Director of Quality Excellence

Quality Assurance Director

We are seeking a seasoned Quality Assurance Director to join our team.

A highly experienced professional with over 15 years of experience in the pharmaceutical industry, specializing in controlled, biosimilar and bioequivalent products, with a proven track record in total quality management (TQM) and compliance with national and international regulatory regulations.

The ideal candidate will have extensive international exposure leading operations in highly regulated markets such as the U.S., Europe, Japan and Latin America.

You will be responsible for the clinical area, with experience in the design, implementation and monitoring of clinical studies for biopharmaceutical and controlled products, ensuring compliance with GCP and local and international ethical regulations.

Leading expertise in the development and implementation of global regulatory strategies, design of robust quality systems under GxP STANDARDS (GMP, GDP, GLP), and implementation of risk management systems in accordance with ICH Q9.

Proven track record in obtaining and maintaining health registrations for complex pharmaceutical products, including biologics, biosimilars, and high-surveillance molecules.

The successful candidate will lead regulatory audits, manage multidisciplinary teams in multicultural environments and ensure the strategic alignment of quality with business objectives.

Key Responsibilities :

• Ensure products and processes comply with quality standards by establishing and enforcing quality requirements.
• Prepare quality reports of processes and products by collecting, analyzing, and summarizing information and trends.
• Serve as the main point of contact with regulatory authorities and lead scientific advice / consultation meetings.
• Lead the development and implementation of regulatory strategies to secure product commercialization.
• Establish the renewal schedule for registrations and new products.
• Ensure Pharmacovigilance activities are conducted in accordance with all applicable regulations.
• Lead the development of Risk Management Plans, their implementation, and assessment of effectiveness.
• Design response strategies for inquiries from ethics committees and health authorities regarding safety.
• Act as Qualified Person (Responsable Sanitario) for the QC Laboratory and head of the clinical area.

Requirements :