Site Quality Director (Xochimilco)
Core
Ensure compliance with Organon Policies and global industry standards, establish processes for regulatory trends, and guarantee product quality, efficacy, and safety for pharmaceutical products.
Role type
Site Quality Director
Builds
Pharmaceutical products ensuring quality, efficacy, and safety
Domain
Pharmaceutical manufacturing and supply chain
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP, GxP, regulatory requirements, pharmaceutical manufacturing, supply chain management, internal audit management, data management systems, budget management, team leadership
Preferred skills
Master's degree in Pharmaceutical Sciences, Regulatory Affairs, Public Health, or Quality Assurance
Technologies
NOM-059-SSA1, SHE
Responsibilities
Ensure development and implementation of quality assurance policies and procedures; ensure product compliance with regulatory requirements including FDA guidelines; establish a culture of continuous improvement; manage internal audit processes; provide training and guidance on quality assurance procedures; establish effective data management systems; lead and empower the quality organization; manage financial resources and the quality area budget; act as the Responsible Health Officer before COFEPRIS; monitor and evaluate the effectiveness of quality systems and processes.
Seniority
Director level, executive role
