QMS Implementation Lead

Remote • Posted 10 hours ago • Updated 9 hours ago

Contract Corp To Corp

Contract W2

Contract Independent

No Travel Required

Remote

Depends on Experience

Resourcesoft, Inc.

Fitment

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Job Details

Skills

SDLC
21 CFR Part 11
URS
Change Control
CAPA
QMS
Life Sciences
CSV
GxP
GAMP 5
EU Annex 11
Quality Management System
ICH E6(R3)
ALCOA+
AI Validation
Machine Learning Validation
Pharma Compliance
Traceability Matrix

Summary

Requirements

8 or more years of experience in GxP quality management and QMS architecture for life sciences.
Proficiency in GAMP 5, 21 CFR Part 11, and EU Annex 11 compliance standards.
Experience with building Quality Management Systems from zero within regulated SaaS or technology environments.
Experience in Computer System Validation (CSV) for cloud-hosted and configurable software platforms.
Experience with CAPA remediation, deviation SOPs, and formal audit defense for pharma sponsors.
Experience in validating machine learning systems and AI agentic workflows in clinical data contexts.
Excellent verbal and written communication skills.

Responsibilities

Author foundational Quality Manuals and SOPs for CAPA, deviations, and GxP SDLC processes.
Lead end-to-end CAPA remediation by tracking audit findings and delivering formal root cause responses.
Translate complex AI technical controls into GxP-compliant documentation artifacts and validation packages.
Execute validation protocols, user requirement specifications, and requirements traceability matrices for new deployments.
Serve as the primary subject matter expert during vendor qualification audits by defending internal documentation.
Determine compliance scoping for clinical data workflows and AI model versioning change impact assessments.
Partner with engineering teams to integrate quality standards into sprint-based software delivery cycles.

Founded in 1999, Resourcesoft, Inc. is a leading Technology Consulting and Professional Services organization. Headquartered in Marlborough, MA, the company serves the technology needs of its clients nationwide. Resourcesoft has often been recognized by prominent rating agencies for its exemplary growth and stability. With over two decades of industry experience, the Company has evolved as a front runner in enabling project optimization. We partner with leading organizations to provide technology solutions within the financial, insurance, education, government, publishing, healthcare and pharmaceutical domains. We take pride in mentoring a workforce that is well positioned to respond to the emerging IT trends and needs. With the employees at the crux of every business endeavor, our success is driven by our expertise in pairing the right talent with the best jobs in the technology sector. We forge long term, personalized relationships with our employees to advance their career to the next level. We engage them in technology centric client projects that provide opportunities for them to evolve, innovate and deliver world class products and services. Our career opportunities offer challenging assignments and exposure to emerging and cutting edge technologies. We are committed to providing our employees with the tools necessary to accelerate their career progression, while maintaining a healthy, work-life balance. We are deeply committed to providing a workplace ambience that is both challenging and fulfilling.

Resourcesoft is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

For more information about Resourcesoft and our services, please visit our website.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10117734
Position Id: 20744-27990-
Posted 10 hours ago

Company Info

About Resourcesoft, Inc.

Founded in 1999, Resourcesoft, Inc. is a leading Technology Consulting and Professional Services organization. Headquartered in Marlborough, MA, the company serves the technology needs of its clients nationwide. Resourcesoft has often been recognized by prominent rating agencies for its exemplary growth and stability. With over two decades of industry experience, the company has evolved as a front runner in enabling project optimization. We partner with leading organizations to provide technology solutions within the financial, insurance, education, government, publishing, healthcare and pharmaceutical domains. We take pride in mentoring a workforce that is well positioned to respond to the emerging IT trends and needs. With the employees at the crux of every business endeavor, our success is driven by our expertise in pairing the right talent with the best jobs in the technology sector. We forge long term, personalized relationships with our employees to advance their career to the next level. We engage them in technology centric client projects that provide opportunities for them to evolve, innovate and deliver world class products and services. Our career opportunities offer challenging assignments and exposure to emerging and cutting edge technologies. We are committed to providing our employees with the tools necessary to accelerate their career progression, while maintaining a healthy, work-life balance. We are deeply committed to providing a workplace ambience that is both challenging and fulfilling.

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