Overview
On Site
USD 50.00 - 55.00 per hour
Contract - Independent
Skills
SAP
SAP ERP
Data Migration
Migration
Reporting
Software Development Methodology
Regression Testing
SAP HANA
Scrum
GxP
Auditing
Inspection
Test Plans
Root Cause Analysis
Corrective And Preventive Action
Data Integrity
Drive Testing
Agile
Documentation
Mentorship
Partnership
Regulatory Compliance
Privacy
Marketing
Job Details
Location: Lansdale, PA
Description: Job Title:
GxP Compliance Lead
Location:
West Point, PA (Hybrid - 3 days onsite per week)
Employment Type:
Contract (12 months with possible extension)
Compensation:
50-55/hr W2 only - Must be able to accept work without sponsorship now or in the future.
About the Role:
We are seeking a GxP Compliance Lead to provide quality oversight for GxP computerized systems and ensure compliance with company policies, procedures, and regulatory expectations. This role will support audit and inspection activities, remediation efforts, and governance for SDLC deliverables using a risk-based approach.
Minimum Qualifications:
By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
Contact:
This job and many more are available through The Judge Group. Please apply with us today!
Description: Job Title:
GxP Compliance Lead
Location:
West Point, PA (Hybrid - 3 days onsite per week)
Employment Type:
Contract (12 months with possible extension)
Compensation:
50-55/hr W2 only - Must be able to accept work without sponsorship now or in the future.
About the Role:
We are seeking a GxP Compliance Lead to provide quality oversight for GxP computerized systems and ensure compliance with company policies, procedures, and regulatory expectations. This role will support audit and inspection activities, remediation efforts, and governance for SDLC deliverables using a risk-based approach.
Minimum Qualifications:
- Proven experience as a GxP Compliance Lead in a regulated environment.
- Hands-on experience with SAP S/4HANA or ECC for GxP functionality, including data migration, qualification of migration tools, and interface/report validation.
- Strong knowledge of Computer System Assurance (CSA) framework and risk-based validation strategies.
- Expertise in SDLC deliverables, functional/regression testing, and CAPA development.
- Ability to lead root cause analysis and investigations for IT system incidents.
- Deep understanding of Data Integrity principles and remediation activities.
- Experience with S/4HANA implementation projects.
- Familiarity with Agile methodologies and participation in Scrum ceremonies.
- Provide quality oversight for GxP computerized systems across programs.
- Own audit and inspection support and remediation activities.
- Define and approve risk-based validation strategies and test plans.
- Lead root cause analysis for IT system incidents and drive CAPA development.
- Serve as subject matter expert on Data Integrity and ensure lasting controls.
- Drive testing strategy and quality practices within Agile teams.
- Review and approve IT system change requests for compliance and traceability.
- Authorize/revise SOPs, work instructions, and quality documentation.
- Mentor quality staff and foster collaborative, cross-functional partnerships.
- Lead meetings to resolve compliance issues and ensure timely resolution.
By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
Contact:
This job and many more are available through The Judge Group. Please apply with us today!
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