Quality Assurance

**QUALITY ASSURANCE & QUALITY CONTROL MANAGER**

**FIVE (5) YEAR FIXED-TERM CONTRACT**

**WOODSTOCK**

The Desmond Tutu Health Foundation (DTHF) is a registered non-profit organisation focused on the pursuit of excellence in research, treatment, training and prevention of HIV and related infections in Southern Africa.

We have fantastic job opportunities across our businesses for talented people wanting to realize their full potential. Could that be you? If so, we invite you to explore the possibility of joining us to play your part in Desmond Tutu Health Foundations exciting future.

The Desmond Tutu Health Foundation is currently seeking an experienced QA/QC Manager to carry out quality assurance (QA) and quality control (QC), including internal monitoring and assessing study team compliance against required study procedures; Good Clinical Practice & Good Documentation Practices, to verify that all research guidelines and regulations are adhered to. Identify non-compliance and quality control deficiencies; communicate findings to staff and develop in-house training (or source appropriate external training) to mitigate risk and improve overall data quality and patient safety.

**Minimum Requirements**:

- Degree in Health Sciences
- A minimum of five (5) years relevant clinical research experience
- A minimum of two (2) years experience in quality control processes, one of which should be managing the QA process
- A minimum of three 2-3 years experience in a leadership/managerial capacity
- Experience in Clinical Operations Research
- Strong knowledge and experience in establishing QA Manager protocol and standards
- Strong knowledge of GCP guidelines and clinical trial processes; including valid GCP certificate
- Valid code 08 drivers license
- Strong verbal and written proficiency in English
- Excellent computer literacy, including advanced Excel skills
- Solid organising and planning skills
- Ability to work with a diverse group of people
- Excellent stakeholder relationship management
- Lateral creative and critical thinking, problem solving, and detail orientated
- Decision making & analytical skills
- Adaptive to change
- Willing to travel to sites, locally

**Advantageous**:

- Knowledge of DAIDS Clinical Quality Management Plan (CQMP) Policy
- Strong verbal and written proficiency in isiXhosa and/or Afrikaans

**Responsibilities**:

- Provide input on CRS clinical quality management plan development and implementation, in line with NIH DAIDS Clinical Quality Management Plan
- Review all CRSs CQMP, Policy and submit annually to DAIDS
- Develop Quality Control (QC) and Quality Assurance (QA) checklists per protocol/site
- Plan internal monitoring visit and notify site of Participant Identification (PID) list, as per Sponsor/Regulatory ad-hoc notifications.
- Perform medical procedure reviews of records and critically analyse protocol adherence, Study Specific Plans and standard operating procedures.
- Review medical records to ensure, adequate safety reporting and identify protocol deviations
- Conduct 6-monthly reviews of regulatory files
- Ensure that all documents that require ethics and regulatory review are submitted timeously and have approvals in place
- Establish and maintain a good rapport with all Clinical Research Site staff
- Directly manage internal monitors
- Identify staff development areas and operational deficiencies and implement corrective action and training

**Values fit: Passion Innovation Progress Integrity Respect Excellence**

Remuneration, depending on qualification and experience, is between R55,966 R65,842 pm.

**Visit the DTHF Career page to view the advert DTHF-C103 and apply**: