Senior Pharmaceutical Quality Assurance Manager

Placements24; Mossel Bay; Hybrid; ZAR 1,000,000 - 1,600,000; Full time

Benefits offered by this job

Bonus opportunities

Health insurance

Retirement plan

Relocation assistance

Job summary

Placements24 is seeking a Senior Pharmaceutical Quality Assurance Manager based in Mossel Bay, Western Cape, with hybrid work options. The role oversees QMS, audits, and regulatory inspections to ensure cGMP compliance and product quality across operations.

The ideal candidate has 7+ years in QA/QC with 3+ in leadership, strong regulatory exposure, and excellent leadership and communication skills. Relocation support may be available, with a competitive package and benefits.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology or related science field is required.
• Experience in managing QA/QC teams and quality systems is essential.
• Strong knowledge of cGMP regulations and regulatory inspections is essential.

Responsibilities

• Develop, implement, and maintain the QMS compliant with cGMP and ICH.
• Oversee QA activities including batch review, deviations, CAPA, change control, supplier quality.
• Lead internal audits and support regulatory inspections by authorities and customers.
• Investigate quality incidents, identify root causes, implement CAPA.
• Review and approve validation protocols and reports for processes and equipment.
• Monitor supplier qualification and performance; mentor QA staff.
• Drive continuous improvement of QA systems and KPIs; report trends to management.

Skills

Quality Assurance

Regulatory knowledge

Audits

Leadership

Education

Bachelor’s degree in Pharmacy, Chemistry, Biology

Master’s degree preferred

Job description

About the Role

Our client, a highly respected pharmaceutical company renowned for its commitment to quality and innovation, is seeking an experienced Senior Pharmaceutical Quality Assurance Manager. This role is crucial in upholding the stringent quality standards that define our products and operations. Based in the picturesque region of Mossel Bay, Western Cape , this position offers a hybrid work arrangement, allowing for a blend of on-site collaboration and remote flexibility. The Senior QA Manager will be responsible for overseeing and implementing comprehensive quality management systems, ensuring compliance with all relevant regulatory requirements, and driving continuous improvement initiatives across the organization. This is an excellent opportunity to lead and shape the quality landscape within a reputable pharmaceutical firm.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with cGMP, ICH, and other relevant international regulations.
• Oversee and manage all aspects of quality assurance, including batch record review, deviation management, CAPA implementation, change control, and supplier quality management.
• Conduct internal audits and support external audits by regulatory agencies and customers.
• Lead investigations into quality incidents, identify root causes, and implement effective corrective and preventive actions.
• Review and approve validation protocols and reports for manufacturing processes, equipment, and analytical methods.
• Ensure the qualification and ongoing monitoring of raw material and component suppliers.
• Train and mentor QA staff and personnel across different departments on quality procedures and cGMP principles.
• Act as a key point of contact for regulatory inspections and inquiries.
• Monitor quality metrics and key performance indicators (KPIs), reporting on trends and areas for improvement to senior management.
• Contribute to the continuous improvement of quality systems and processes to enhance efficiency and compliance.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field. A Master's degree is preferred.
• A minimum of 7 years of experience in Pharmaceutical Quality Assurance or Quality Control, with at least 3 years in a management or supervisory role.
• Extensive knowledge of cGMP regulations (e.g., FDA 21 CFR Parts 210/211, EU GMP) and quality management systems.
• Proven experience in conducting internal and external audits, and managing regulatory inspections.
• Strong understanding of pharmaceutical manufacturing processes, analytical testing, and validation principles.
• Excellent leadership, communication, and interpersonal skills.
• Demonstrated ability to manage complex projects and drive change initiatives.
• Proficiency in quality management software and tools.
• Strong analytical and problem-solving skills with meticulous attention to detail.
• Ability to work effectively in a hybrid environment, balancing on-site and remote responsibilities.

Benefits

• Competitive salary and performance-based bonus opportunities.
• Comprehensive health, dental, and vision insurance.
• Retirement fund and pension plan.
• Generous paid annual leave.
• Opportunities for professional development, including external training and conferences.
• Relocation assistance may be available.
• A stable and reputable work environment with a focus on employee well-being.