ZipRecruiter

Log In

1

Associate Director Quality System Compliance Jobs

Piramal Pharma Limited

... Associate Director, Quality Assurance provides leadership and oversight of Quality Operations ... The role ensures compliance with cGMP requirements, data integrity standards, computer system ...

New

MSD

Associate Director Quality

West Point, PA · On-site

... System, and Risk Management to maintain compliance with regulatory requirements. The individual is ... The Associate Director drives quality improvement activities and ensures alignment across the ...

New

Replimune-2

Director, Quality Systems

Framingham, MA · On-site

$191K - $247K/yr

The Director, Quality Systems has the opportunity to create influential and collaborative ... Oversee/Manage a compliant and effective Quality System as described in ICH Q10 including the ...

TG Therapeutics, Inc.

The role is expected to evaluate complex manufacturing and compliance issues, develop clear and ... TG's Quality Management System (QMS). The role requires proactive ownership, strong ...

Baxter

Associate Director, Quality

Hayward, CA

$160K - $220K/yr

... quality system for the plant, assuring systems and procedures for regulatory compliance are ... Direct large-scale programs and departmental initiatives in support of division-wide and company ...

next page

Showing results 1-20

All JobsTechnology JobsSoftware JobsDirector Of Software Development JobsAssociate Director Quality System Compliance Jobs

Associate Director Quality System Compliance information

See salary details

$31K

$125.6K

$213.5K

How much do associate director quality system compliance jobs pay per year?

As of Sep 13, 2026, the average yearly pay for associate director quality system compliance 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 does an associate director quality system compliance do?

An Associate Director of Quality System Compliance is responsible for overseeing and ensuring that an organization's quality management systems meet regulatory standards and internal policies. They develop, implement, and monitor quality assurance processes, lead audits, and manage compliance with industry regulations such as FDA, ISO, or GMP. Additionally, they often supervise a team, provide training, and collaborate with other departments to maintain continuous improvement in quality practices. Their role is critical to minimizing risk and ensuring products or services consistently meet quality and safety requirements.

What are the key skills and qualifications needed to thrive as an associate director quality system compliance?

To excel as an Associate Director Quality System Compliance, you need deep expertise in quality management systems, regulatory requirements (such as FDA, ISO), and a relevant bachelor’s or advanced degree. Familiarity with quality management software, risk management tools, and certifications like Six Sigma or ASQ are commonly required. Leadership, strategic thinking, and strong communication skills are essential for driving compliance initiatives and collaborating across departments. These competencies ensure the organization maintains regulatory standards, mitigates risks, and delivers high-quality products.

What are some common challenges faced by an associate director quality system compliance, and how can they be effectively managed?

One common challenge for an Associate Director of Quality System Compliance is balancing strict regulatory requirements with operational efficiency. This role often requires navigating complex regulations and ensuring all processes meet compliance standards without slowing down production or innovation. Effective management involves fostering strong cross-functional relationships, staying updated on industry changes, and implementing robust training programs for staff. Proactively identifying potential compliance gaps and encouraging a culture of continuous improvement also help address challenges before they escalate.

What is the difference between Associate Director Quality System Compliance vs Quality Assurance Manager?

AspectAssociate Director Quality System ComplianceQuality Assurance Manager
ResponsibilitiesOversees compliance with quality systems, regulatory standards, and audits at a strategic levelManages daily quality assurance activities, inspections, and process improvements
CredentialsTypically requires advanced degrees and certifications like RAC or ISO auditor trainingOften requires a bachelor's degree and QA certifications such as ASQ CQE or CQA
Work EnvironmentStrategic, cross-departmental, often in corporate or regulatory settingsOperational, hands-on, in manufacturing or laboratory environments
Industry UsageCommon in biotech, pharma, and medical device companiesWidely used across manufacturing, biotech, and healthcare sectors

The Associate Director Quality System Compliance focuses on strategic compliance oversight and regulatory adherence, while the Quality Assurance Manager handles daily QA operations and process improvements. Both roles are vital in maintaining quality standards but differ in scope and focus.

What are popular job titles related to Associate Director Quality System Compliance jobs?

