Senior Pharmaceutical Quality Assurance Specialist (Remote)

Placements24; Queenstown; Remote; NZD 110,000 - 160,000; Full time

Benefits offered by this job

Competitive salary

Health, dental, and vision insurance

Retirement savings plan

Generous paid time off

Job summary

Placements24 is recruiting on behalf of a leading pharmaceutical organization for a Senior Pharmaceutical Quality Assurance Specialist to join a remote-first team. You will ensure products and processes meet cGMP, ICH, and FDA/EMA standards, and lead QA activities across the product lifecycle.

The role requires seven+ years in QA/QC, a life sciences degree, strong auditing, CAPA, and change-control experience, with the ability to collaborate with global teams via digital platforms.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Microbiology or related life science.
• 7+ years of experience in pharmaceutical QA or QC.
• Strong knowledge of cGMP, ICH guidelines and regulatory standards (FDA/EMA).
• Auditing, deviation management, CAPA and change control experience.
• Remote collaboration and excellent documentation skills.

Responsibilities

• Develop, maintain, and improve the QMS in line with cGMP and regulations.
• Conduct internal and external audits of suppliers, CMO, and processes.
• Manage deviations, OOS, CAPA, and change control workflows.
• Review batch records, validation docs, and quality records.
• Support regulatory inspections and respond to agency queries.
• Provide training on QA principles and GMP compliance.
• Monitor quality metrics and report trends for improvement.
• Collaborate with R&D, Manufacturing, QC to integrate quality across the lifecycle.
• Stay updated with evolving regulatory requirements and best practices.

Skills

GMP knowledge

Auditing

CAPA

Change control

Quality metrics

Remote collaboration

Education

Bachelor's degree in Pharmacy, Chemistry, Microbiology or related life science

Tools

Quality management software

Document control systems

Job description

About the Role

Our client, a leading pharmaceutical organization renowned for its commitment to excellence, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Specialist to join their fully remote team. This critical position will ensure that all pharmaceutical products and processes comply with stringent quality standards and regulatory requirements. You will be instrumental in developing, implementing, and maintaining robust quality management systems, conducting audits, and driving continuous improvement initiatives. This is a remote-first role that demands a proactive approach, exceptional attention to detail, and the ability to collaborate effectively with global teams through digital platforms. We are looking for a self-motivated professional with a deep understanding of GMP and a proven ability to uphold the highest standards of pharmaceutical quality from anywhere. Your contributions will be vital in safeguarding product integrity and patient safety.

Key Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS) in accordance with cGMP and other relevant regulations.
• Conduct internal and external audits of suppliers, contract manufacturers, and internal processes.
• Manage deviations, out-of-specification (OOS) results, and CAPA processes.
• Review and approve batch records, validation protocols, and other quality-related documentation.
• Participate in regulatory inspections and respond to regulatory agency queries.
• Provide training to personnel on quality assurance principles and GMP compliance.
• Monitor key quality metrics and performance indicators, reporting on trends and areas for improvement.
• Collaborate with various departments (e.g., R&D, Manufacturing, Quality Control) to ensure quality is integrated throughout the product lifecycle.
• Stay current with evolving regulatory requirements and industry best practices.
• Support the qualification and validation of equipment and processes.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, or a related life science discipline.
• Minimum of 7 years of experience in pharmaceutical Quality Assurance or Quality Control.
• Comprehensive knowledge of cGMP, ICH guidelines, and other relevant regulatory standards (e.g., FDA, EMA, SAHPRA).
• Proven experience in auditing, deviation management, CAPA, and change control processes.
• Strong understanding of pharmaceutical manufacturing operations and product lifecycle.
• Excellent analytical, problem-solving, and decision-making skills.
• Exceptional written and verbal communication skills, essential for remote collaboration and documentation.
• Demonstrated ability to work independently, manage multiple tasks, and meet deadlines in a remote environment.
• Proficiency in quality management software and tools.

Benefits

• competitive salary
• comprehensive health, dental, and vision insurance
• a robust retirement savings plan
• generous paid time off