QA Operations Senior Manager

Cashel - Ireland

Salary: Not Disclosed

Experience Required: 5years

Posted on: 23 hours ago

Vacancies: 1 Vacancy

Job Summary

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.

Required Skills:

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.

Department: Quality Assurance Location: Co. Tipperary Ireland Reports to: Head Quality / QPJob SummaryThe 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 E...