Mawethu Mema
Senior QA And QMS Professional
Cape Town
Summary
Experienced Quality Assurance and Systems Leader with 10+ years in GMP and ISO-regulated pharmaceutical and biotech environments. Expert in implementing, maintaining, and optimizing Quality Management Systems (QMS) across GxP domains. Proven track record in complaint management, deviations, CAPAs, PQRs, product release, regulatory inspections, training, GDP compliance, and supplier management. Strong cross-functional leadership, problem-solving, and digital systems expertise.
Overview
9
9
years of professional experience
8059
8059
years of post-secondary education
6
6
Certifications
1
1
Language
Work History
Executive Director: Pharmaceutical Services
PharmAlign Solutions
03.2025 - Current
- Managed a diverse team of professionals, fostering a collaborative work environment for increased productivity.
- Developed and implemented organizational strategies to achieve set goals and objectives and secured long-term success.
- Worked closely with organizational leadership and board of directors to guide operational strategy.
- Developed strategic partnerships with key stakeholders to expand the organization''s reach and influence.
- Leading consulting engagements in QMS implementation, SAHPRA, PIC, S, WHO regulatory compliance, and GMP inspection readiness.
- Responsible for developing full-scale Quality Management Systems, including Site Master Files (SMF), Validation Master Plans (VMP), SOPs, Contamination Control Strategies (CCS), and training frameworks.
- Overseeing supplier qualification, client liaison, and end-to-end project delivery for pharmaceutical and biotech clients.
- Managing business operations, company finances, strategic planning, and personnel.
- Strategic lead on cross-functional projects covering QC readiness, audit readiness, licensing submissions, risk assessments, and continuous improvement systems.
Quality Systems and Training Lead
Biovac
09.2022 - 02.2025
- Led the Quality Assurance Systems and Training team to ensure seamless operations, regulatory compliance, and alignment with GMP standards.
- Oversaw the development and optimization of quality systems, including Deviations, CAPAs, Change Controls, and Quality Risk Management, driving compliance and continuous improvement.
- Designed and delivered effective GMP training programs to enhance personnel proficiency and regulatory compliance.
- Managed cross-functional teams, fostering a high-performance culture through training, mentorship, and professional development initiatives.
- Spearheaded strategic planning and resource management to align departmental objectives with organizational goals, ensuring efficiency and cost-effectiveness.
- Provided expert guidance during internal and external audits, maintaining high compliance standards and operational excellence.
- Collaborated on digital system implementation and process optimization, ensuring alignment with global best practices and regulatory expectations.
- Monitored performance metrics using advanced data analysis, identifying improvement opportunities to inform strategic decision-making.
- Partnered with senior leadership, delivering insights and recommendations to drive organizational success.
- Collaborate with team members to define and address business requirements while providing support throughout the project lifecycle.
- Assisted in the maintenance of the Site Master File and contributed to local quality manuals.
Quality Systems Specialist
Biovac
11.2021 - 08.2022
- Managed CAPAs, Change Controls, and root cause analyses, improving QA workflows through the TrackWise Digital system.
- Supported QA initiatives in audits and non-conformance investigations, ensuring effective and timely resolutions.
- Coordinated Quality Management Reviews to enhance quality performance and drive improvements in QA processes.
- Implemented risk-based thinking strategies for proactive identification and mitigation of potential issues.
- Maintained an up-to-date knowledge base on industry advancements, incorporating new tools and techniques into the company''s practice.
- Streamlined quality systems documentation for increased efficiency and ease of access.
- Collaborated with cross-functional teams to develop robust processes, ensuring compliance with industry standards.
- Conducted regular audits to maintain adherence to established quality management system requirements.
- Mentored junior team members on best practices in quality systems management, contributing to their professional growth.
Quality Assurance Officer
Biovac
09.2017 - 10.2021
- Managed CAPAs, Change Controls, and root cause analyses, improving QA workflows through the TrackWise Digital system.
- Supported QA initiatives in audits and non-conformance investigations, ensuring effective and timely resolutions.
- Coordinated Quality Management Reviews to enhance quality performance and drive improvements in QA processes.
- Facilitated effective communication between departments regarding quality matters, fostering a collaborative working environment.
- Conducted evaluations to identify weak areas and identify problematic issues while promoting corrective methods.
- Collaborated with cross-functional teams for timely resolution of quality issues and concerns.
- Improved manufacturing processes by identifying areas of inefficiency and recommending corrective actions.
- Developed training programs for employees to enhance their understanding of quality assurance principles and practices.
Compliance Officer
Aspen Pharmacare
06.2016 - 08.2017
- Led GMP audits, managed CAPA, and ensured product quality during manufacturing and packaging.
- Managed deviations and corrective actions to uphold regulatory standards.
