Senior CQA Manager

7 days ago

Cape Town, Western Cape, South Africa Somewhere Full time US$54 000 - US$90 000 per year
Role: Senior CQA Manager (Clinical Quality Assurance) 

Salary Range: $4.500 to 7,500 Usd   Monthly based on Experience 

Type of contract: Independent contractor Agreement 

Working Hours: Est M-F

100% Remote  - Open for South Africa

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 that clinical  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 4 years 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
 

 

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