For Associate Director Quality System Compliance jobs, the most frequently searched job titles are:

Infographic showing various Associate Director Quality System Compliance job openings in the United States as of September 2026, with employment types broken down into 2% As Needed, 80% Full Time, 14% Part Time, 3% Contract, and 1% Nights. Highlights an 83% Physical, 1% Hybrid, and 16% Remote job distribution, with an average salary of $125,600 per year, or $60.4 per hour.

Associate Director, Quality Systems and Compliance

New York, NY • Hybrid

Lexeo Therapeutics
Biotechnology Research and Development • 11 - 50 employees
Learn more about Lexeo Therapeuticsexternal

$158K - $207K/yr

Full-time

Re-posted 9 days ago

Job description

Role Summary 

We are seeking an experienced Associate Director, Quality Systems & Compliance to lead strategic oversight and continuous improvement of our Quality Management System (QMS), Document Control for Policies, SOPs, Work Instruction & forms, and GxP as well as some non GxP Training programs. This individual will play a critical role in ensuring our quality infrastructure supports the development and commercialization of innovative gene therapies while maintaining compliance with applicable global regulatory requirements. 

The successful candidate will be a hands-on leader with extensive experience implementing and managing electronic quality systems, developing and maintaining controlled documentation, and administering enterprise-wide training programs within a biotechnology or pharmaceutical environment. 

Primary Responsibilities
  • Provide strategic leadership and operational oversight for the Quality Management System (QMS), Document Control, and Training functions
  • Serve as the business owner and subject matter expert for the electronic Quality Management System (eQMS), ensuring system performance, compliance, and continuous improvement
  • Lead the development, review, approval, implementation, and lifecycle management of Standard Operating Procedures (SOPs), work instructions, policies, and quality records
  • Oversee document control processes, including document issuance, revision control, archival, and periodic review
  • Manage GxP and non-GxP training programs, ensuring timely assignment, completion, effectiveness, and compliance with regulatory expectations
  • Develop quality metrics and dashboards to monitor system performance and identify opportunities for continuous improvement
  • Partner with Quality Assurance, Regulatory Affairs, Manufacturing, Technical Operations, Clinical Development, and other cross-functional teams to ensure quality system effectiveness
  • Support internal audits, external audits, regulatory inspections, and supplier audits related to Quality Systems, documentation, and training
  • Ensure Quality Systems remain aligned with FDA, EMA, ICH, and applicable global regulatory requirements
  • Lead and mentor Quality Systems personnel, fostering a culture of compliance, accountability, and continuous improvement.
Required Skills and Qualifications
  • Bachelor's degree in Life Sciences, Engineering, Quality, or a related scientific discipline; advanced degree preferred
  • 10+ years of Quality Assurance experience within biotechnology, pharmaceutical, cell therapy, or gene therapy industries, including progressive leadership responsibilities
  • Demonstrated experience managing enterprise Quality Systems in a regulated GxP environment
  • Advanced proficiency with eQMS, preferably ZenQMS, including administration, configuration, workflow management, reporting, and user support
  • Extensive experience developing, revising, implementing, and managing Standard Operating Procedures (SOPs) and controlled quality documentation
  • Demonstrated expertise managing both GxP and non-GxP training programs, including curriculum development, training assignments, compliance monitoring, and effectiveness assessments.
Preferred Qualifications
  • Experience supporting gene therapy, cell therapy, biologics, or other advanced therapeutic products
  • Strong understanding of FDA, EMA, ICH, and global GxP regulations
  • Experience leading Quality System implementations, upgrades, or continuous improvement initiatives
  • Excellent communication, organizational, and project management skills
  • Proven ability to influence cross-functional stakeholders and lead through change in a fast-paced, growing organization
$158,400 - $207,000 a year
Compensation is dependent on qualifications and experience

About LEXEO 

Lexeo Therapeutics is a clinical-stage genetic medicine company headquartered in New York City, pioneering cardiac genetic medicine candidates to treat the root causes of inherited cardiovascular diseases. Our lead program, LX2006, targets cardiomyopathy associated with Friedreich's Ataxia and anchors a broader pipeline addressing genetically defined conditions such as hypertrophic and arrhythmogenic cardiomyopathies. Backed by a strong financial foundation, Lexeo is positioned to translate groundbreaking science into durable clinical impact. 

Our work culture is a hybrid model with 2 days/week in the New York City office and 3 days working from home.

LEXEO Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment. 

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
apply for this job

Apply