Technical Director – Cacém

Description

Job Summary: The plural+udifar is seeking a Technical Director to ensure regulatory compliance, quality, and safety of products in pharmaceutical distribution. Key Highlights: 1. Join a solid and transforming organization. 2. Collaborative environment with autonomy and continuous learning. 3. Opportunity to be part of a team that cares for People. **plural+udifar**, a reference in the pharmaceutical distribution sector, is seeking a Technical Director who wishes to assume a central role in ensuring quality, safety, and technical integrity of a continuously evolving pharmaceutical operation. **Location:** Cacém Platform – Lisbon **Mission:** Ensure the technical and regulatory compliance of pharmaceutical distribution activities, guaranteeing adherence to Good Distribution Practices (GDP), as well as product quality and safety, and the effectiveness of the Quality Management System (QMS), promoting continuous operational improvement. Also responsible for the regulatory framework and compliance of private-label services and products, ensuring coordination with regulatory authorities. **Responsibilities:** * Ensure compliance with Good Pharmaceutical Distribution Practices, Technical Directorate directives, and applicable regulations from INFARMED, DGAV, and other regulatory authorities, guaranteeing legal and technical compliance of all operations. * Support the implementation, maintenance, and continuous improvement of the Quality Management System (QMS), promoting the effectiveness of technical and operational processes and alignment with applicable regulations. * Ensure the company’s regulatory compliance by monitoring legislative developments and market best practices, in coordination with operational and commercial departments, guaranteeing regulatory compliance, product quality and safety—including private-label products and medical devices. * Coordinate and monitor environmental parameters across the entire distribution chain, ensuring maintenance of regulatory limits defined in Good Distribution Practices. * Supervise timely product recalls, ensuring effective communication with customers, suppliers, and competent authorities. * Manage technical complaints, ensuring investigation, root cause analysis, and implementation of corrective and preventive actions. * Represent the company institutionally before regulatory and sectoral authorities, ensuring effective technical communication and defense of organizational interests, as well as participating in external inspections and audits, developing action plans and ensuring their implementation. * Collaborate in planning, executing, and evaluating the effectiveness of training on Good Distribution Practices, ensuring continuous staff updates. * Ensure management and updating of safety data sheets for marketed products (where applicable), guaranteeing full documentary compliance. * Supervise management and compliance of EMMs (Electronic Medical Records/Materials) in logistics platforms, ensuring traceability and documentary control. **Profile:** * Master’s degree in Pharmaceutical Sciences, registered with the Portuguese Pharmaceutical Society (mandatory); * Minimum of 3–5 years’ professional experience in similar roles, notably Technical Direction and Regulatory Affairs (preferred); * Advanced certification in Good Distribution Practices – MUH, MUVET, DMs and Cosmetics (advantageous); * Knowledge of applicable regulatory legislation and NP-EN ISO 9001:2015 (advantageous); * Familiarity with INFARMED and DGAV platforms; * Experience interacting with regulatory authorities, external audits and inspections (advantageous); * Strong technical analytical ability, decision-making capacity, and priority management skills; * Excellent communication and interpersonal relationship skills; * High sense of responsibility, rigor, and attention to detail; * Residence in the Lisbon region. **We Offer:** * Integration into a solid organization with over 51 years of history and undergoing significant transformation; * Collaborative environment offering autonomy, continuous learning, and room for growth; * Opportunity to join a team that cares for, empowers, and celebrates People—the core of everything we do; * Competitive benefits package. **Here, Technical Direction has voice, impact, and future. Join us!**