QA Operations Senior Manager

Department :Quality Assurance
Location: Co. Tipperary, Ireland
Reports to: Head Quality / QP

Job Summary

The SeniorManager plays a key leadership role in ensuring that pharmaceutical productsare developed, manufactured, tested, and released in full compliance withglobal regulatory requirements (FDA, EMA, ICH, etc.) and internal qualitystandards. This position provides strategic oversight of Quality Assurance (QA)Operations, contributing to both operational excellence and continuousimprovement initiatives. The Associate Quality Director partnerscross-functionally with Manufacturing, R&D, Regulatory Affairs, and SupplyChain to deliver safe, effective, and high-quality products to patientsworldwide.

Key Responsibilities Technical Responsibilities

• Oversee quality systemsincluding IPQA , Validation , Training , Document control Batch certification,Material procurement and releasetosupport the operation Quality element for Long range plan of site
• Ensure compliance with cGMP,ICH guidelines, FDA/EMA regulations, and other applicable internationalstandards.
• Lead internal (regulatoryinspections, customer audits, supplier audits) and support in Regulatory auditand act as primary interface when required.
• Drive implementation andcontinuous improvement of Quality Management Systems (QMS) in Operation QAactivities to support continuous and compliant production supplies forcommercial.
• Review and approve qualitydocuments such as SOPs, protocols, reports, validation documents.
• Provide technical guidance tooperation QA team and also other quality function where required.
• Monitor and evaluateperformance of Operation QA to ensuredata integrity and reliability.

Strategic and Leadership Responsibilities

• Develop and executedepartmental goals aligned with corporate quality strategy and long-range
• Collaborate with regulatory,operations, and R&D to support new product introductions and lifecyclemanagement.
• Lead and mentor team members,supporting staff development and succession planning.
• Represent the Quality functionin executive meetings and cross-functional leadership teams.

Participatein risk assessments and mitigation planning for quality and compliance issues

Requirements Professional & Interpersonal Skills

• Strong leadership with provenability to manage and motivate cross-functional teams.
• Excellent communication andpresentation skills to influence stakeholders at all levels.
• Analytical and problem-solvingmindset with attention to detail.
• Effective project managementand organizational skills.
• Ability to balance compliancerequirements with business needs in a fast-paced environment.
• High integrity and ethicalstandards, with a strong sense of accountability.
• Oversight of quality operationsfor inhalation manufacturing site supporting products in line with company longrange plan for year .
• Manage quality team resourceplanning and utilisation, including managers, supervisor, associates,professional and contractor in line with approved budget and develop costsaving elements.
• Lead or support audits annually(internal, regulatory, customer).
• Reduce batch release cycle timethrough continuous improvement initiatives.
• Track and trend key qualitymetrics (e.g., Batch RFT, Validation Execution, Training) withmonthly/quarterly reporting to executive leadership.
• Foster a culture of quality andcontinuous improvement across the organization.
• Proactively identify compliancerisks and implement sustainable corrective actions.
• Serve as a quality championduring regulatory inspections and cross-functional projects.
• Mentor high-potential employeesand contribute to talent development in the quality function.
• Advocate for patient safety andproduct integrity in all decision-making processes.