Quality Product Lead

Summary Of Role

Working within the Quality function for PCI Pharma Services (Ireland Sites), the Quality Product 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 Lead will display interpersonal and communication skills that build relationships at site and customer levels. While agile and customer focused, they will identify the quality needs of the project and ensure regulatory compliance through the project/programme lifecycle. The Quality Product 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.
• 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.
• Ensure products/devices are packaged and controlled to meet the requisite safety, quality and GMP standards.
• Communicate regularly and effectively. Work cross functionally to ensure communication within the business is up-to-date and utilizes all available channels.
• Work closely with the Programme Manager and cross functional teams to define the programme strategy, scope and objectives.
• With the programme and project managers, manage project timelines to ensure Quality elements are delivered on time and critical paths are identified and monitored throughout their lifecycle.
• Promote engagement at all levels and stages of the programme and encourage individuals to contribute to its success.
• 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 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 relevant approvers.
• 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 within the scope of the role.
• Work with Customer to define KPI's and lead reporting of KPI's to Site and Customer Teams.
• Adhere to the company's SOPs, Health & Safety, cGMP and other regulatory guidelines for self and team members and contractors under their control.
• Responsible for the quality element of all new products/devices and their associated project phases.
• Occasional travel on company business may be required (vendor/supplier or customer based).

Essential Knowledge / Skills & Experience

• Demonstrable experience within New Product Introduction (NPI) and quality governance of same.
• 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 at management level within a similar environment is an advantage.
• Experience of managing a technical/quality team.
• Strong insight into pharmaceutical customer requirements relating to speed to market, NPI and service.
• Industry knowledge of EU GMP and ISO requirements for Medical Devices.
• 5 years' experience in a Quality pharmaceutical or medical device role.
• Educated to EQF level 6 in a Technical, Engineering or Science subject.
• Master's degree (or higher) in a Technical, Engineering or Science subject.
• Proficient with software packages such as Excel, Word, PowerPoint, Project and Visio; high level of computer literacy.
• Commitment to safe work practices and reporting near misses to EHS.
• Ability to carry out additional tasks to meet company goals.

Desirable

• 3 years' experience in pharmaceutical packaging or medical device organisation.
• Experience in GMP or Regulated Environments.
• Experience in Lean Manufacturing and Lean tools for continuous improvements.

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, Equity and Inclusion 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.

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