Senior Pharmaceutical Quality Assurance Manager

Placements24; Soweto; On-site; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Annual bonus

Medical aid

Life insurance

Provident fund

Generous leave entitlements

Job summary

Placements24 seeks a Senior Pharmaceutical QA Manager in Soweto, Gauteng to lead QA operations and maintain cGMP compliance. The role oversees audits, CAPA, change control, and regulatory liaison, ensuring product quality and safety.

The ideal candidate will have 7+ years in QA with 3+ years in management, strong leadership, and deep knowledge of regulatory standards in pharma manufacturing.

Qualifications

• Bachelor's degree in Pharmacy or Life Sciences; advanced degree preferred.
• 7+ years in Pharmaceutical QA with 3+ years in management.
• Deep knowledge of cGMP and quality systems.
• Experience with audits, investigations, CAPA and change control.
• Strong leadership and communication skills; attention to detail.

Responsibilities

• Lead QA department, develop staff, and manage performance.
• Develop, implement, and maintain the QMS.
• Ensure cGMP compliance and regulatory readiness.
• Oversee internal/vendor audits and inspections.
• Manage deviation investigations, CAPA, and changes.
• Review batch records and validation documents.
• Oversee QA training and compliance programs.
• Contribute to lifecycle management and risk assessments.
• Act as main liaison with regulatory authorities.
• Drive continuous QA improvements across manufacturing.

Skills

QA leadership

Quality audits

CAPA management

Change control

Regulatory liaison

Team development

cGMP knowledge

Analytical thinking

Education

B.Pharm / related field

Advanced degree preferred

Tools

Electronic QMS

Job description

About the Role

Our client, a prominent pharmaceutical company, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Manager to oversee quality systems and ensure compliance at their facility in Soweto, Gauteng . This critical leadership role involves managing the Quality Assurance team, implementing and maintaining robust QA processes, and ensuring adherence to cGMP and other relevant regulatory standards. The successful candidate will play a key role in upholding the company's commitment to product quality, safety, and regulatory compliance. We are looking for a seasoned QA professional with a strong understanding of pharmaceutical operations and a proven ability to lead and develop a team. This position offers a significant opportunity to impact quality operations in Soweto, Gauteng .

Key Responsibilities

• Lead and manage the Quality Assurance department, including staff development and performance management.
• Develop, implement, and maintain the company's Quality Management System (QMS).
• Ensure compliance with cGMP regulations, ICH guidelines, and other relevant regulatory requirements.
• Oversee and conduct internal audits, vendor audits, and support regulatory inspections.
• Manage deviation investigations, CAPA implementation, and change control processes.
• Review and approve batch records, validation documents, and other critical quality documents.
• Oversee the training program for QA and relevant personnel on quality systems and compliance.
• Contribute to product lifecycle management and risk assessment activities.
• Act as a key point of contact for regulatory authorities regarding quality matters.
• Drive continuous improvement initiatives within the QA department and across manufacturing operations.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field; advanced degree preferred.
• Minimum of 7 years of experience in Pharmaceutical Quality Assurance, with at least 3 years in a management or supervisory role.
• In-depth knowledge of cGMP regulations and pharmaceutical quality systems.
• Proven experience in managing audits, investigations, CAPAs, and change control.
• Strong understanding of pharmaceutical manufacturing processes and product lifecycle.
• Excellent leadership, team management, and communication skills.
• Strong analytical and problem-solving abilities.
• Meticulous attention to detail and a commitment to quality excellence.
• Experience with electronic QMS is desirable.
• Ability to effectively interact with regulatory agencies.

Benefits

Our client offers a competitive salary package, including annual bonuses and performance incentives. Comprehensive medical aid, life insurance, and a provident fund are provided. Opportunities for professional growth and development, such as advanced training and certifications, are available. The work environment in Soweto, Gauteng , is committed to fostering a culture of quality and compliance. Generous annual leave and sick leave allowances are standard. This role offers significant potential for career advancement within a respected pharmaceutical organization.