Senior Pharmaceutical Quality Assurance Manager

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

Benefits offered by this job

Executive pay & bonus

Health benefits

Retirement plan

Wellness program

Hybrid work model

Job summary

Placements24 in Randburg, South Africa, seeks a Senior Pharmaceutical Quality Assurance Manager to lead the QA team and drive a robust QMS ensuring GMP compliance and product quality. You will oversee audits, document reviews, and strategic quality initiatives on-site with remote support for documentation.

The role blends on-site leadership with remote management of documentation and planning, offering a hybrid work model and a pathway to shape the company’s regulatory readiness and quality

Qualifications

• Master’s degree or PhD in Pharmaceutical Sciences, Chemistry, or related field.
• Minimum 8 years of progressive QA experience in pharma.
• Proven leadership of QA teams and Regulatory inspections.

Responsibilities

• Develop and maintain the QMS in line with GMP and regulatory requirements.
• Lead and mentor the QA team to sustain high performance.
• Oversee internal and external audits and close findings promptly.
• Review batch records, validation protocols, and SOPs for approval.
• Coordinate deviation investigations, change control, and CAPA.
• Serve as liaison with regulatory authorities during inspections.

Skills

QA Leadership

Regulatory Knowledge

Audits & Compliance

Communication

Education

MS/PhD in Pharma

Job description

About the Role

Our client is seeking a highly experienced Senior Pharmaceutical Quality Assurance Manager to lead their QA team in Randburg. This leadership role is responsible for establishing, maintaining, and continuously improving the company's Quality Management System (QMS) to ensure compliance with all relevant regulatory standards. You will oversee quality operations, conduct audits, and drive a culture of quality throughout the organization. This hybrid role requires a strong presence on-site for team leadership and critical operations, with flexibility for remote management of documentation and strategic planning.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with GMP and other regulatory requirements.
• Lead and mentor the Quality Assurance team, fostering a high-performance culture.
• Oversee internal and external audits, manage audit responses, and ensure timely closure of findings.
• Review and approve critical quality documents, including batch records, validation protocols, and SOPs.
• Manage deviation investigations, change control processes, and CAPA implementation.
• Act as a key liaison with regulatory authorities during inspections and audits.

Requirements

• Master's degree or PhD in Pharmaceutical Sciences, Chemistry, or a related field.
• Minimum of 8 years of progressive experience in pharmaceutical Quality Assurance.
• Demonstrated experience in leading and managing QA teams.
• In-depth knowledge of global GMP regulations (e.g., FDA, EMA) and quality systems.
• Exceptional leadership, communication, and problem-solving skills.

Benefits

• Executive-level salary and bonus structure.
• Comprehensive health, retirement, and wellness benefits.
• Hybrid work model offering a balance between on-site leadership and remote flexibility.
• Opportunities for strategic impact and career advancement.
• A crucial role in ensuring the quality and safety of pharmaceutical products.