The Role: PE Global are recruiting for a QA Sr. Manager to be based in Dun Laoghaire 12 Month initial contract Description Quality and Compliance Oversight of a contract lab, CMO or a raw material SME. Alignment with CTA / Marketing Application. Key Responsibilities Be an integral quality member of cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development, supply chain XPD etc. Negotiator and Approver of quality agreements Lead the preparation of the site for and Represent at product-specific Regulatory Inspections and/or during Notified Body audits of CM Site, as applicable or required. Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areas Review / Approve Master Batch Records Quality approver for deviations, change controls, CAPA Prepare inspection playbooks Identify and mitigate Risk at the CMO or testing Laboratories and/or escalate to management Perform Person in Plant activities as required APR Data Provider Manage Audit commitments to completion Perform tactical batch disposition activities in support of lot release Authority Decision to release or Reject batches (Dynamic is different for SREs) Decision to approve or reject deviations, Change Control, CAPA Decision to approve QAGR Provide Quality position on GMP related topics and strategy for the site Decision to approve Master batch Records/Raw Material Specifications Basic Qualifications: Doctorate degree & 2 years of directly related experience OR Masters degree & 4 years of directly related experience OR Bachelors degree & 6 years of directly related experience OR Associates degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience Preferred Qualifications: Preferred Requirements: 10 + years biotech or pharmaceutical industry experience Additional European Languages - desirable not essential Significant Quality experience at Aseptic Manufacturing facilities Able to facilitate and influence senior stakeholders and partners Able to successfully manage workload and timelines Familiarity with basic project management tools Ability to negotiate a strategic position after taking feedback from multiple sources Strong project management, problem-solving, and analytical skills Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution Ability to operate in a matrixed or team environment with site, functional, and executive leadership Experience driving decision making by using DAI principles Experience with the variation management process Interested candidates should submit an updated CV. Please click the link below to apply, call Audrey Mccarthy on or alternatively send an up to date CV to Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: qa cmo external manufacturing