Quality Product Lead

PCI Pharma Services; Ireland; On-site; EUR 70,000 - 90,000; Full time

Job summary

A leading pharmaceutical company in Ireland is seeking a Quality Product Lead to manage quality aspects of New Product Introduction projects. You will ensure compliance with all regulatory standards, promote team engagement, and maintain strong relationships with clients. The ideal candidate will have extensive experience in pharmaceutical quality governance and team management, with a strong understanding of cGMP and medical device assembly, aiming to foster an environment of quality and operational excellence.

Benefits

Fair and competitive rewards program

Intentional learning opportunities

Qualifications

• 5 years' experience in Quality pharmaceutical or medical device role.
• Experience in managing a technical/quality team.
• Strong insight into pharmaceutical customer requirements.

Responsibilities

• Ensure compliance with cGMP and regulatory standards.
• Promote engagement at all levels of the program.
• Lead project teams from concept to handover.

Skills

New Product Introduction (NPI)

Quality governance

cGMP compliance

Medical device assembly

Team management

Lean Manufacturing

Education

EQF level 6 in Technical, Engineering or Science

Job description

We are now looking for a **Quality Product Lead** (Permanent role) to join our team in Stamullen, County Meath.**Summary of Role** Working within the Quality function for PCI Pharma Services (Ireland Sites) Quality Product(s) Lead will be primarily responsible for managing the quality element of New Product Introduction (NPI) and large-scale programmes relating to one Client consisting of one or more projects, each with varying complexity or multiple products within the NPI portfolio. A sound collaborator and natural leader, the Quality Product(s) Lead will display interpersonal and communication skills that build the strongest of relationships at site and customer levels. Whilst agile and customer focused, they will be a proven talent for identifying the quality needs of the project and ensuring regulatory compliance through the project/programme lifecycle. Quality Product(s) Lead will have a proven track record in the ability to communicate and escalate effectively, be strong in team management and possess excellent coordination skills.**Key Responsibilities** Ensure compliance with cGMP, corporate standards/PCI Quality System (PQS), site policies/procedures, regulatory requirements, and industry standards.Promote engagement at all levels and stages of the programme. Encourage individuals to contribute to the success of each project and illustrate benefits brought about. * Follow and comply with the NPI process as per company procedures and policies.* Display strong leadership to the various project teams from concept to handover. Lead by example in day-to-day project and team management.* Manage change at varying levels ensuring site procedures are followed and change controls are raised at the appropriate time with the relevant approvers engaged from the outset.* Create and sustain a working environment that promotes the PCI Values and Behaviours.* Work with Customer to define KPI’s and lead reporting of KPI’s to Site and Customer Teams.* Quality Product(s) Lead is responsible for adhering to the company’s SOPs, Health & Safety, cGMP and other regulatory guidelines themselves and for team members and contractors under their control.* Quality Product(s) Lead is responsible for the quality element of all new products/devices and their associated project phases.* It is a requirement of this role that on occasion the individual will be required to travel on company business. This may be vendor/supplier or customer based.**Knowledge / Skills & Experience****Essential:*** To have demonstrable experience within New Product Introduction (NPI) and Quality governance of same.* To have experience of medical device assembly.* Experience of quality critical activities within the pharmaceutical industry.* Sound working knowledge of cGMP.* Experience of working directly with customers as the single point of contact.* Experience of working at management level within a similar environment an advantage.* Experience of managing a technical/quality team.To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities.Strong insight into the pharmaceutical customer requirements relating to speed to market, NPI and service.Industry knowledge of the requirements of EU GMP and ISO requirements for Medical Devices.5 years’ experience working in Quality pharmaceutical or medical device role. Educated to EQF (European Qualifications Framework) level 6 in a Technical, Engineering or a Science subject. Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.3 years experience working in Pharmaceutical packaging organisation or similar in medical device organisation.Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements. 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.