Oversee system lifecycle activities including impact assessments, change management, periodic ... Quality & Regulatory Compliance * Ensure all computerized systems maintain compliance with 21 CFR ...
Oversee system lifecycle activities including impact assessments, change management, periodic ... Quality & Regulatory Compliance * Ensure all computerized systems maintain compliance with 21 CFR ...
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Oversee system lifecycle activities including impact assessments, change management, periodic ... Quality & Regulatory Compliance * Ensure all computerized systems maintain compliance with 21 CFR ...
Oversee system lifecycle activities including impact assessments, change management, periodic ... Quality & Regulatory Compliance * Ensure all computerized systems maintain compliance with 21 CFR ...
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San Antonio, TX · On-site
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Charleston, SC · On-site
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Charleston, SC · On-site
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Charlotte, NC · On-site
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Communication, Growth, Inclusion, Philanthropy, Quality, Transparency. If you thrive in a high ... the systems that keep us protected as we scale. If you're methodical, calm under pressure, and ...
Compliance Manager
Charlotte, NC · On-site
$125K - $145K/yr
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Quality System Compliance Manager information
See salary details
$54K - $63.1K
8% of jobs
$63.1K - $72.2K
12% of jobs
$75.2K is the 25th percentile. Wages below this are outliers.
$72.2K - $81.3K
17% of jobs
The median wage is $89.4K / yr.
$81.3K - $90.4K
15% of jobs
$90.4K - $99.5K
12% of jobs
$99.5K - $108.5K
6% of jobs
$117.2K is the 75th percentile. Wages above this are outliers.
$108.5K - $117.6K
5% of jobs
$117.6K - $126.7K
6% of jobs
$126.7K - $135.8K
13% of jobs
$135.8K - $144.9K
3% of jobs
$144.9K - $154K
2% of jobs
$54K
$98.6K
$154K
How much do quality system compliance manager jobs pay per year?
What does a quality systems and compliance manager do?
What is the salary for a quality manager?
What is the role of a quality compliance manager?
How does a Quality System Compliance Manager typically collaborate with cross-functional teams to ensure regulatory adherence?
What is the difference between Quality System Compliance Manager vs Quality Assurance Specialist?
| Aspect | Quality System Compliance Manager | Quality Assurance Specialist |
|---|---|---|
| Certifications | ISO 9001 Lead Auditor, CQE | ASQ certifications, ISO 9001 awareness |
| Work Environment | Regulatory compliance, quality management systems | Product testing, process inspection |
| Employer & Industry | Manufacturing, healthcare, aerospace | Manufacturing, software, consumer goods |
The Quality System Compliance Manager focuses on ensuring organizational adherence to quality standards and regulatory requirements, often managing compliance programs. The Quality Assurance Specialist primarily conducts product testing and inspections to verify quality. While both roles aim to improve quality, the Compliance Manager emphasizes system-wide adherence, whereas the Specialist concentrates on product-level quality assurance.
Is QMS a good career?
What does a Quality System Compliance Manager do?
What are the key skills and qualifications needed to thrive as a Quality System Compliance Manager, and why are they important?

Associate Director, Computer System Validation & Quality Compliance
Amylyx PharmaceuticalsCambridge, MA • On-site, Remote
Other
Posted 8 days ago
Job description
The Opportunity
The Associate Director, Computer System Validation (CSV) & Quality Compliance provides enterpriselevel leadership, strategic direction, and governance for the validation, lifecycle management, and continuous compliance of GxPrelevant computerized systems, with a strong emphasis on the Veeva Quality Suite. This role ensures that digital quality solutions and supporting systems meet global regulatory requirements (FDA, EMA, ICH, GAMP 5), maintain data integrity, and enable a sustainable, inspectionready state across the organization.
This person will partner closely with Quality, IT, Regulatory, Clinical, and business process owners to define system requirements, lead new system implementations and major enhancements, and drive harmonized, riskbased validation practices. This role also oversees quality compliance processes such as Change Control, Deviations, CAPA, and continuous improvement, ensuring timely closure, trend analysis, and effective governance through leadership of key forums including Quality Management Review and crossfunctional compliance meetings.
Responsibilities
Strategic Leadership & Governance
- Develop, evolve, and steward the corporate CSV/CSA strategy, ensuring alignment with enterprise digital strategy and Quality Management System (QMS) objectives.
- Serve as the senior Quality authority for computerized systems validation, data integrity, and electronic system compliance.
- Oversee enterprise-wide governance programs, ensuring standardized, riskbased approaches to system implementation and maintenance.
- Provide strategic guidance to senior leadership regarding system performance, risks, and compliance maturity.
Computer System Validation & Lifecycle Oversight
- Lead planning, execution, review, and approval of validation deliverables across GxP systems.
- Oversee system lifecycle activities including impact assessments, change management, periodic reviews, audit trails, user access reviews, and system retirement.
- Promote and reinforce CSAaligned, riskbased validation practices to streamline compliance and maximize efficiency.
- Ensure documentation quality and consistent application of SDLC principles across projects.
Veeva Systems Expertise & Optimization
- Serve as the Quality SME for the Veeva Quality Suite, providing expert guidance on configuration, workflow optimization, and release readiness.
- Lead implementation, enhancement, and optimization of Veeva Vault modules and crossfunctional integrations.
- Drive automation and digitization initiatives that improve usability, compliance, and system performance.
- Partner with IT and Veeva administrators to maintain robust, compliant change control processes.
Quality & Regulatory Compliance
- Ensure all computerized systems maintain compliance with 21 CFR Part 11, EU Annex 11, GxP principles, and global data integrity expectations.
- Author, revise, and own Quality System policies and procedures related to electronic systems and validation.
- Represent Quality during internal audits, external regulatory inspections, and vendor assessments.
- Lead timely remediation, effectiveness checks, and continuous improvement initiatives.
- Provide oversight and trending for Quality Events related to system performance or compliance.
Required Qualifications
- Bachelor's degree in a relevant scientific or technical discipline.
- 8+ years of experience in the life sciences industry with strong GxP system experience.
- Extensive leadership experience in cross functional implementation and validation of GxP computerized systems.
- Deep expertise with Veeva Vault Quality Suite (QMS, Docs, Training, etc.).
- Strong knowledge of global regulatory expectations and data integrity frameworks.
- Demonstrated ability to lead enterprise programs, influence stakeholders, and drive compliant decision making.
Preferred Qualifications
- Expertise with SaaS/cloud architectures and database compliance expectations.
- Understanding of clinical data collection technologies and supporting data processes.
- Familiarity with SDLC, Agile methodologies, CSV vs. CSA principles and automated testing platforms.
- Experience developing and interpreting Quality metrics such as KPIs and KQIs.
- Excellent communication skills with the ability to collaborate, negotiate, and influence at all organizational levels.
Work Location and Conditions
- At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan and Tennessee.
- You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested, which may include travel by air, driving or public transportation.
- You must have access to work in setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communication via video conference, etc.) at your remote location.
About Amylyx Pharmaceuticals
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
51 - 200 Employees
Headquarters location
Cambridge, MA, US
Year founded
2013