Global QA Supplier Manager

Fastnet The Talent Group

Cork

This position reports to the Sr. Manager of Global Supplier Quality and will maintain Quality oversight of one or more areas of the Supplier Quality system. RESPONSIBILITIES. Plan, organize, and manage the functions of one or more areas of the Global Supplier Quality system, with respect to implementation and execution of policies and practices. Provide Quality Assurance review and/or approval for Supplier related activities impacting GxP operations, including and not limited to Changes, Deviations and Technical Agreements. Compile Supplier Performance metrics; including metrics for supplier changes, deviations, and other measures of supplier performance. Lead cross-functional Supplier Quality meetings. Develop Supplier related policies, and continuously evaluate and improve practices and systems to coordinate with validation, documentation, and regulatory systems. Strive toward constant improvement of systems in order to maintain compliance cGMP requirements for work performed. Provide support of Raw Material Specification review/approval. Represent Global Quality Assurance in multi-departmental meetings & project teams. Assist in development, implementation, and enforcement of departmental policies and practices. Participate in inspection preparation, train employees in inspection requirements and participate in regulatory inspections. Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured. Support CMC regulatory filings for all drug products. Other duties as assigned. REQUIREMENTS. BA or BS in a technical discipline (physical or biological sciences. 8 years experience in a GMP regulated environment, with exhibited knowledge and proficiency working within quality systems. 4 years experience in a management or supervisory position, with direct experience overseeing Supplier Changes preferred. Organizational and management skills, with ability to effectively plan, schedule, execute, and track complex projects. Ability to speak, present data, and defend approaches in front of audiences and inspectors. Ability to comprehend technical information related to regulatory expectations. Experience with cross functional project management. Experience in participation in regulatory inspections, with experience in presenting or defending departmental functions in audits or regulatory inspections preferred. Experience with TrackWise preferred. Experience working with international project teams preferred. Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent. Fastnet - The Talent Group. 'Not Just Placers.........Partners' The Life Science Specialists. This job originally appeared on RecruitIreland.com.

2253 days ago