- Assisted with internal and external audits to confirm compliance with applicable laws and regulations.
- Developed comprehensive training programs to increase employee awareness of compliance requirements and expectations.
Education
Strategic Leadership - Business Management
Gordons Institute of Business Science
Pretoria, GP11-2023
New Management Program - Business Management
Wits Business School
Johannesburg, GP10-2022
National Diploma - Industrial Engineering
Cape Peninsula University of Technology
Cape Town, WPSenior Certificate - Matric
David Mama Comprehensive High School
East London, ECSkills
Quality Management Systems (QMS)
QMS Implementation and Oversight
Corrective and Preventive Actions (CAPA)
GxP Compliance (GDP, GMP, ISO 9001, ISO 13485, PIC/S)
Change Control, CAPA, Deviations, Complaint Handling
Process Optimization & Continuous Improvement (CI)
Document Control QRM PQR Regulatory Inspections
Self-Inspections Risk Management Authority Engagement
Supplier Qualification & Audit Planning
Capacity Planning and Performance Optimization
Quality Standards and Business Systems
Team Leadership Training & Development Strategic QA Planning
Industry Standards and Regulatory Requirements
Digital QMS & LMS Tools (TrackWise Digital, DMS, BI tools)
Data Analysis Process Optimization Performance Metrics
GDP Oversight: Warehousing, Distribution & Returns
Digital Transformation
Health, Safety, and Environmental (HSE) Compliance
Strong Analytical and Organizational Skills
Commercial Awareness and Task Management
Self-Management and Proactive Leadership
Inspection & Regulatory Readiness
Business Management and Quality Improvement Projects
Staff management
Budgeting and financial management
Project management
Strategic planning
Business development
Certification
Six Sigma DMAIC, Black Belt: 2KO Africa/Six Sigma South Africa, Cape Town, WC 2023 – In-progress
Accomplishments
- Designed and launched a comprehensive training program in 2024, boosting compliance and operational capability across the organization.
- Presented at the Honeywell Software Symposium (2023) in Dallas, Texas, sharing insights on optimizing Quality Management Reviews in vaccine manufacturing.
- Successfully implemented TrackWise Digital EQMS, streamlining quality systems and ensuring alignment with global standards.
Cover Letter
- Mawethu Mema
- Senior Quality Assurance Professional
- Cell: +27 83 474 9132
- Email: memamawethu@gmail.com
- Location: Cape Town, South Africa
- LinkedIn: www.linkedin.com/in/mawethu-mema
- Date: 2025-07-16
- To: Hiring Manager
- DI Regulatory Consultants
- Cape Town
- Re: Application for the Position of Quality Assurance Officer
- Dear Hiring Manager
- I am writing to express my keen interest in the advertised position of Quality Assurance Officer at DI Regulatory Consultants. With over a decade of experience in GMP-regulated environments, and a proven track record of implementing and maintaining robust Pharmaceutical Quality Management Systems, I am confident in my ability to make a meaningful contribution to your team.
- In my previous role as Quality Systems and Training Lead at Biovac, I led quality systems governance, document control, and regulatory compliance initiatives. My responsibilities included oversight of CAPAs, change controls, deviations, Quality Risk Management, and regulatory inspections. I have authored and maintained critical GMP documentation, and I successfully implemented TrackWise Digital for enhanced QMS performance.
- My experience also extends to managing product complaints, recalls, and customer feedback, leading technical agreements, and conducting third-party and self-inspections. I've consistently ensured readiness for SAHPRA inspections and have played a key role in aligning internal practices with global quality standards and PIC/S guidelines.
- In addition to my technical expertise, I bring strong interpersonal skills, analytical thinking, and a commitment to continuous improvement.
- I am enthusiastic about the opportunity to join DI Regulatory Consultants, a company known for its commitment to regulatory excellence. I am confident that my background in QMS implementation, audit readiness, and quality oversight aligns seamlessly with your expectations for this role.
- Thank you for considering my application. I would welcome the opportunity to further discuss how I can support your quality objectives. I am available for an interview at your convenience.
- Warm regards
Timeline
Executive Director: Pharmaceutical Services
PharmAlign Solutions
03.2025 - Current
Quality Systems and Training Lead
Biovac
09.2022 - 02.2025
Quality Systems Specialist
Biovac
11.2021 - 08.2022
Quality Assurance Officer
Biovac
09.2017 - 10.2021
Compliance Officer
Aspen Pharmacare
06.2016 - 08.2017
Strategic Leadership - Business Management
Gordons Institute of Business Science
New Management Program - Business Management
Wits Business School
National Diploma - Industrial Engineering
Cape Peninsula University of Technology
Senior Certificate - Matric
David Mama Comprehensive High School