Department : Quality Assurance Location : Co.
Tipperary, Ireland Reports to : Head Quality / QP Job Summary The Senior Manager plays a key leadership role in ensuring that pharmaceutical products are developed, manufactured, tested, and released in full compliance with global regulatory requirements (FDA, EMA, ICH, etc.) and internal quality standards.
This position provides strategic oversight of Quality Assurance (QA) Operations, contributing to both operational excellence and continuous improvement initiatives.
The Associate Quality Director partners cross-functionally with Manufacturing, R D, Regulatory Affairs, and Supply Chain to deliver safe, effective, and high-quality products to patients worldwide.
Key Responsibilities Technical Responsibilities · Oversee quality systems including IPQA, Validation, Training, Document control Batch certification, Material procurement and release to support the operation Quality element for Long range plan of site · Ensure compliance with cGMP, ICH guidelines, FDA/EMA regulations, and other applicable international standards.
· Lead internal (regulatory inspections, customer audits, supplier audits) and support in Regulatory audit and act as primary interface when required.
· Drive implementation and continuous improvement of Quality Management Systems (QMS) in Operation QA activities to support continuous and compliant production supplies for commercial.
· Review and approve quality documents such as SOPs, protocols, reports, validation documents.
· Provide technical guidance to operation QA team and also other quality function where required.
· Monitor and evaluate performance of Operation QA to ensure data integrity and reliability.
Strategic and Leadership Responsibilities · Develop and execute departmental goals aligned with corporate quality strategy and long-range · plan.
· Collaborate with regulatory, operations, and R D to support new product introductions and lifecycle management.
· Lead and mentor team members, supporting staff development and succession planning.
· Represent the Quality function in executive meetings and cross-functional leadership teams.
Participate in risk assessments and mitigation planning for quality and compliance issues Requirements Professional Interpersonal Skills · Strong leadership with proven ability to manage and motivate cross-functional teams.
· Excellent communication and presentation skills to influence stakeholders at all levels.
· Analytical and problem-solving mindset with attention to detail.
· Effective project management and organizational skills.
· Ability to balance compliance requirements with business needs in a fast-paced environment.
· High integrity and ethical standards, with a strong sense of accountability.
· Oversight of quality operations for inhalation manufacturing site supporting products in line with company long range plan for year .
· Manage quality team resource planning and utilisation, including managers, supervisor, associates, professional and contractor in line with approved budget and develop cost saving elements.
· Lead or support audits annually (internal, regulatory, customer).
· Reduce batch release cycle time through continuous improvement initiatives.
· Track and trend key quality metrics (e.g., Batch RFT, Validation Execution, Training) with monthly/quarterly reporting to executive leadership.
· Foster a culture of quality and continuous improvement across the organization.
· Proactively identify compliance risks and implement sustainable corrective actions.
· Serve as a quality champion during regulatory inspections and cross-functional projects.
· Mentor high-potential employees and contribute to talent development in the quality function.
· Advocate for patient safety and product integrity in all decision-making processes.