Quality Assurance Director

Placements24; Gqeberha; Hybrid; ZAR 1,200,000 - 2,500,000; Full time

Benefits offered by this job

Performance bonus

Health benefits

Annual leave

Remote work tools

Professional development

Retirement matching

Job summary

Placements24 seeks a seasoned Quality Assurance Director to lead QA operations for a pharmaceutical manufacturer in a fully remote role. You will drive the QMS, ensure GMP/ICH compliance, and oversee audits across the product lifecycle.

You will mentor a remote QA team, manage risk, and collaborate with R&D, manufacturing, and regulatory affairs to safeguard product quality and regulatory readiness. This is a strategic leadership position with a focus on continuous improvement.

Qualifications

• 10+ years in Quality Assurance within pharma/biotech.
• 5+ years in leadership with QA team management.
• Extensive GMP, ICH, and regulatory submission knowledge.
• Proven experience developing and implementing QMS.
• Excellent communication and remote cross-functional influence.
• Ability to support regulatory inspections and audits.

Responsibilities

• Develop, implement, and maintain a robust QMS across the organization.
• Oversee QA activities including batch record review, deviations, CAPA, change control, audits.
• Ensure GMP compliance and other quality guidelines.
• Lead and mentor the QA team remotely.
• Conduct risk assessments and mitigation strategies.
• Collaborate with R&D, manufacturing, and regulatory to ensure quality throughout development through post-market.
• Prepare for regulatory inspections and customer audits.
• Stay updated on regulatory requirements and best practices.
• Drive continuous improvement in QA.

Skills

QA leadership

GMP knowledge

Regulatory affairs

Risk management

Quality systems

Communication

Education

Bachelor's degree in Pharmacy/Chemistry/Biology

Advanced degree preferred

Job description

About the Role

Our client, a reputable pharmaceutical manufacturer, is seeking a highly skilled and experienced Quality Assurance Director to lead their QA operations. This fully remote role is crucial for maintaining the highest standards of product quality and regulatory compliance throughout the manufacturing lifecycle. You will be responsible for developing, implementing, and overseeing the company's Quality Management System (QMS), ensuring adherence to all relevant Good Manufacturing Practices (GMP) and international regulatory standards. The ideal candidate is a detail-oriented leader with extensive knowledge of pharmaceutical quality control, risk management, and regulatory affairs. This position offers the chance to make a significant impact on product safety and efficacy from a remote location, working closely with manufacturing, R&D, and regulatory teams. We are looking for a proactive individual who can champion a culture of quality excellence across the organization, driving continuous improvement in all quality-related processes.

Key Responsibilities

• Develop, implement, and maintain a robust Quality Management System (QMS) in compliance with global regulatory standards (e.g., FDA, EMA, SAHPRA).
• Oversee all QA activities, including batch record review, deviation management, CAPA implementation, change control, and internal/external audits.
• Ensure adherence to Good Manufacturing Practices (GMP) and other relevant quality guidelines.
• Lead and mentor the QA team, providing guidance and fostering a culture of quality and compliance.
• Conduct risk assessments and implement mitigation strategies for quality-related issues.
• Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure product quality and compliance from development through post-market.
• Prepare for and manage regulatory inspections and customer audits.
• Stay abreast of evolving regulatory requirements and industry best practices.
• Drive continuous improvement initiatives within the quality assurance function.

Requirements

• Minimum of 10 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry.
• At least 5 years in a leadership role with direct management responsibility for QA teams.
• Extensive knowledge of GMP, ICH guidelines, and regulatory submission requirements.
• Proven experience in developing and implementing effective QMS.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent communication, interpersonal, and leadership skills, with the ability to influence cross-functional teams remotely.
• Experience with regulatory inspections and audit management.
• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field; advanced degree preferred.
• Must have reliable internet access and a suitable home office setup for a fully remote role.

Benefits

• Competitive annual salary and performance bonus.
• Comprehensive health and wellness benefits package.
• Generous annual leave and sick leave policy.
• Company-provided laptop and remote work tools.
• Professional development opportunities, including external training and conference attendance.
• Retirement savings plan with company matching.
• Opportunity to lead quality initiatives in a critical industry.