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QC Team Lead

2 weeks ago

Dundalk, Ireland PE Global Full time

Title: QC Equipment and Systems Team Lead

Location: Dundalk

Industry: Biologics

Description:

As QC Equipment and Systems Team Lead, you will be responsible for leading and managing all project and sustaining delivery functions in the QC Analytical workstream for equipment and systems and will provide vision, leadership and direction for the QC Equipment and Systems team.

Department Description

As QC Equipment and Systems Team Lead, you’ll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you’ll be reporting to the Associate Director for QC Operations.

Responsibilities

Creates a diverse and inclusive culture that excels in safety, quality and delivers on the strategic vision for the QC Department. Supports the QC Laboratory through QC Systems and equipment installation, qualification, operation, and retirement. Leads continuous improvement of QC operations, through their QC Systems knowledge and areas of expertise. Purchase, install, qualify, build, maintain, and integrate QC Systems, as required, including divisional systems, instrumentation, and their software or equipment, in compliance with up-to-date data integrity, regulatory, and industry standards. Author, review and approve technical documents, standard operating procedures, deviations, investigations, change management related to QC Equipment and Systems. Lead project management to meet established QC Systems delivery timelines. Work cross-functionally with our company’s sites and stakeholders to successfully implement Technology Enabled Labs capability within the QC department. Define and lead the change management process and mechanisms required to maintain QC Equipment and Systems in a validated state throughout their lifecycle. Troubleshoot equipment, systems, instrumentation, and their associated software as subject matter expert (SME). Lead, coach and mentor the QC Equipment team. Build diverse talent with the capabilities necessary to succeed in commercial drug substance manufacture. Develop team members through supporting their continued personal and professional career growth. Assisting in and facilitating investigations (leading where required), ensuring effective Root Cause Analysis and CAPAs. Represent the QC department as a QC Systems SME for internal audits/regulatory inspections and support permanent inspection readiness. Escalate potential cGMP or compliance issues effectively in a timely manner for appropriate resolution to ensure product quality. Drive and own metrics that appropriately and accurately measure QC performance and take action to mitigate as required. Manage and facilitate Equipment tier meetings and support various site functional and cross functional tier structures. Actively participate in Site/Quality committees and works with other site functional groups to help set direction for GMP and continuous improvement initiatives. Be customer facing and support client meetings, scoping project plans and customer needs. Responsible for managing risks, completing impact assessments, and developing mitigation strategies and escalation as necessary. Collaboration with departments across the business including Manufacturing, QA, Supply Chain, Procurement, Engineering and EHS to ensure the project needs are met. Manage the release of each instrument/equipment in alignment with NPI (New Product Introduction) and the Production schedule and deliver through the planning process with relevant stakeholders such as CAPEx Project Engineers, PEV, QA, QC System Owners, and Engineering. Report out to SLT and Client when required regarding workstream progress using weekly slides, weekly schedule progress tracker, System Release Tracker. Ensure documentation deliverables are met as per the relevant categorisation of each instrument and associated SOPs. Identifying and monitoring key milestones and addressing issues that may impact the critical path of the schedule. Manage QC Equipment and System schedules as required Equipment PM/PV, periodic reviews, calibrations to ensure there is no impact to the QC Laboratories. Perform all duties in accordance with GMP requirements, SOPs and controlled documents as required. Will be flexible to take on additional tasks and responsibilities at the discretion of the QC management team. Will act as a role model for the QC function and the wider organisation in adherence to the corporate core values.

Education and Experience:

Diploma / degree or higher qualification in Chemistry, Biology, Microbiology, Engineering or in a relevant discipline. 5+ years’ experience working in a fast-paced environment. Experience in a GMP facility, in a lead or project management role is desirable. Experience with facility start-up projects (brown field or green field) is desirable. Experience in the management of complex cross functional projects. Strong computer skills MS Office (WORD, EXCEL, PowerPoint). Strong stakeholder management skills and proven experience dealing with site groups. Excellent communication and interpersonal skills. Strong problem-solving skills and ability to work cross-functionally as critical member of site team. Knowledge / experience in the operation of GMP Pharmaceutical Sites would be an advantage.

Interested candidates should submit an