About the job

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.

Summary of Role

The Quality Manager's role is to lead the QA teams at the CN, HCPF / Donore Road and Blanchardstown warehouses. This role will expand to include any new sites added in the future.

Key Responsibilities

Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department
Manage the Team that generates and reviews of all warehouse records within the business unit as part of Goods In & Dispatch activities, ensuring agreed timelines are met.
Direct quality activities within the incoming goods receipt area.
The Quality Manager is responsible for communicating the strategy to Quality leadership and working closely with all functional departments to ensure the Quality
Warehouse Operational requirements are understood and ultimately adhered to.
Ensure Reject Forms, Specifications, Acetates, Calibration are all in control for Warehouse activities.
Define Quality Warehouse Operations KPI’s, and schedules. Utilise SQDC to manage operations for quality and provide weekly summary of SQDC outputs to Quality Director.
Review and approve deviations and investigations arising from the process or related to the storage, and dispatch in the business unit and respond to customer queries related to product investigations.
Manage the Quality Warehouse Operations team. Train, develop, coach the team onthe incoming goods, Events, Deviation, Non-Conformance systems, documenting, andexecution. Manage HR related activities.
Complete Quarterly Conversations for Team and yourself in a timely manner ensuring 1:1 conversation happen on time and team is aware for expectations.
The Quality Manager is a key member of the Quality Site Leadership team. In that capacity the incumbent must flag concerns with site Operations should any be found, work with other departments (Engineering, Production, NPI, QC and others) to ensure the Quality Operation needs are understood. Quality Operations department mustutilise risk methodology, be pragmatic, solution orientated with overall focus on Quality compliance across the sites.
Host Customer inspections (audits), visits and support HA authority inspections as required.
Be a Leader, continue to drive good practice (cultural and technical) across the site, and continually improve the Quality system.
Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.

Essential

Knowledge / Skills & Experience

Bachelor’s or associate degree or Diploma / Certificate in Pharmaceutical Science
3/5 years’ experience
Previous experience in a GMP regulated environment
Proven track record of showing how results were delivered through
management/leadership of others.
Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.

Desirable

Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.

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, 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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Responsibilities