NPI Quality Lead

2 weeks ago

Dublin, Dublin City, Ireland PCI Pharma Services Full time

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.

Job Title: NPI Quality Lead

Location: Stamullen, County Meath

Type: Permanent, Monday to Friday

Summary Of Role

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 strong 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.

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 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. Work cross-functionally to ensure communication within the business is always up-to-date and utilizes all available channels.
  • 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. Encourage individuals to contribute to the success of each project.
  • 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.
  • Create and sustain a working environment that promotes the PCI Values and Behaviours.
  • Undertake 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.
Essential Knowledge / Skills & Experience
  • Bachelor's or associate degree or Diploma / Certificate in Science, Engineering, or a related discipline. Experience may substitute for educational requirements.
  • 5 years' experience working in a Quality pharmaceutical role.
  • Proven track record of delivering results 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 a Pharmaceutical packaging organization.
  • Experience of managing a technical/quality team.
  • Occasional travel may be required for company business.
Skills
  • Demonstrable experience within New Product Introduction (NPI) and Quality governance.
  • Experience of quality critical activities within the pharmaceutical industry.
  • Sound working knowledge of cGMP.
  • Experience working directly with customers as the single point of contact.
  • Management level experience within a similar environment is an advantage.
  • Strong insight into pharmaceutical customer requirements relating to speed to market, NPI, and service.
  • Proficient in software packages such as Excel, Word, PowerPoint, Project, and Visio.
Equal Employment Opportunity (EEO) Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate based on any protected status.

At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company's purpose: Together, delivering life-changing therapies.

Seniority Level

Mid-Senior level

Employment Type

Full-time

Job Function

Quality Assurance

Industries

Pharmaceutical Manufacturing

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