Social network you want to login/join with:Title: QC Raw Materials and Compendial Associate DirectorLocation: DundalkDescription:As QC Raw Materials and Compendial Associate Director, you will be responsible for ensuring the highest standards of professional regulatory adherence, excellence, and quality within the business. You will have overall responsibility for managing QC instruments/equipment, analytical test methods for raw materials testing, managing raw materials specifications and release, sampling, and regulatory retain samples. You will lead product compendial testing and support various projects. Working closely with senior leaders, you will help develop the local QC strategy aligned with the global QC function.Department DescriptionYou’ll be joining an organization that respects diverse backgrounds and experiences, working together to change lives. You will report to the QC Director.ResponsibilitiesParticipate in strategy and business planning, ensuring cross-functional collaboration and leadership execution.Collaborate with senior leaders to meet work practices and targets aligned with business objectives.Represent the QC organization professionally with counterparts and business leaders.Support the design, construction, and commissioning of a new facility for drug substance production.Build and develop a world-class QC Raw Materials and Compendial testing team, including hiring, coaching, and training 8-15 staff.Oversee raw materials and compendial routine testing, method verification, and transfer.Manage QC instruments and equipment for raw materials and compendial testing.Handle raw materials sampling, log-in, disposition, and inventory of regulatory retention samples.Author technical documents, SOPs, testing protocols, reports, specifications, and expiry reports.Represent the team during regulatory inspections and audits.Lead investigations, deviations, change controls, and CAPAs.Coordinate with QC teams and other departments to support lab start-up and operations.Ensure safety in all tasks related to start-up and routine operations.Education and Experience:University degree in a related science or quality discipline is required.Doctorate with 5+ years or Master’s with 7+ years of relevant experience preferred.15+ years of experience in a GMP Quality Control environment, with extensive exposure to raw materials and testing.Proficiency in Microsoft Office and project management, with experience supervising personnel.Preferred:Experience with regulatory inspections and audits.Experience working in a CMO environment is a plus.Strong communication, troubleshooting, and problem-solving skills.Self-motivated, organized, detail-oriented, and adaptable to fast-paced environments.Ability to manage multiple priorities and deliver results.
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