Quality Assurance Manager at International Livestock Research Institute (ILRI)

The Program

ILRI is in the process of developing a Contract Research Organization (CRO) arm to provide services to internal and external research projects utilizing its animal research facilities. To ensure the delivery of efficient and high-quality research in line with compliance (VICH GCP) and timelines, ILRI is looking for an experienced person in charge of quality assurance and compliance of all CRO activities.

Key Responsibilities:

• Ensure compliance to relevant guidelines, Controlled Documents, and study plans/protocols by performing:
  • Study specific audits on the critical phases identified for a study
  • Audits on study plans/protocols and final study reports, including amendments
  • System/facility and process audits as per audit plan.
  • Directed audits as requested and delegated by Head of Quality Assurance
• Perform Subcontractor and Outsourced Company evaluations and audits as requested and delegated
• Prepare and issue audit reports and document findings, observations, and critical findings
• Perform reviews of Controlled Documents.
• Develop, recommend, and monitor corrective and preventive actions and communicate to relevant management
• Manage Controlled Document deviations and Change Control Plans
• Manage the Master Schedules
• Support Sponsor audits and Regulatory inspections performed at ILRI
• Support in the training of personnel in GLP and GCP principles and of Quality Assurance SOPs
• Maintain internal training compliance
• Manage the department’s compliance to accreditation, legal and regulatory requirements
• Manage reporting employees with the intent to promote a culture that reflects the organization’s values, encourages good performance and rewards productivity
• Observe the correct reporting, remedial and corrective actions to be followed by following set instructions and procedures to report and correct any non-conformance issues.
• Execute other tasks and activities as delegated by the supervisor
• Work in close collaboration with ILRI’s EOHS (Environmental, Occupational Health & Safety) department

Requirements

• MSc. or equivalent qualification in biological or natural sciences; and
• Sound knowledge of GLP and GCP quality systems
• At least 5 years’ relevant experience
• Expertise in animal health, animal welfare, biosecurity, bio-safety issues, and the 3Rs (Refine, Replace and Reduce) concept associated with animal health research.