Quality Assurance Auditor

The Senior Quality Assurance Auditor plays a critical role in ensuring quality and compliance with regulatory requirements. They conduct internal and external audits to guarantee adherence to local and international standards.

• Evaluate systems, processes, affiliates, vendors, business partners, and investigator sites for compliance with regulatory requirements.
• Schedule and conduct GVP/GCP audits according to the global audit plan, ensuring compliance with local and international guidelines and regulations.
• Prepare audit reports and manage follow-up activities with minimal guidance.
• Conduct meetings with senior management to discuss audit observations and responses.
• Support the implementation and maintenance of the GVP/GCP risk-based strategy, including development of the annual audit plan.
• Ensure audit tracking tools are up-to-date.
• Participate in regulatory inspections and external audits when required.
• Review and provide input into the quality sections of the Pharmacovigilance System Master File (PSMF).
• Maintain a high level of knowledge of global industry expectations and GVP/GCP regulations.
• Train and mentor junior team members.

• Bachelor's degree in a relevant field, such as pharmacy or life sciences.
• Fluency in written and spoken English; additional language skills are beneficial.
• Minimum five years of experience in the pharmaceutical industry.
• At least one year of experience in GVP/GCP auditing with EU/FDA/global regulatory requirements.
• Strong knowledge of EMA, FDA, and ICH guidelines.
• Attention to detail and ability to work independently.
• Collaboration and partnering: demonstrates ability to work effectively with others within the organization and external partners to achieve quality goals.
• Communication skills: strong verbal skills and effective writing abilities.
• Project management: demonstrates ability to organize work efforts, prioritize tasks, and utilize appropriate resources to deliver work products in accordance with timelines and regulations.
• Decision-making: utilizes knowledge, networks, and data to make rapid and informed decisions.
• Business operations/knowledge of field: demonstrates knowledge of regulations and applies this understanding to optimize daily activities and ensure functional areas within R&D are compliant with regulations and procedures.

This role offers an exciting opportunity to contribute to the success of the organization by maintaining and improving our quality assurance capabilities.