Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

We are looking for Quality Manager – Pharmaceutical Distribution to join our team in City North, Dublin, Ireland.

Main purpose of job:

Cultural:

A key member of the Quality Leadership Team that influences the wider organisation by demonstrating leadership through actions, accountability coaching and development of the Quality Operations, and function departments Quality work closely with. This role requires a self-starter who likes working with the freedom to manage their own area and take responsibility. This is a key succession planning opportunity within the QA organisation.

Technical:

The role of the Quality Manager is to lead the QA Warehouse Team. Define/improve the process with Quality Warehouse Operations. Responsibility for implementation and execution for the tasks relating to Goods in, Specifications, Storage, Pest Control, Dispatch, Cleaning/Housekeeping from a Quality perspective at PCI Ireland Pharma Services. Customer point of contact, working to ensure OTIF of batch Release/Dispatch and Customer commitments. Key QA member for introduction of new warehouse, set up of Systems, Risk Assessments, and transfer of product between sites.

Main responsibilities:

• Manage the Team that generates and reviews of all warehouse records within the business unit as part of Goods In & Dispatchactivities, ensuring agreed timelines are met.

• Direct quality activities within the incoming goods receipt area.

• The Quality Manageris responsible for communicating the strategy to Quality leadership and working closely with all functional departments to ensure the Quality WarehouseOperational requirements are understood and ultimately adhered to.

• Ensure Reject Forms, Specifications, Acetates, Calibration are all in control for Warehouse activities.

• Define Quality Warehouse Operations KPI’s, andschedules. Utilise SQDC to manage operations for quality and provide weekly summary of SQDC outputs to Quality Director.

• Review and approve deviations and investigations arising from the process or related to the storage, and dispatch in the business unit and respond to customer queries related to product investigations.

• Manage theQuality Warehouse Operations team. Train, develop, coach the team on the incoming goods, Events, Deviation, Non Conformance systems, documenting, and execution. Manage HR related activities. Complete Quantum for Team and yourself in a timely manner ensuring 1:1 conversation happen on time and team is aware for expectations.

• The Quality Manager is a key member of the Quality SiteLeadership team. In that capacity the incumbent must flag concerns with site Operations should any be found, work with other departments (Engineering, Production, NPI, QC and others) to ensure the Quality Operation needs are understood. Quality Operations department must utilise risk methodology, be pragmatic, solution orientated with overall focus on Quality compliance across the sites.

• Host Customer inspections (audits), visits and support HA authority inspections as required.

• Be a Leader, continue to drive good practice (cultural and technical) across the site, and continually improve the Quality system.

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)

Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled