Quality Systems & Compliance Manager jobs in United States
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Insight Global · 4 days ago

Quality Systems & Compliance Manager

Insight Global is seeking a permanent Quality Systems & Compliance Manager for one of their specialty pharmaceutical clients in Richmond, VA. This role is crucial in establishing and maintaining Quality Systems and driving a culture of quality, while also supporting compliance and risk reduction in the Pharmaceutical Quality System.

EmploymentHuman ResourcesRecruitingSales
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H1B Sponsor Likelynote
Hiring Manager
Catherine Towers
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Responsibilities

Cross-functional influence to create strategic plans to ensure establishment and lifecycle management of a compliant Pharmaceutical Quality System (PQS) which contains over 100 cross-functional processes
Oversee and action GxP IT systems change controls and validation documents such as quality assurance plans, test scripts and other documents as required; also supports technical transfer, testing, qualification and validation
Write, review and/or approve validation protocols and reports
Provides GxP IT support for reviewing and approving IT change controls quality assurance plans and other validation records
Act as a process owner for Quality Management System processes
Act as IT system Superuser (if the process uses an IT system) and able to support and advise on IT system changes and carry out execution of test scripts when required
Provide direct oversight and influence for the PQS processes (where the Quality Systems team does not have Process Ownership) and work with stakeholders to identify and rectify compliance gaps and improvements

Qualification

Pharmaceutical Quality SystemsComputer System ValidationVeevaTrackwiseQuality AssuranceDeviation InvestigationsCAPA ManagementRisk AssessmentsCustomer ComplaintsCross-functional Influence

Required

Bachelor's Degree in a related scientific field
Minimum of 8 years of pharmaceutical or medical device quality control and quality assurance work experience
Extensive experience with either Veeva or Trackwise
Computer System Validation (CSV) experience
Experience with customer complaints, deviation investigations, risk assessments and CAPAs

Benefits

Relocation assistance
20 days of vacation plus floating holidays and sick leave
401(k) and profit sharing plan
Tuition reimbursement
Comprehensive medical, dental, vision, life and disability coverage
HSA, FSA, and DCFSA account options
401k retirement account access with employer matching
Paid sick leave and/or other paid time off as provided by applicable law

Company

Insight Global

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Insight Global provides top talent and staffing solutions that help job seekers find careers in healthcare, finance, IT, and government.

H1B Sponsorship

Insight Global has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (281)
2024 (164)
2023 (75)
2022 (17)
2021 (3)
2020 (2)

Funding

Current Stage
Late Stage
Total Funding
unknown
2010-07-01Acquired

Leadership Team

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Jared Streppa
President Of Company’s Technology Division
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Company data provided by crunchbase