Quality Operations Manager FT

PCI Quality Manager

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

A key member of the Quality Leadership Team that influences the wider organisation by demonstrating leadership through actions, accountability coaching and development of the Quality Operations, and function departments Quality work closely with. This role requires a self-starter who likes working with the freedom to manage their own area and take responsibility. This is a key succession planning opportunity within the QA organisation.

Technical

The role of the Quality Manager is to lead the QA Operations Team. Define/improve the process with Quality Operations. Responsibility for implementation and execution tasks relating to Batch File life cycle, Process, Facility, Cleaning/Housekeeping from a Quality perspective at PCI Ireland Pharma Services. Customer point of contact, working to ensure OTIF of batch records and Customer commitments.

Main Responsibilities

• Manage the generation and review of all batch manufacturing records within the business unit as part of production start-up and post batch review 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 Operational requirements are understood and ultimately adhered to.
• Ensuring all Quality Operations activities on site relating to Facility, Laboratory Equipment, CSV, Processes (packaging and cleaning), and Data Integrity meet the expectations of clients but more specifically meet regulatory requirements (HPRA/ FDA).
• Define Quality Operations KPI's, and batch schedule. 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 products packed in the business unit and respond to customer queries related to product investigations.
• Manage the Quality Operations team. Train, develop, coach the team on the incoming goods, bath file review, Events, Deviation, Non Conformance systems, documenting, and execution. Manage HR related activities. Complete Quantum 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 must utilise 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.

Join us and be part of building the bridge between life changing therapies and patients.

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.