Get AI-powered advice on this job and more exclusive features.Direct message the job poster from CareerWise RecruitmentA Director of Quality Assurance is required by CareerWise Recruitment for our Galway based client. Recruiting for a seasoned Director of Quality Assurance, one who can take responsibility for the QP team, batch releases, IRs &CAPAs, i.e. they will focus on Quality Operations. This person will need to have Led Teams previously and be able to develop the capability within quality. They will need to be a confident decision maker, as well as comfortable with dealing with Regulatory Authorities for audits and presenting to senior leadership above country. You will be responsible to lead and oversee two critical functions within the Quality Assurance (QA) organization: the Batch Release Team and the Investigations & Corrective and Preventive Actions (CAPA) Team.Critical to being successful in this role is it is on-site and Sterile Manufacturing experience!Role of this positionProvide strategic and operational leadership to the Batch Release and Investigations/CAPA teams, aligning with corporate objectives and global regulatory standards (FDA, HPRA, DERKA, etc.).Manage the teams activities and develop strong decision makers and mentor site, fostering a culture of accountability, collaboration, and quality excellence. Direct quality oversight of product release processes, change control, CAPA, deviation management, and risk assessments.Oversee the implementation and maintenance of the Quality Management System (QMS), serve as a senior Quality Approver.Lead inspections and audits by regulatory authorities and ensure audit readiness at all times.Manage self-inspection programs, to proactively drive continuous improvement initiatives in QA systems and processes.Ensure robust documentation control, including management of batch records, standard operating procedures (SOPs), and quality manualsCollaborate cross-functionally with Manufacturing, Quality Control, R&D, Regulatory Affairs, Supply Chain and Global verticals to ensure cohesive quality operations.Monitor, analyze, and report quality metrics and key performance indicators (KPIs) to senior leadership, driving data-informed decision-making.Lead, mentor, and develop the Quality Assurance (QA) team to support a high-performance and continuous improvement culture.JOB REQUIREMENTSBachelors of Science (Pharmacy, Chemistry, Microbiology or related field), Advanced degree (M.S., Ph.D., MBA) preferred.Regulatory Knowledge: Strong understanding of Annex I, US, and EMA GMP regulations, with practical experience in regulatory audits.Aseptic manufacturing expertise, proven experience in contamination control strategiesMinimum 10 years of experience in the pharmaceutical industry with a strong understanding of sterile drug manufacture and cGMP requirementsDemonstrated ability to manage multiple strategic and operational priorities in a fast paced environmentStrong problem solving and critical thinking skillsExcellent communication, writing, presentation and data organisation skillsDemonstrated interpersonal and leadership qualitiesSeniority levelSeniority levelDirectorEmployment typeEmployment typeFull-timeJob functionJob functionQuality Assurance and EngineeringIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at CareerWise Recruitment by 2xGet notified about new Director of Quality Assurance jobs in Galway, County Galway, Ireland.Galway, County Galway, Ireland 2 weeks agoWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr