Remote Pharmaceutical Quality Assurance Manager

Placements24

Pietermaritzburg

Hybrid

ZAR 900,000 - 1,500,000

Full time

4 days ago
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Benefits offered by this job

Private health insurance
Retirement fund contribution
Performance incentives
Generous paid time off
Professional development opportunities

Job summary

Placements24 is recruiting a Remote Pharmaceutical Quality Assurance Manager for a globally recognized organization. This fully remote role operates within South Africa, focusing on implementing robust QMS, GMP/GDP compliance, and CAPA processes to safeguard product quality and patient safety.

You will lead a dispersed QA team, conduct audits, review batch records and change controls, and collaborate with Manufacturing and R&D to resolve quality issues.

Qualifications

  • Bachelor’s degree in Pharmacy, Chemistry, Biology or related field (Master’s preferred).
  • 8+ years of pharmaceutical QA experience with leadership exposure.
  • Strong GMP/GDP knowledge and regulatory familiarity.
  • Experience in developing and managing QMS, audits, and CAPAs.

Responsibilities

  • Develop, implement, and maintain Quality Management Systems in line with GMP and regulatory standards.
  • Conduct internal audits and drive CAPA closure.
  • Review and approve batch records, SOPs, validation protocols, and change controls.
  • Manage external audits by regulators and customers.
  • Oversee product quality reviews and trend analyses.
  • Lead and mentor the QA team, fostering a quality-minded culture.
  • Collaborate with Manufacturing, R&D, and other departments to resolve QA issues.
  • Stay updated on evolving regulatory landscapes and best practices.
  • Oversee vendor qualification and monitor supplier kwaliteit.

Skills

Quality leadership
Regulatory knowledge
GMP expertise
CAPA management
Audit experience

Education

Bachelor's degree in Pharmacy/C Chemistry/ Biology
Master's degree preferred

Tools

QMS software
Electronic Document Management (EDMS)

Job description

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.
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