Pharmaceutical Quality Assurance Manager Job Vacancy in Ntchisi, Malawi – Pharmaceuticals

Job Description

Position: Pharmaceutical Quality Assurance Manager

Company: Novartis

Location: Ntchisi, Malawi

Experience: Minimum 8 years in pharmaceutical quality assurance, with at least 3 years in a managerial role

Education: Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or related field; Master’s degree or professional certification in Quality Assurance preferred

Employment Type: Full-time

Industry: Pharmaceuticals

Department: Quality Assurance

Vacancies:1

Company Overview

Novartis is a global healthcare leader committed to improving and extending people’s lives through innovative medicines and therapies. With a presence in over 140 countries, we combine cutting-edge science with digital technology to create transformative treatments in areas of great medical need. Our mission is to discover new ways to improve and extend people’s lives, and we leverage our scale and expertise to drive sustainable access to our medicines worldwide. In Malawi, Novartis has established a significant footprint, contributing to the strengthening of the local pharmaceutical sector and healthcare infrastructure. We are dedicated to upholding the highest standards of quality, safety, and efficacy in all our products and operations, ensuring that patients in Malawi and across the region receive medicines they can trust. Our commitment extends beyond manufacturing to comprehensive community health initiatives and capacity building within the local healthcare ecosystem.

As a leader in the pharmaceutical industry, Novartis fosters a culture of innovation, integrity, and inclusion. We believe that our people are our greatest asset, and we invest heavily in their development and well-being. Our operations in Malawi are integral to our African strategy, focusing on sustainable healthcare solutions and robust quality systems that meet both local regulatory requirements and international standards. We are now seeking a dedicated Pharmaceutical Quality Assurance Manager to lead our quality initiatives in Ntchisi, contributing to our mission of reimagining medicine for the people of Malawi.

Job Overview

We are seeking an experienced and detail-oriented Pharmaceutical Quality Assurance Manager to oversee all quality assurance activities at our pharmaceutical manufacturing facility in Ntchisi, Malawi. This critical leadership role ensures that all products manufactured, stored, and distributed meet the highest standards of quality, safety, and efficacy in compliance with Malawian regulatory requirements, WHO Good Manufacturing Practices (GMP), and Novartis global quality standards. The successful candidate will lead a team of quality professionals, manage the Quality Management System (QMS), and serve as the primary point of contact for regulatory inspections and quality audits.

This position offers a unique opportunity to play a pivotal role in safeguarding public health by ensuring the integrity of essential medicines in the Malawian market. The Pharmaceutical Quality Assurance Manager will be responsible for developing, implementing, and maintaining robust quality systems, conducting risk assessments, managing deviations and corrective actions, and fostering a strong quality culture throughout the organization. This role is essential for maintaining our license to operate and upholding our reputation for excellence in the pharmaceutical industry. For more Jobs in Malawi and Career Opportunities in Malawi, visit our partner site at https://malawijobsearch.com.

Key Responsibilities

• Develop, implement, and maintain the site’s Quality Management System (QMS) in alignment with Novartis global standards and local regulatory requirements.
• Lead and mentor the quality assurance team, providing guidance, training, and performance management to ensure high performance and professional development.
• Oversee all quality control activities, including batch record review, product release, stability testing, and environmental monitoring.
• Manage quality investigations, deviations, out-of-specification (OOS) results, and corrective and preventive actions (CAPA) to ensure timely and effective resolution.
• Serve as the primary liaison with the Pharmacy, Medicines and Poisons Board (PMPB) of Malawi and other regulatory bodies during inspections and audits.
• Review and approve quality-related documents, including standard operating procedures (SOPs), specifications, validation protocols, and change controls.
• Conduct internal audits and supplier audits to ensure compliance with GMP and other relevant quality standards.
• Monitor quality metrics and trends, preparing regular reports for site management and global quality leadership.
• Ensure proper qualification and validation of equipment, processes, and systems used in pharmaceutical manufacturing.
• Promote a culture of quality and continuous improvement throughout the manufacturing facility.

Required Skills

• In-depth knowledge of WHO Good Manufacturing Practices (GMP), Malawian pharmaceutical regulations, and international quality standards.
• Strong leadership and team management abilities, with experience building and developing high-performing teams.
• Excellent analytical, problem-solving, and decision-making skills, with a keen attention to detail.
• Proven experience in managing regulatory inspections and quality audits from health authorities.
• Effective communication and interpersonal skills, with the ability to collaborate across departments and influence stakeholders.
• Proficiency in quality management software and Microsoft Office applications.
• Ability to work under pressure, manage multiple priorities, and meet strict deadlines.
• Strong ethical standards and a commitment to integrity and compliance.

Education

A Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biochemistry, or a related scientific field is required. A Master’s degree in Quality Assurance, Regulatory Affairs, or Pharmaceutical Sciences is highly preferred. Professional certifications such as Certified Quality Auditor (CQA) or Certified Quality Manager (CQM) are significant advantages. Continuous education in the latest regulatory guidelines and quality management trends is expected.

Experience

Minimum of 8 years of progressive experience in pharmaceutical quality assurance, with at least 3 years in a managerial or supervisory role within a GMP-regulated environment. Demonstrated experience in managing a full QMS, handling regulatory inspections, and leading quality investigations is essential. Experience in sterile product manufacturing or biologics is an advantage. A proven track record of implementing quality improvements and ensuring compliance in a manufacturing setting is required.

Benefits

• Competitive salary package with performance-based bonuses.
• Comprehensive health, dental, and vision insurance for employee and dependents.
• Retirement savings plan with company matching contributions.
• Generous paid time off, including annual leave, sick leave, and public holidays.
• Professional development opportunities and support for further education.
• Relocation assistance for candidates moving to Ntchisi.
• Employee assistance program and wellness initiatives.
• Life insurance and disability coverage.

Training

• Extensive onboarding program covering Novartis global quality systems and standards.
• Regular training on updated GMP guidelines, regulatory requirements, and quality management tools.
• Leadership and management development programs.
• Opportunities for international training and knowledge exchange within the Novartis network.
• Technical training on specific manufacturing processes and quality control techniques.

Working Environment

The Pharmaceutical Quality Assurance Manager will work in a modern, well-equipped pharmaceutical manufacturing facility in Ntchisi. The role involves a combination of office work and time on the manufacturing floor. The environment is dynamic and fast-paced, requiring close collaboration with production, engineering, supply chain, and regulatory affairs teams. Safety and quality are paramount, and all employees are expected to adhere to strict GMP and safety protocols. Novartis promotes a collaborative, inclusive, and innovative work culture where employees are encouraged to contribute ideas and drive improvements.

Application Process

Interested and qualified candidates are invited to submit their updated CV and a cover letter detailing their suitability for the role through the Novartis careers portal. The recruitment process will include an initial screening, technical assessments, and interviews with the hiring manager and senior quality leadership. Only shortlisted candidates will be contacted. Novartis is committed to a transparent and fair hiring process. For more information on this Job Vacancy in Malawi and other Employment in Malawi opportunities, you can also visit https://www.zambiajobssearch.com/.

Equal Opportunity Statement

Novartis is an equal opportunity employer committed to building an inclusive and diverse workforce. We value diversity and do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. All employment decisions are based on qualifications, merit, and business need. We are proud to be an employer of choice in Malawi, offering Hiring in Malawi that fosters professional growth and contributes to the nation’s healthcare sector.