Senior Pharmaceutical Quality Assurance Manager

Placements24; Cape Town; In loco; ZAR 900.000 - 1.800.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive remuneration

Health & wellness benefits

Training & conferences

Career development

Descrizione del lavoro

Placements24 seeks a Senior Pharmaceutical Quality Assurance Manager to oversee QA at a Cape Town facility. You will lead the QA team, ensure GMP/GDP compliance, and drive audits, CAPAs, and continuous quality improvements across manufacturing and distribution.

Ideal candidate brings 7+ years in QA/QC with managerial experience, strong regulatory knowledge, and excellent leadership and communication skills to uphold product safety and efficacy.

Competenze

• Master's or Bachelor's degree in Pharmacy, Chemistry, Biology, or related.
• 7+ years in pharmaceutical QA/QC, with ≥3 years in management.
• GMP, GDP and international regulatory guidelines knowledge.
• Experience managing quality systems, audits, and inspections.
• Understanding of manufacturing processes and lifecycle management.
• Strong analytical and decision-making skills.
• Proven leadership and people-management ability.
• Excellent communication and collaboration skills.
• Familiar with quality management software/tools.
• Experience in Western Cape pharma sector advantageous.

Mansioni

• Develop and maintain QA programs compliant with GMP/GDP.
• Lead QA team with mentorship and performance reviews.
• Conduct internal audits and inspections for compliance.
• Manage external audits by regulators and partners.
• Review SOPs, batch records, and validation protocols.
• Investigate deviations and CAPAs.
• Ensure manufacturing processes meet quality standards.
• Collaborate with Production, R&D to resolve issues.
• Stay updated on regulatory changes and best practices.
• Lead continuous improvement projects for quality and efficiency.

Conoscenze

QA leadership

GMP/GDP knowledge

Audits & inspections

Regulatory compliance

Quality systems management

CAPA & problem solving

Cross-functional collaboration

Quality documentation

Formazione

Pharmacy degree

Science background

Strumenti

Quality management software

Descrizione del lavoro

About the Role

Our client, a distinguished name in the pharmaceutical industry, is actively seeking a seasoned Senior Pharmaceutical Quality Assurance Manager to oversee and enhance quality systems at their state-of-the-art facility in Cape Town, Western Cape. This critical role involves ensuring that all pharmaceutical products manufactured and distributed meet the highest standards of quality, safety, and efficacy. You will lead a dedicated QA team, implement robust quality control measures, and drive continuous improvement initiatives across all operational areas. The successful candidate will play a vital role in maintaining regulatory compliance and fostering a culture of quality excellence within the organization. This position is essential for upholding our client's reputation for producing high-quality pharmaceuticals. You will be instrumental in developing and executing strategies that align with global regulatory standards and internal company policies, ensuring product integrity from development through to market release. This is a challenging yet rewarding opportunity to contribute significantly to public health by ensuring the safety and effectiveness of pharmaceutical products.

Key Responsibilities

• Develop, implement, and maintain comprehensive Quality Assurance (QA) programs and systems in compliance with regulatory requirements (e.g., GMP, GDP).
• Oversee the QA team, providing leadership, mentorship, and performance management.
• Conduct internal audits and inspections to ensure compliance and identify areas for improvement.
• Manage external audits from regulatory authorities and partners, ensuring successful outcomes.
• Review and approve critical quality documents, including SOPs, batch records, and validation protocols.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).
• Ensure that all pharmaceutical manufacturing processes and facilities meet stringent quality standards.
• Collaborate with Production, R&D, and other departments to resolve quality issues and drive process improvements.
• Stay updated on evolving regulatory landscapes and industry best practices in pharmaceutical quality management.
• Lead and participate in continuous improvement projects aimed at enhancing product quality and operational efficiency.

Requirements

• Master's or Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 7 years of experience in pharmaceutical Quality Assurance or Quality Control, with at least 3 years in a managerial role.
• In-depth knowledge of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and relevant international regulatory guidelines.
• Proven experience in managing quality systems, audits (internal and external), and regulatory inspections.
• Strong understanding of pharmaceutical manufacturing processes, product development, and lifecycle management.
• Excellent analytical, problem-solving, and decision-making skills.
• Demonstrated leadership and team management capabilities.
• Exceptional communication, interpersonal, and influencing skills.
• Proficiency in quality management software and tools.
• Experience working in the Western Cape pharmaceutical sector is advantageous.

Benefits

• Our client offers a competitive remuneration package, including an attractive salary and performance-based incentives. Comprehensive health and wellness benefits are provided, along with opportunities for professional growth through training programs, conferences, and career development initiatives. This role presents a significant opportunity to lead quality initiatives at a leading pharmaceutical company in Cape Town and to make a lasting impact on patient safety. Employees are part of a supportive and collaborative work environment that values expertise and dedication. We are committed to fostering a culture of continuous improvement and ensuring our employees have the resources and support needed to excel in their roles. The location in Cape Town offers a desirable lifestyle with excellent amenities and a vibrant cultural scene.