Senior CQA Manager (Clinical Quality Assurance)
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Job Location:
Philippines - Philippines
Monthly Salary:
$ 4 - 7500
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Role: Senior CQA Manager (Clinical Quality Assurance)
Salary Range: $4.000 to 7500 Usd based on Experience
Type of contract: Independent contractor Agreement
Working Hours: Est M-F
100% Remote - The Philippines
About the Company:
This client is a growing Pharmaceutical Company based in North America and they need someone who adapts to Central east or pacific time zone.
About the Position:
This position will be responsible for ensuring the sponsor(s)Quality oversight activity of clinical programs .
Ensure thatclinical studies have been implemented and appropriated to uphold the rights safety and wellbeing of each subject and that the oversight activity is being effectively monitored and remains adequate to support good clinical practices throughout the conduct of research being performed by or own behalf of the sponsor.
The ideal candidate must be comfortable working independently managing interactions with and between team members both internally and externally leading process improvement initiatives across the Clinical teams.
GCP auditors will be considered but we prefer someone who can provide solutions and process improvements. Senior level quality assurance with sponsor team background.
Responsibilities
- Assist the Clinical Development organization in establishing procedures to support a risk-based approach to oversight of clinical trials using principles of quality by design and quality risk management
- Participate on cross-functional team meetings as the Clinical Quality Assurance Subject Matter Expert (SME)
- Proactively identify potential quality issues/discrepancies and work with Management to effectively resolve in a compliant and timely manner
- Provide Clinical Quality support for critical quality issues protocol deviations investigations root causes and CAPAs
- Develop a risk-based audit program to conduct effective audits of internal processes investigator sites and vendors that support development activities
- Establish clinical quality procedures and tools in support of audit and compliance activities
- Collaborate with key stakeholders in development and implementation of internal and external GCP audit plans
- Assist in the development implementation and maintenance of training and compliance programs:
- Build the Clinical Quality Assurance and Compliance function and infrastructure
- Lead the development and delivery of GCP and Inspection Readiness training for the Clinical organization.
- Lead the development and implementation of processes and tools to support teams and functions in being inspection-ready.
Requirements
To succeed in this position the incumbent must have extensive knowledge and experience with Good Clinical Practices ICH E6 Data Integrity Clinical Quality Assurance Monitoring/Auditing BIMO Inspection Readiness and Trial Master File expertise.
- A minimum of 4years relevant GCP experience in pharma/biotech company working within quality systems and regulated GCP/ICH environments
- Experience leading and facilitating inspection readiness activities and hosting FDA and/or other regulatory agency inspections
- Experience managing internal and external audits
- Strong understanding of GCPs FDA and ICH regulatory standards/guidance documents
Required Experience:
Manager
Key Skills
- Continuous Integration
- Quality Assurance
- FDA Regulations
- Root cause Analysis
- TFS
- Food Processing
- ICH Q10
- Jira
- Software Testing
- Quality Management
- Selenium
- Github
About Company
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