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 a NPI Quality Lead (Permanent role) to join our team in Stamullen, County Meath. This is a Monday to Friday position.
Summary of Role:
Working within the Quality function for PCI Pharma Services (Ireland Sites) NPI Quality Lead will be primarily responsible for managing the quality element of New Product Introduction (NPI) of multiple projects and products. A sound collaborator and natural leader, the NPI Quality 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.
NPI Quality 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.
Main Responsibilities:
- Ensure compliance with cGMP, corporate standards/PCI Quality System (PQS), site policies/procedures, regulatory requirements, and industry standards.
- Partner closely with customers and stakeholders to understand and deliver on all records within timelines and escalate when necessary.
- Participate in cross functional teams as required to provide consultative support on quality related issues and documentation management.
- Ensure that operational instructional documentation are up to date, compliant, and supports efficient production.
- Main point of Contact for all Quality escalations from Customers.
- To ensure that products are packaged and controlled to meet the requisite safety and quality and GMP standards.
- Communicate regularly and effectively. Work cross functionally to ensure communication within the business is always up-to-date and utilises all available channels.
- Work closely with the Programme/Project Manager and cross functional teams to define the programme strategy, scope and objectives.
- Working with the programme and project managers manage project timelines to ensure Quality elements of projects are delivered on time and critical paths are identified and monitored throughout their lifecycle.
- 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.
- Manage risks within the programme. Ensure risks are identified, evaluated, and controlled through the programme lifecycle.
- 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.
- 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.
- Work with Customer to define KPI’s and lead reporting of KPI’s two Site and Customer Teams
- NPI Quality 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.
- NPI Quality Lead is responsible for the quality element of all new products and their associated project phases.
Knowledge / Skills & Experience
Essential:
- Bachelor’s or associate degree or Diploma / Certificate in Science, Engineering or a related discipline. May substitute experience in lieu of educational requirements.
- 5 years’ experience working in Quality pharmaceutical role.
- Proven track record of showing how results were delivered in Project based roles.
- Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
Desirable:
- 3 years’ experience working in Pharmaceutical packaging organisation.
- Experience of managing a technical/quality team.
- It is a requirement of this role that on occasion the individual may be required to travel on company business. This may be vendor/supplier or customer based.
Skills:
- To have demonstrable experience within New Product Introduction (NPI) and Quality governance of same.
- 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 is an advantage.
- Strong insight into the pharmaceutical customer requirements relating to speed to market, NPI and service
- Proficient utilisation of software packages such as Excel, Word, PowerPoint, Project and Visio and a high level of computer literacy.
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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.
At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
