Gerência de Garantia de Qualidade - Divisão de Farmacêuticos Estabelecidos (EPD) - São Paulo/SP
On-siteSão Paulo, São Paulo, Brazil
Job Summary
Ensure execution of audits, manage deviations, and support continuous improvement initiatives for GCP and GLP compliance across pre-clinical and clinical development phases. Represent QA GCP in clinical study teams, monitor studies throughout their lifecycle, and lead investigator site, Trial Master File, and Data Management audits for Phase I-IV studies. Prepare quality documents including study-specific QA plans based on risk assessment and protocol requirements. Create and maintain audit schedules, conduct internal system audits, and lead inspection readiness activities for Health Authority inspections. Provide advice, training, and oversight on regulatory environments and significant event investigations while reporting quality metrics. Requires a Master's degree in life sciences, 10+ years in pharmaceutical quality systems leadership, and 5+ years in clinical research. Located in São Paulo with 20% travel.
Required Qualifications
- Master's degree in a life science-related discipline or equivalent level of education in a relevant scientific/technical discipline such as Chemistry, Pharmacy, Biology, Microbiology, Engineering
- At least 10 years in the pharmaceutical industry
- A minimum of 7 years' quality systems leadership in highly regulated environment
- At least 5 years in clinical/pre-clinical research leading function or GCP Quality Assurance
- Extensive knowledge of international and local quality system and compliance legislations and standards
- Good communication and consultancy skills
- Decisive, hands-on mentality
- Strong interpersonal skills
- Able to manage effectively relevant topics with various interfaces including Health Authorities (Inspectors, Regulatory bodies)
- Analytical and strategic thinking
- Risk-based thinking
- Flexibility
- Problem-solving
- Good command of the English and Spanish language, both spoken and written
- Yes, 20% of the Time (Travel)
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