams, developing quality strategies, conducting audits, and driving continuous improvement initiatives across the organization. Directors of Quality Systems play a critical part in safeguarding product quality, customer satisfaction, and regulatory compliance.

What is the difference between Director Quality Systems vs Quality Manager?

AspectDirector Quality SystemsQuality Manager
ResponsibilitiesOversees quality systems, compliance, and strategic quality initiatives across departmentsManages daily quality operations, audits, and team supervision
CertificationsISO 9001 Lead Auditor, CQE, Six SigmaISO 9001 Lead Auditor, CQE, Six Sigma
Work EnvironmentStrategic planning, cross-departmental collaborationOperational focus, team management
Industry UsageCommon in regulated industries like pharmaceuticals, medical devicesWidely used in manufacturing, production facilities

The main difference between a Director Quality Systems and a Quality Manager lies in scope and strategic focus. The Director typically oversees the entire quality system, ensuring compliance and strategic alignment, while the Quality Manager handles daily quality operations and team supervision. Both roles often require similar certifications and work in regulated industries, but the Director's role is more strategic and cross-departmental.

More about Director Quality Systems jobs
What cities are hiring for Director Quality Systems jobs? Cities with the most Director Quality Systems job openings:
What are the most commonly searched types of Quality Systems jobs? The most popular types of Quality Systems jobs are:
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Director Quality Systems jobs near you
Infographic showing various Director Quality Systems job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 80% Full Time, 14% Part Time, 4% Contract, and 1% Nights. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $125,600 per year, or $60.4 per hour.

Director, Quality Systems & Compliance

ElevateBio

Waltham, MA • On-site

Full-time

Re-posted 2 days ago

Job description

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.
The Role:
The Director, Quality Systems and Compliance provides strategic direction and oversight of Quality Systems, Compliance, and Business System Ownership to ensure execution meets regulatory requirements, industry best practices, and modern digital, data-driven expectations.
This role is accountable for evolving the Quality Management System (QMS) into a digitally enabled, scalable, and continuously improving ecosystem supporting clinical through commercial operations. The incumbent serves as a senior Digital System Owner leader, transforming Quality Systems into intelligent, data-driven platforms that enhance compliance, improve operational performance, and enable decision-making.
This role is a critical influencer across the organization, driving adoption and effective use of Quality Systems and ensuring they deliver measurable business value. Success requires leadership beyond traditional system management-delivering value from systems by translating compliance requirements into efficient, practical, and scalable solutions that enable the business to operate effectively and transparently while maintaining a strong compliance posture.
Here's What You'll Do:
  • Quality Systems Leadership
    • Lead and continuously improve Quality Systems, including Document Management, Training, CAPA, Deviations, Change Control, Risk Management, Supplier Quality, and Audit/Inspection Management
    • Own and drive the program for continuous inspection readiness, ensuring sustained audit preparedness through proactive monitoring, internal audits, and system effectiveness
    • Serve as the primary host and lead for client audits, including preparation, on-site execution, stakeholder coordination, and audit response strategy
    • Lead regulatory inspections and client audits, ensuring effective preparation, execution, and follow-up
    • Lead the Quality Management Review (QMR) process, monitoring system health, identifying trends and risks, and driving continuous system and process improvements
  • Digital System Ownership & AI Enablement
    • Serve as Business System Owner for eQMS, DMS, and LMS, accountable for system strategy, lifecycle, performance, and adoption
    • Drive optimization through automation, advanced analytics, and native AI capabilities
    • Implement AI-enabled use cases such as:
      • Predictive quality signal detection and trending
      • Deviation and CAPA pattern recognition
      • Automated reviews, compliance checks, and standardization of quality processes
      • Intelligent workflow routing and prioritization
    • Ensure systems remain validated and compliant with Part 11, Annex 11, and CSA expectations, while improving operational efficiency
  • Quality System Adoption & Value Realization
    • Act as a primary influencer for enterprise-wide adoption and effective use of Quality Systems
    • Ensure systems are user-centric, efficient, and enable improved execution of quality processes
    • Translate regulatory requirements into solutions that improve efficiency and support business objectives
    • Partner with functional leaders to enable transparent, compliant, and effective operations
  • Quality-IT-Digital Integration
    • Serve as the primary interface between Quality, IT, and Data/AI teams, translating business needs into scalable digital solutions
    • Ensure integration with enterprise platforms (e.g., SAP, LIMS, MES) and support implementation of emerging technologies
  • Operational Excellence & Transformation
    • Act as a Quality Operational Excellence Champion, driving process simplification, standardization, and cycle time improvements
    • Eliminate non-value-added activities and improve right-first-time performance
    • Establish and track metrics for system effectiveness, adoption, and process efficiency
  • Business System Governance
    • Lead the QMS Business System Governance process, including ownership, accountability, and prioritization of enhancements for the QMS systems
    • Participate in governance forums (e.g., Digital Steering Committees, System Boards)
    • Serve as the primary escalation point for systemic Quality System issues
  • Leadership & Culture
    • Serve as a thought leader in modern Quality Systems, advancing innovation and continuous improvement
    • Foster a culture of open-minded thinking, accountability, and innovation
    • Hold teams accountable for system utilization and performance outcomes, while empowering new ideas and approaches

Requirements:
  • 12+ years of biopharmaceutical experience with leadership in Quality Systems and Compliance
  • Demonstrated experience as a Business System Owner / Digital Process Owner in a GxP environment
  • Strong expertise in global GxP regulations and ability to translate requirements into practical solutions
  • Experience with enterprise systems (eQMS, DMS, LMS, SAP, LIMS, MES); experience with Veeva Vault is preferred
  • Experience driving digital transformation, automation, and advanced analytics initiatives
  • Familiarity with AI/ML tools and digital quality solutions in regulated environments
  • Strong understanding of data integrity, CSV/CSA, and digital system compliance requirements
  • Proven ability to influence across functions and drive system adoption, performance improvements, and inspection readiness
  • Demonstrated leadership in operational excellence, accountability, and continuous improvement
  • Ability to operate effectively in a fully digital, data-driven environment

The budgeted range for this position is $190,000 - $260,000. This range is a good faith estimate of the expected salary range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.
ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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