Insight Global · 5 days ago
Pharmaceutical Quality Systems & Operational Excellence Manager
Richmond, VA
Full-time
Hybrid
Senior Level, Lead/Staff
$120K/yr - $135K/yr
8+ years expInsight Global is seeking a permanent Quality Systems & Operational Excellence Manager for one of their specialty pharmaceutical clients in Richmond, VA. This role is essential for establishing and maintaining Quality Systems while driving a culture of quality and involves creating strategic plans with cross-functional stakeholders to improve compliance and reduce risk in the Pharmaceutical Quality System.
EmploymentHuman ResourcesRecruitingSales
Hiring Manager
Catherine Towers
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
Participates in 3rd party validation planning meetings and communicates key information to stakeholders as related to IT systems
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
Utilize continuous improvement methodology and deployment across functions to improve processes. This includes Lean Six-Sigma methodologies and project management
Assist in providing support for all GxP changes and additions to SOP, Work Instruction, specifications and like controlled documents
Qualification
Required
Bachelor's Degree in a relative scientific field
Minimum of 8 years of quality control and quality assurance experience within the pharmaceutical industry
Extensive experience with 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
Insight Global provides top talent and staffing solutions that help job seekers find careers in healthcare, finance, IT, and government.
1001-5000 employees
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 StageTotal Funding
unknown2010-07-01Acquired
Leadership Team
Jared Streppa
President Of Company’s Technology Division
Recent News
Maryland Daily Record
2025-09-26
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