Lead GxP internal audits and external audits including completing audit reports and follow-up on corrective actions. * Maintain the internal/external audit schedules. * Assure GMP/GxP compliance with ...
Lead GxP internal audits and external audits including completing audit reports and follow-up on corrective actions. * Maintain the internal/external audit schedules. * Assure GMP/GxP compliance with ...
Lead enterprise compliance risk management by proactively identifying, assessing, and mitigating regulatory and quality risks while advising executive leadership on strategic compliance decisions.
Lead enterprise compliance risk management by proactively identifying, assessing, and mitigating regulatory and quality risks while advising executive leadership on strategic compliance decisions.
Lead, develop, and mentor the team, providing strategic direction and ensuring effective execution ... Experience providing Quality oversight for enterprise GxP platforms, cloud/SaaS applications ...
Lead, develop, and mentor the team, providing strategic direction and ensuring effective execution ... Experience providing Quality oversight for enterprise GxP platforms, cloud/SaaS applications ...
Lead enterprise validation initiatives across multiple concurrent projects * Oversee development ... GxP computerized systems and validation * 3+ years in a leadership or program management role
Quick apply
Lead enterprise validation initiatives across multiple concurrent projects * Oversee development ... GxP computerized systems and validation * 3+ years in a leadership or program management role
The Senior Manager, Veeva Regulatory & Data serves as the technology lead for enterprise ... Scholar Rock has established a strong foundation of GxP applications and technology capabilities ...
The Senior Manager, Veeva Regulatory & Data serves as the technology lead for enterprise ... Scholar Rock has established a strong foundation of GxP applications and technology capabilities ...
Lead enterprise validation initiatives across multiple concurrent projects * Oversee development ... GxP computerized systems and validation * 3+ years in a leadership or program management role
Lead enterprise validation initiatives across multiple concurrent projects * Oversee development ... GxP computerized systems and validation * 3+ years in a leadership or program management role
Ensure QMS and GxP digital systems remain in a validated state through appropriate validation ... Lead continuous improvement initiatives across quality systems and processes, identifying ...
Ensure QMS and GxP digital systems remain in a validated state through appropriate validation ... Lead continuous improvement initiatives across quality systems and processes, identifying ...
Ensure QMS and GxP digital systems remain in a validated state through appropriate validation ... Lead continuous improvement initiatives across quality systems and processes, identifying ...
Ensure QMS and GxP digital systems remain in a validated state through appropriate validation ... Lead continuous improvement initiatives across quality systems and processes, identifying ...
Ensure QMS and GxP digital systems remain in a validated state through appropriate validation ... Lead continuous improvement initiatives across quality systems and processes, identifying ...
Ensure QMS and GxP digital systems remain in a validated state through appropriate validation ... Lead continuous improvement initiatives across quality systems and processes, identifying ...
Lead and own global GxP compliance and auditing programs. * Serve as the Global Business Process and System Owner for Compliance and Auditing. * Define, implement, and maintain compliance processes ...
Lead and own global GxP compliance and auditing programs. * Serve as the Global Business Process and System Owner for Compliance and Auditing. * Define, implement, and maintain compliance processes ...
The Senior Manager, Veeva Regulatory & Data serves as the technology lead for enterprise ... Scholar Rock has established a strong foundation of GxP applications and technology capabilities ...
The Senior Manager, Veeva Regulatory & Data serves as the technology lead for enterprise ... Scholar Rock has established a strong foundation of GxP applications and technology capabilities ...
Ensure QMS and GxP digital systems remain in a validated state through appropriate validation ... Lead continuous improvement initiatives across quality systems and processes, identifying ...
Quick apply
Ensure QMS and GxP digital systems remain in a validated state through appropriate validation ... Lead continuous improvement initiatives across quality systems and processes, identifying ...
VP, Regulatory Affairs & Quality - Oncology (GxP) (Northern)
Eastern, KY ยท On-site
$110K - $146K/yr
Pliant Therapeutics, Inc. in South San Francisco seeks a strategic Vice President, Regulatory Affairs & Quality (GxP) to lead regulatory and quality efforts across early oncology programs. The role ...
VP, Regulatory Affairs & Quality - Oncology (GxP) (Northern)
Eastern, KY ยท On-site
$110K - $146K/yr
Pliant Therapeutics, Inc. in South San Francisco seeks a strategic Vice President, Regulatory Affairs & Quality (GxP) to lead regulatory and quality efforts across early oncology programs. The role ...
Lead Quality governance and implementation of Artificial Intelligence (AI) and emerging ... Experience providing Quality oversight for enterprise GxP platforms, cloud/SaaS applications ...
Lead Quality governance and implementation of Artificial Intelligence (AI) and emerging ... Experience providing Quality oversight for enterprise GxP platforms, cloud/SaaS applications ...
GXP Project Manager
San Francisco, CA ยท On-site
GXP Project Manager Location: Bay Area CA Type: Contract Role Summary The driving force behind ... Lead projects from requirements definition through deployment, identifying schedules, scopes ...
GXP Project Manager
San Francisco, CA ยท On-site
GXP Project Manager Location: Bay Area CA Type: Contract Role Summary The driving force behind ... Lead projects from requirements definition through deployment, identifying schedules, scopes ...
Lead GxP internal audits and external audits including completing audit reports and follow-up on corrective actions. * Maintain the internal/external audit schedules. * Assure GMP/GxP compliance with ...
