Quality Operations Manager FT, Stamullen
Client: PCI Pharma Services
Location: Stamullen
Job Category: Other
EU work permit required: Yes
Job Reference: 53c5f3d48e18
Job Views: 3
Posted: 22.07.2025
Expiry Date: 05.09.2025
Job Description:
Join PCI Pharma Services in a role that offers the opportunity to impact lives through life-changing therapies, with a global reach connecting biopharma companies and patients.
About Us: PCI is committed to making an impact by investing in people who drive progress and innovation. We aim to build dynamic teams across our global network to shape the future of healthcare.
Role Summary:
The Quality Operations Manager is a key member of the Quality Leadership Team, responsible for leading the QA Operations team, ensuring quality standards are met across departments, and managing processes related to batch lifecycle, facilities, and cleaning from a quality perspective at PCI Ireland Pharma Services. This position offers a significant opportunity for succession planning within the QA organization.
Responsibilities:
* Manage the generation and review of all batch manufacturing records, ensuring timely completion during production start-up and post-batch review.
* Oversee quality activities in the incoming goods receipt area.
* Communicate quality strategy to leadership and collaborate with departments to ensure understanding and adherence to quality requirements.
* Ensure all quality operations meet client expectations and regulatory requirements (HPRA/FDA), including facility, equipment, CSV, processes, and data integrity.
* Define and monitor Quality Operations KPIs and batch schedules, utilizing SQDC to manage quality operations and report weekly to the Quality Director.
* Review and approve deviations and investigations, and respond to customer queries related to product investigations.
* Lead and develop the Quality Operations team, including training, coaching, and managing HR activities.
* Participate in site leadership meetings, flagging operational concerns and collaborating with other departments to ensure quality compliance and risk management.
* Host customer inspections and support authority audits as needed.
* Drive continuous improvement and uphold good practices across the site, fostering a culture of quality.
Be part of our mission to bridge life-changing therapies to patients worldwide.
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