About the Role
Our client, a globally recognized pharmaceutical organization, is seeking a highly motivated and detail-oriented Remote Pharmaceutical Quality Assurance Manager. This position is entirely remote, offering the flexibility to work from anywhere within South Africa. The successful candidate will be responsible for overseeing and implementing robust quality assurance systems and processes to ensure compliance with regulatory standards and company policies. You will play a critical role in maintaining the integrity and safety of our pharmaceutical products throughout their lifecycle. This role requires a proactive approach to quality management, a deep understanding of GMP, and the ability to drive continuous improvement initiatives. As a remote leader, you will leverage technology and strong communication skills to effectively manage a geographically dispersed team and collaborate with various departments. This is an excellent opportunity to make a significant impact on product quality and patient safety from a convenient remote setting.
Key Responsibilities
- Develop, implement, and maintain comprehensive Quality Management Systems (QMS) in compliance with regulatory requirements (e.g., GMP, ICH guidelines).
- Conduct internal audits and assessments to identify areas of non-compliance and implement corrective and preventive actions (CAPAs).
- Review and approve critical quality documents, including batch records, SOPs, validation protocols, and change controls.
- Manage external audits by regulatory agencies and customers, ensuring successful outcomes.
- Oversee product quality reviews and trend analysis to identify potential quality issues.
- Lead and mentor the Quality Assurance team, fostering a culture of quality excellence.
- Collaborate with Manufacturing, R&D, and other departments to resolve quality-related issues.
- Stay updated on evolving regulatory landscapes and industry best practices in pharmaceutical quality assurance.
- Manage vendor qualification and monitor supplier quality performance.
- Drive continuous improvement initiatives within the QA function.
Requirements
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field. A Master's degree is preferred.
- Minimum of 8 years of experience in pharmaceutical Quality Assurance, with at least 3 years in a management or supervisory role.
- Extensive knowledge of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other relevant regulatory guidelines.
- Proven experience in developing and managing QMS, conducting audits, and handling CAPAs.
- Excellent understanding of pharmaceutical manufacturing processes and quality control.
- Strong leadership, communication, and interpersonal skills, with the ability to manage remote teams effectively.
- Proficiency in using quality management software and electronic document management systems.
- Ability to analyze complex data, identify trends, and make sound quality-related decisions.
- Exceptional organizational and time management skills.
- Must be eligible to work remotely from Pietermaritzburg, KwaZulu-Natal or other locations within South Africa.
Benefits
- Our client offers a competitive salary and a comprehensive remote benefits package, including private health insurance, a retirement fund contribution, performance incentives, and generous paid time off.
- Professional development opportunities, including specialized training and conference attendance, are actively supported.
- This remote position allows for exceptional work-life balance and the opportunity to contribute to a globally impactful organization from the comfort of your home office.
- You will be empowered to drive quality initiatives and foster a strong quality culture across the company, regardless of physical location.