Medical Laboratory Quality Assurance Manager Job Vacancy in Ntchisi, Malawi – Healthcare Diagnostics

Job Description

Position: Medical Laboratory Quality Assurance Manager

Company: Roche Diagnostics

Location: Ntchisi, Malawi

Experience: Minimum 7 years in a clinical laboratory quality management role, with at least 3 years in a supervisory capacity.

Education: Master’s degree in Medical Laboratory Science, Clinical Pathology, Biomedical Sciences, or a related field. Certification as a Quality Manager (e.g., ASQ CMQ/OE, ISO 15189 Lead Auditor) is mandatory.

Employment Type: Full-time

Industry: Healthcare Diagnostics

Department: Quality Assurance & Compliance

Vacancies:1

Company Overview

Roche Diagnostics is a global pioneer in pharmaceuticals and diagnostics, focused on advancing science to improve people’s lives. We are a leader in the field of in-vitro diagnostics, developing innovative tests and digital solutions that provide critical insights for healthcare professionals and patients. Our commitment to quality, accuracy, and reliability is at the core of everything we do. In Malawi, we are dedicated to strengthening the national healthcare infrastructure by ensuring diagnostic laboratories operate at the highest international standards. This role is central to our mission of providing accurate, timely, and reliable diagnostic results that are crucial for patient care and public health outcomes across the region. We offer a dynamic and supportive environment where professionals can grow while making a tangible impact on community health.

Job Overview

We are seeking a highly experienced and dedicated Medical Laboratory Quality Assurance Manager to lead our quality management system at our diagnostic facility in Ntchisi. This is a critical leadership role responsible for ensuring all laboratory processes, from sample collection to result reporting, comply with national regulations and international standards such as ISO 15189 and WHO guidelines. The successful candidate will be the cornerstone of our laboratory’s credibility, implementing robust quality control programs, managing audits, and fostering a culture of continuous improvement. This position offers a unique career opportunity in Malawi to work with cutting-edge diagnostic technology while directly contributing to improved healthcare outcomes. For more jobs in Malawi and career resources, visit our partner site at https://malawijobsearch.com.

Key Responsibilities

• Develop, implement, and maintain the laboratory’s comprehensive Quality Management System (QMS) in full compliance with ISO 15189 standards and Malawi Ministry of Health requirements.
• Lead internal audits and manage the preparation for and response to external accreditation audits from bodies like the South African National Accreditation System (SANAS) or other recognized entities.
• Oversee all quality control procedures, including the evaluation of new reagents, instruments, and test methodologies before implementation.
• Investigate non-conformances, customer complaints, and adverse incidents; implement corrective and preventive actions (CAPA) and monitor their effectiveness.
• Manage document control for all standard operating procedures (SOPs), policies, and quality records, ensuring they are current, accessible, and properly archived.
• Coordinate proficiency testing (PT) and external quality assessment (EQA) schemes, analyzing results and leading improvement initiatives for any suboptimal performance.
• Provide ongoing training and mentorship to laboratory staff on quality principles, safety protocols, and Good Laboratory Practice (GLP).
• Prepare and present regular quality metrics and reports to senior management, highlighting trends, risks, and opportunities for improvement.
• Liaise with regulatory authorities and represent the laboratory in matters pertaining to quality and accreditation.

Required Skills

• Expert knowledge of international quality standards for medical laboratories, specifically ISO 15189, ISO 17025, and CLSI guidelines.
• Proven expertise in root cause analysis, risk management methodologies, and statistical process control relevant to laboratory medicine.
• Exceptional leadership, communication, and interpersonal skills to influence and train a diverse team of laboratory professionals.
• Strong analytical and problem-solving abilities with a meticulous attention to detail.
• High proficiency in laboratory information management systems (LIMS) and quality management software.
• Excellent report-writing and presentation skills.
• Ability to work independently, manage multiple priorities, and drive projects to completion in a fast-paced environment.

Education

A Master’s degree in Medical Laboratory Science, Clinical Pathology, Biomedical Sciences, or a closely related field is required. The candidate must hold a current and valid professional license to practice as a Medical Laboratory Scientist in Malawi. Mandatory certification as a Quality Manager (e.g., ASQ Certified Manager of Quality/Organizational Excellence, ISO 15189 Lead Auditor) is non-negotiable. Additional training in laboratory safety (biosafety, chemical safety) and project management is highly desirable.

Experience

A minimum of seven (7) years of progressive experience working in a clinical or diagnostic laboratory environment is required. At least three (3) of those years must be in a dedicated quality management or quality assurance role with supervisory responsibilities. Demonstrated hands-on experience in leading a laboratory through a successful ISO 15189 accreditation process is a significant advantage. Experience in a high-throughput reference laboratory or a multinational diagnostic organization is preferred. This represents a premier job vacancy in Malawi for a seasoned quality professional.

Benefits

• Competitive salary package with performance-based bonuses.
• Comprehensive health, dental, and life insurance for employee and dependents.
• Generous annual leave and public holiday allowance.
• Continuous professional development allowance for conferences and certifications.
• Pension contribution scheme.
• Relocation assistance (if applicable).
• Access to state-of-the-art diagnostic equipment and digital tools.
• Opportunities for international training and career advancement within the Roche global network.

Training

• Extensive onboarding program covering Roche’s global quality policies and local SOPs.
• Specialized training on advanced quality management software and data analytics tools.
• Sponsorship for advanced quality and leadership courses.
• Regular updates on changes to international standards and regulatory requirements.
• Cross-functional project management training.

Working Environment

You will work in a modern, well-equipped diagnostic laboratory in Ntchisi, adhering to the highest standards of biosafety and biosecurity. The role involves a combination of desk-based quality system management and hands-on laboratory oversight. You will lead a team of dedicated professionals in a collaborative, evidence-based culture that values precision, integrity, and patient impact. We promote a healthy work-life balance and provide the tools necessary for professional excellence. This is a key role in advancing employment in Malawi within the critical healthcare diagnostics sector.

Application Process

Interested and qualified candidates are invited to submit their application, including a detailed CV and a cover letter highlighting their experience with quality management systems and accreditation processes, through the official Roche Careers portal. Only shortlisted candidates will be contacted for interviews. The selection process may include practical assessments and panel interviews. For other hiring in Malawi opportunities across various sectors, you can explore https://www.zambiajobssearch.com/.

Equal Opportunity Statement

Roche Diagnostics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment in Malawi without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We strongly encourage applications from all backgrounds to apply for this and other Malawi jobs.