Associate Director, Quality Operations

Emploi pas sur LinkedIn

🕒 il y a 1 mois

🏄 California – Distant

🏄 California – Remote

💵 $160 000 - $230 000 / an

⏰ Temps Plein

🟠 Senior

⚙️ Opérations

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Codera

Site WebLinkedInTous les Emplois

11 - 50 employés

🏥 Santé

💼 Conseil

📦 Logistique

Healthcare • Consulting • Logistics

Codera est une entreprise B2B qui collabore avec des entreprises de biotechnologie et pharmaceutiques pour fournir une expertise et une infrastructure complètes de développement de médicaments. Elle soutient ses clients tout au long du cycle de développement des médicaments avec des services techniques, opérationnels et d'infrastructure afin de faire progresser les programmes thérapeutiques.

Description

• Perform vendor assessment of operational GxP systems (remote or onsite), including qualification and re-qualification. • Manage vendor inspection readiness program, including status for audit related CAPA and inspection readiness workstreams for GXP activities. • Utilize metrics and work plan to track and continually improve performance of quality operations workstreams. • Responsible for the review of API, Intermediate, labeled finished product and other Executed Batch Records and perform QA release of batches, including raw data review to ensure batch release requirements are met. • Classify, process and support deviation and complaint investigations and evaluate resulting corrective and preventive actions with vendors. • Develop and issues communications and reports to stakeholders as required. • Ability to communicate real-time quality information on all ongoing quality operations activities to senior management and stakeholders. • Develop procedures and other quality operations related documents to establish a library for multiple company types. • Develop and deliver presentations to internal and external audiences. • Coordinate the Quality Risk Management process throughout development and lifecycle management of the Product. • Prioritize ongoing Quality Risk Management efforts and assign appropriate team members to risk management activities in collaboration with technical leads, management, and project management. • Ensure that improvements in the risk assessment process are constantly identified, prioritized, and implemented. • Establish, implement, and maintain a system of work standards within the framework of site procedures and regulatory guidance. • Lead and/or support other projects as assigned

🎯 Exigences

• Degree in any science related discipline • Minimum 10 years of experience in quality system implementation and/or execution of quality events across various pharmaceuticals or biologics • Minimum 6 years of experience in GxP service provision including management of various workstreams and/or customers • Previous experience with management of quality assurance and quality control systems including laboratories, document management and quality event management • Knowledge of GxP operations for clean rooms, facilities, and associated equipment • Ability to work in a dynamic environment with a high degree of flexibility • Previous audit experience • Strong critical thinking skills and ability to apply sound judgment and decision making based on risk and phase of development • Ability to manage multiple workstreams across multiple disciplines • Up to 20% of domestic and international travel required

🏖️ Avantages

• employer sponsored insurance plans including medical, dental and vision coverage • generous paid time off • retirement plan options • additional wellness and professional development programs