About PCI
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.
Position Overview
Working within the Quality function for PCI Pharma Services (Ireland Sites), the 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. They will be agile and customer-focused, with a proven talent for identifying the quality needs of the project and ensuring regulatory compliance through the project/programme lifecycle.
Key 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 to provide consultative support on quality-related issues and documentation management.
* Ensure that operational instructional documentation is up to date, compliant, and supports efficient production.
* Main point of contact for all quality escalations from customers.
* Ensure that products are packaged and controlled to meet requisite safety, quality, and GMP standards.
* Communicate regularly and effectively, working cross-functionally to ensure communication within the business is always up-to-date.
* Work closely with the Programme/Project Manager and cross-functional teams to define the programme strategy, scope, and objectives.
* 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, encouraging individuals to contribute to the success of each project.
* Manage risks within the programme, ensuring 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 various project teams from concept to handover.
* Manage change at varying levels, ensuring site procedures are followed and change controls are raised at the appropriate time.
* Create and sustain a working environment that promotes the PCI Values and Behaviours.
* Undertake tasks and manage specific or ad hoc projects as required to meet department and business needs.
* Work with customers to define KPIs and lead reporting of KPIs to Site and Customer Teams.
* Adhere to the company’s SOPs, Health & Safety, cGMP, and other regulatory guidelines.
* Responsible for the quality element of all new products and their associated project phases.
Join Us
Join us and be part of building the bridge between life-changing therapies and patients.
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.
Diversity, Equity, and Inclusion (DEI)
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.
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