Direct message the job poster from Baker Finn Recruitment
Job Title:
Quality Manager/Responsible Person - Ireland
Department:
QA
Manager:
Director, QA
Company Overview:
At our client, their purpose is to improve the lives of patients. We accomplish this by offering Clinical Trial Supply Chain Services and Pharmaceutical Procurement globally. With offices in Canada, the USA, and Ireland, we deliver tailored services to Pharmaceutical Sponsors, Biotechs, and CROs. Our team and culture are our most valuable assets, embodying our core values in everything we do. We see our clients as partners, and their success is our success.
Position Summary
The Quality Manager/RP - EU oversee all activities in the Quality department within Europe and will ensure the implementation and continued development of the Quality Management Systems of all the clients divisions (Sourcing, Clinical Trial Services, Distribution, Medical Devices, and Regulatory Affairs). The person in this role will work closely with the global QA team to ensure processes are harmonised across the three client sites.
This is a pivotal leadership role that requires the candidate to have proven Quality experience, strategy, strong communication and analytical skills to fulfill client’s vision, mission and values.
Responsibilities:
* Maintain compliance to all relevant standards and legislative requirements pertinent to EU regulations
* Manager all RP related tasks functions to ensure compliance.
* Foster, lead and embed a strong culture of quality in our client.
* Lead and develop the quality team at the Ireland location
* Work with the global QA team to implement an Electronic Quality Management System and continued development of Integrated Management Systems
* Manage all RP related responsibilities.
* Manage regulatory, customer and vendor inspections
* Ensure that initial and continuous training programs are implemented and maintained within all divisions of the organisation
* Manage the Change Control process, ensuring controlled implementation of all GxP related changes in accordance with relevant SOP’s
* Review and approve Corrective and Preventive action (CAPA), including tracking, follow-up, and evaluating CAPA effectiveness.
* Lead and manage the QA responsibilities under the Manufacture and Importation Authorization
* (MIA) including Qualified Person (QP), ensuring implementation and continued development of the quality system and good manufactures practices (GMP)
* Lead and manage the QA responsibilities for the Packaging and Labelling activities, ensuring implementation
* Conducts validation/qualification of GMP Equipment/Systems/Facilities
* Communicate frequently with all the departments to ensure information flows seamlessly (QA, Logistics, Project Management, Sourcing, Purchasing, Operations, HR and Regional Teams etc.)
Your experience, skills and qualifications:
* 3+ years of QA experience in clinical trials, pharmaceutical or medical devices
* Must have RP experience.
* Solid knowledge of European regulations and guidelines
* A Diploma or Degree from a recognized College or University or equivalent working experience
* Proficient in MS Office - including Outlook, Word, Excel, PowerPoint, OneNote, Teams
* Supervisory experience preferred
* Experience working with Electronic Quality Management Systems (e.g. TrackWise, etc.)
* Professional level grammar and excellent proof-reading skills
* Excellent communications skills (verbal, written, listening, conveying messages)
* Detail-oriented
* Highly adaptable, flexible professional who embraces teamwork, but also enjoys working independently
* Experience working with colleagues across different Global time zones
* Willingness and flexibility to travel as required
No matter your role at the client, successful team members are:
* Patient Champions, who put patients first and uphold strict ethical standards
* Achievers, who drive toward practical solutions
* Individuals Who Inspire Excellence in themselves and those around them
* High-quality and accountable executors, working towards goals and milestones with quality, precision, and speed
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Transportation, Logistics, Supply Chain and Storage and Pharmaceutical Manufacturing
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