Associate Director, NPI Quality

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 Associate Director – New Product Quality will be primarily responsible for managing the quality element of New Product Introduction (NPI) and large-scale programmes consisting of several projects, each with varying complexity. A sound collaborator and natural leader, the Associate Director – New Product Quality will display interpersonal and communication skills that build the strongest of relationships at site, global and customer levels. Whilst agile and customer focused, they will be a proven talent for identifying the quality needs of the project upfront and ensuring regulatory compliance through the project/programme lifecycle.

The Associate Director – New Product Quality will have a proven track record in the ability to communicate and escalate effectively, be strong in team management and possess excellent coordination skills.

Location: Stamullen, IRL

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.
* Manage a high performing team of individuals within the business to deliver large scale high value programmes.
* Main point of contact for all NPI Quality escalations from Customers.
* Ensure products are packaged and controlled to meet the requisite safety and quality and GMP standards.
* Work cross functionally to ensure communication within the business is always up-to-date and utilises all available channels.
* Provide best in class service to our customers representing PCI in all engagement including on-site project reviews and steering meetings.
* Working cross-functionally, coordinate and evaluate resources assigned to ensure there is appropriate resource within the NPI quality team and that tasks are appropriately delegated and tracked to completion.
* Working with the programme and project managers manage project timelines to ensure 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.
* Prioritise delivery for our PCI’s global customer base with a focus on quality, Right First Time (RFT) and On Time in Full (OTIF).
* 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.
* Establish onboarding programmes for new team members and develop career progression pathways for each member of the team.
* Execute performance reviews on a regular basis and compile end of year reviews in accordance with company systems and timelines.
* 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.

Experience

* 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 collaborating directly with customers as the single point of contact
* Experience of working at management level within a similar environment an advantage
* Experience of managing a technical/quality team

Qualifications & Training

Educated to EQF (European Qualifications Framework) level 6 in a Technical, Engineering or a Science subject.

Master’s degree (or higher) in a Technical, Engineering or a Science subject.

Proficient utilisation of software packages such as Excel, Word, PowerPoint, Project and Visio and a high level of computer literacy.

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.

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