Project Manager Quality Control/Validation
We are seeking an experienced project manager with expertise in quality control and validation to join our expanding operations in Ireland.
Key Responsibilities:
* Lead and coordinate quality control and validation projects, ensuring timely execution and compliance with industry regulations.
* Oversee equipment qualification activities, including design evaluations, factory acceptance testing (FAT), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
* Develop and maintain project plans, schedules, and budgets to ensure alignment with business objectives.
* Act as the primary point of contact between clients, internal teams, and external vendors to drive project success.
* Manage documentation related to quality control and validation, including test outlines and procedures (TOPs), qualification summary reports (QSRs), and change controls.
Position Requirements:
* Bachelors or masters degree in engineering, life sciences, or a related field.
* 8+ years of experience in project management, quality control, or validation within the pharmaceutical, biotech, or life sciences industries.
* Experience with regulatory compliance standards (GMP, FDA, EU Annex 15, ISO) and industry best practices.
* Strong leadership and communication skills, with the ability to manage multiple stakeholders and drive project success.
About CAI
CAI is a 100% employee-owned company established in 1996, growing year over year to nearly 700 employees worldwide.
We provide commissioning, qualification, validation, start-up, project management, and consulting services related to operational readiness in FDA-regulated and other mission-critical industries.
Our approach is simple: we put the clients interests first, we do not stop until it is right, and we will do whatever it takes to get there.
We act with integrity, serve each other, serve society, and work for our future. With employee ownership, one persons success is everyones success.
We work diligently to accomplish team goals, place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude.
That is how we have grown exponentially.
CAI professionals are exposed to cutting-edge technologies in the advanced medicine space, working alongside recognized subject matter experts.
We invest in YOUR future through hands-on certifications and professional training.
As part of our culture, you will be part of a team that values integrity, innovation, and long-term success.
If you are a motivated professional with a passion for quality and project management, we encourage you to apply.