Pharmaceutical Quality Assurance Manager

Placements24; Queenstown; In loco; NZD 180.000 - 240.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive salary package

Comprehensive health insurance

Professional development and training

Leadership role in growing company

Relocation assistance may be provided

Retirement savings plan

Supportive QA team environment

Descrizione del lavoro

Placements24 is seeking an experienced Pharmaceutical Quality Assurance Manager to lead QA operations for a rapidly expanding pharmaceutical company. The role oversees the QMS, audits, regulatory compliance, and continuous improvement initiatives to ensure patient safety and high-quality products.

The ideal candidate has a strong GMP background, proven leadership, and the ability to guide cross-functional teams in manufacturing, R&D, and regulatory affairs.

Competenze

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or related field.
• Minimum of 7 years of progressive experience in Quality Assurance within the pharmaceutical industry.
• Proven experience in managing a QA department and leading audit processes.
• In-depth knowledge of GMP regulations (FDA, EMA) and quality management systems.
• Strong understanding of pharmaceutical manufacturing processes and quality control principles.
• Excellent leadership, communication, interpersonal, and problem-solving skills.
• Demonstrated ability to interpret and apply complex regulatory requirements.
• Experience with validation activities (process, equipment, cleaning).
• Proficiency in using quality management software and tools.
• Ability to work effectively under pressure and manage multiple priorities.

Mansioni

• Develop, implement, and maintain the Quality Management System (QMS) to ensure compliance with GMP and other regulations.
• Oversee QA activities, including batch record review and release, deviation management, CAPA implementation, change control, and complaint handling.
• Lead and participate in internal and external audits and ensure timely closure of audit findings.
• Manage and mentor the QA team, fostering a culture of quality and continuous improvement.
• Ensure manufacturing and testing processes adhere to procedures and regulatory requirements.
• Review and approve validation protocols and reports for processes, equipment, and analytical methods.
• Stay updated on current GMP regulations and industry best practices.
• Collaborate with R&D, manufacturing, and other departments to resolve quality issues.
• Monitor key quality metrics and provide regular reports to senior management.
• Champion quality initiatives across the organization.

Conoscenze

Leadership

GMP knowledge

Quality mindset

Problem solving

Formazione

Bachelors in Pharmacy/Chemistry/Life Sciences

Masters preferred

Strumenti

Quality management software

Descrizione del lavoro

About the Role

Our client, a rapidly expanding pharmaceutical company committed to delivering high-quality healthcare solutions, is seeking an experienced Pharmaceutical Quality Assurance Manager to lead their QA operations in Queenstown, Eastern Cape. This role is critical for ensuring that all pharmaceutical manufacturing and development activities comply with stringent regulatory standards and internal quality policies. You will be responsible for overseeing the Quality Management System (QMS), managing audits, ensuring regulatory compliance, and driving continuous improvement initiatives. The ideal candidate possesses a deep understanding of GMP regulations, a strong leadership background, and exceptional problem-solving skills. This is an on-site position, requiring your full-time presence to effectively manage and guide the QA team and collaborate with other departments, including manufacturing, R&D, and regulatory affairs. Your leadership will be pivotal in maintaining the integrity and reliability of our client's pharmaceutical products, ensuring patient safety and market trust.

Key Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS) to ensure compliance with GMP and other relevant regulations.


• Oversee all QA activities, including batch record review and release, deviation management, CAPA implementation, change control, and complaint handling.


• Lead and participate in internal and external audits (regulatory inspections, customer audits) and ensure timely closure of audit findings.


• Manage and mentor the Quality Assurance team, fostering a culture of quality and continuous improvement.


• Ensure that all manufacturing and testing processes adhere to approved procedures and regulatory requirements.


• Review and approve validation protocols and reports for processes, equipment, and analytical methods.


• Stay updated on current GMP regulations and industry best practices, providing guidance to the organization.


• Collaborate with R&D, manufacturing, and other departments to resolve quality issues and implement effective solutions.


• Monitor key quality metrics and provide regular reports to senior management.


• Champion quality initiatives across the organization.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field. A Master's degree is preferred.


• Minimum of 7 years of progressive experience in Quality Assurance within the pharmaceutical industry.


• Proven experience in managing a QA department and leading audit processes.


• In-depth knowledge of GMP regulations (e.g., FDA, EMA) and quality management systems.


• Strong understanding of pharmaceutical manufacturing processes and quality control principles.


• Excellent leadership, communication, interpersonal, and problem-solving skills.


• Demonstrated ability to interpret and apply complex regulatory requirements.


• Experience with validation activities (process, equipment, cleaning).


• Proficiency in using quality management software and tools.


• Ability to work effectively under pressure and manage multiple priorities.

Benefits

• Competitive salary package commensurate with experience and leadership capabilities.


• Comprehensive health insurance, including medical and dental coverage.


• Opportunities for professional development and advanced training.


• Leadership role in a growing pharmaceutical company with significant impact.


• Contribution to ensuring the quality and safety of essential medicines.


• Retirement savings plan.


• Supportive work environment with a dedicated QA team.


• Relocation assistance may be considered for the right candidate.