Senior Auditor, Quality Assurance

This is a fully remote position, open to applicants in Portugal.

📋 Description

• Oversee and perform internal and contracted audits for the Company and its Clients.

• Contribute to the development of audit strategies and risk-based audit planning.

• Lead complex and process audits.

• Offer QA consultancy in the area of GxP expertise.

• Execute audits of partners, vendors/service providers, internal systems, study files, investigational sites, and third parties.

• Manage activities leading up to audits.

• Review and endorse final CAPA plans within the required timelines.

• Conduct client PV/QMS system gap analyses and develop SOPs.

• Act as the primary QA contact for assigned Clients.

• Organize, perform, and report on audits requested by Clients.

• Participate in commercial meetings pertaining to Quality as a Service.

• Assist Clients with mock inspections, training, gap analysis, and drafting/revising procedures.

• Support audits and inspections conducted by Clients, third parties, and regulatory bodies.

• Develop and mentor Auditors and other quality personnel.

• Help in crafting the strategic internal audit program.

• Stay updated on international regulatory requirements, guidelines, and best practices.

• Engage in the authorship or quality control of audit strategies, SOPs, guidelines, and other procedures.

⛳️ Requirements

• A Bachelor’s degree in a scientific field is required; a Master’s degree is preferred, or equivalent relevant industry experience.

• Significant prior experience in pharmacovigilance within the pharmaceutical and/or biotech sectors.

• Strong comprehension of GVP and GCP related Quality Management and Assurance.

• Previous experience in an Audit Lead role focusing on GVP and GCP auditing.

• Excellent analytical, written, and oral communication skills.

• Capacity to manage assigned tasks and deliver expected outcomes in an organized and timely fashion.

• Ability to proactively communicate any changes to pre-established goals and deadlines.

• Strategic thinker with the capability to collaborate using risk-based, proactive problem-solving approaches.

• Strong team player.

• Fluent in English, both written and spoken.

• Proficiency in additional/local languages is advantageous but not mandatory.

🏝️ Benefits

• Availability of remote work.

• Collaborative team environment.

• Opportunities for career advancement and professional development.

• Knowledge-sharing and learning opportunities.

• Training opportunities.

• Diverse and inclusive workplace.

• Chance to positively impact patients’ lives.