Lead GxP internal audits and external audits including completing audit reports and follow-up on corrective actions. * Maintain the internal/external audit schedules. * Assure GMP/GxP compliance with ...
Lead and own global GxP compliance and auditing programs. * Serve as the Global Business Process and System Owner for Compliance and Auditing. * Define, implement, and maintain compliance processes ...
Lead and own global GxP compliance and auditing programs. * Serve as the Global Business Process and System Owner for Compliance and Auditing. * Define, implement, and maintain compliance processes ...
Sr Director, QA- GxP Systems
Needham, MA ยท On-site
Lead qualification, risk assessment, and ongoing oversight of a diverse ecosystem of internal and ... Deliver GxP systems training and drive continuous improvement initiatives, trend analysis, and ...
Sr Director, QA- GxP Systems
Needham, MA ยท On-site
Lead qualification, risk assessment, and ongoing oversight of a diverse ecosystem of internal and ... Deliver GxP systems training and drive continuous improvement initiatives, trend analysis, and ...
Maintain current knowledge of applicable GxP requirements, regulatory expectations, industry practices, and learning methodologies, and recommend and implement opportunities to improve the ...
Maintain current knowledge of applicable GxP requirements, regulatory expectations, industry practices, and learning methodologies, and recommend and implement opportunities to improve the ...
GXP Sales Account Executive with Security Clearance
Reston, VA ยท On-site
$132K - $226K/yr
GXP commercially, out of the box, supports development of the most advanced geospatial intelligence ... Lead the full sales cycle: prospecting, qualification, requirements gathering, solution positioning ...
GXP Sales Account Executive with Security Clearance
Reston, VA ยท On-site
$132K - $226K/yr
GXP commercially, out of the box, supports development of the most advanced geospatial intelligence ... Lead the full sales cycle: prospecting, qualification, requirements gathering, solution positioning ...
Gxp Lead information
See salary details
$11.78 - $14.79
3% of jobs
$14.79 - $17.81
16% of jobs
$18.60 is the 25th percentile. Wages below this are outliers.
$17.81 - $20.83
22% of jobs
The median wage is $22.25 / hr.
$20.83 - $23.84
18% of jobs
$26.76 is the 75th percentile. Wages above this are outliers.
$23.84 - $26.86
16% of jobs
$26.86 - $29.87
12% of jobs
$29.87 - $32.89
6% of jobs
$32.89 - $35.90
5% of jobs
$35.90 - $38.92
1% of jobs
$38.92 - $41.94
0% of jobs
$41.94 - $44.95
0% of jobs
$11
$25
$44
How much do gxp lead jobs pay per hour?
What are popular job titles related to Gxp Lead jobs?
For Gxp Lead jobs, the most frequently searched job titles are:

Senior QA Manager, GMP GxP Auditing & Vendor Management
Redwood City, CA โข Remote
Full-time
Posted 27 days ago
Job description
The Opportunity:
Lead GxP internal audits and external audits including completing audit reports and follow-up on corrective actions.
Maintain the internal/external audit schedules.
Assure GMP/GxP compliance with suppliers.
Oversight of all aspects of GxP vendor / supplier program management to ensure compliance with GxP regulations and RevMed internal standards.
Demonstrate the ability to multi-tack. Prioritize work and independently solve problems.
Collaborate with vendors and internal teams to draft and complete Quality Agreements.
Perform Risk Assessments, qualifications, and monitor Suppliers/CMOs.
Collaborate with cross-functional teams and represent Quality Vendor Management at meetings.
Create and implement any tools to improve compliance, consistency, and efficiency for GMP/GXP auditing and Vendor management.
Provide support preparation of anticipated regulatory inspections (including those at contracted organizations), and partner audits with cross-functional teams.
Maintain supplier management program, ensuring requirements, plans, processes, metrics, and tracking system for GxP suppliers are established and followed.
Responsible for qualifications of GMP suppliers including performing audits, generation of audit reports, and follow- up with suppliers for addressing observations from audits.
Negotiate, draft, and manage quality technical agreements (QTA) and/or contracts with suppliers, ensuring alignment with internal standards, regulations, and industry standards.
Lead meetings for alignment, communication, and resolution of issues.
Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to RevMed procedures.
Lead supplier performance metrics to monitor the health of systems, drive proactive identification of risk, and mitigate compliance issues.
Generate slides and presentations for reviews and communication to stakeholders.
Update Veeva, track KPIs, assure GxP audits.
Maintain the approved GxP supplier list and the annual audit schedules.
Required Skills, Experience and Education:
BA/BS degree in Biological Sciences, Chemistry, or related field and/or equivalent experience and education.
Minimum experience required 8+ years of pharmaceutical/Biotech experience with a minimum of 5+ years' GMP Lead Auditor experience.
5 years of QTA and Supplier Quality Management experience.
ASQ Certified Quality Auditor or equivalent certifications.
Excellent leadership and people management/development skills as required.
Direct experience working with Quality System electronic databases.
Strong written and oral communication skills as well as negotiation skills.
Ability to travel occasionally (up to 25%) to perform external audits.
Flexible, and an ability to navigate through rapid growth and adapt to rapid change.
Proficiency with Microsoft Office (Excel, Outlook, PowerPoint, Word) required.
Preferred Skills:
Direct experience writing and negotiating Quality Agreements with Suppliers and partners.
Vendor Qualification and risk assessment experience.
Strategic thinking, and project management skills.
Extensive experience leading audits, evaluating CAPA and developing presentations analyzing complex data.
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