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Location

Northern Ireland | United Kingdom

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Job description

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.

Main purpose of job:

Working within the Quality function for PCI Pharma Services (Ireland Sites) the Quality Product(s) Lead will be primarily responsible for managing the quality element of New Product Introduction (NPI) relating to one customer Client in particular on a large scale programme consisting of one or more projects, each with varying complexity. 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.

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 stake-holders 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 the assigned customer.
• 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 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 execution.
• 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

Scope and Authority:

• 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 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.

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

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, 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.

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Salary