CRO Quality Assurance Manager

  • Nairobi, Kenya
  • Animal and Human Health

The International Livestock Research Institute (ILRI) seeks to recruit a Quality Assurance Officer to maintain a Quality Management System (QMS) thus ensuring GLP/GCP accreditation under ILRI’s newly developed Contract Research Organization (CRO) unit.

ILRI works to improve food and nutritional security and reduce poverty in developing countries through research for efficient, safe and sustainable use of livestock. It is the only one of 15 CGIAR research centres dedicated entirely to animal agriculture research for the developing world. Co-hosted by Kenya and Ethiopia, it has regional or country offices and projects in East, South and Southeast Asia as well as Central, East, Southern and West Africa. www.ilri.org

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 time lines, 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.

Terms of Appointment

This position is at job level HG 15. The position is a 3-year contract, renewable subject to satisfactory performance and availability of funding. ILRI offers a competitive salary and benefits package which includes; pension, medical and other insurances

How to apply: Applicants should send a cover letter and CV explaining their interest in the position, what they can bring to the job and the names and addresses (including telephone and email) of three referees who are knowledgeable about the candidate’s professional qualifications and work experience to the Director, People and Organizational Development by clicking on the "Apply Now" tab above before 31 January 2020. The position title and reference number REF: CRO/02/2020 should be clearly marked on the subject line of the cover letter.

We thank all applicants for their interest in working for ILRI. Due to the volume of applications, only shortlisted candidates will be contacted.

ILRI does not charge a fee at any stage of the recruitment process (application, interview meeting, processing or training). ILRI also does not concern itself with information on applicants' bank accounts.

To find out more about ILRI visit our websites at http://www.ilri.org

ILRI is an equal opportunity employer.

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