Clinical Supply Project Manager - Packaging and LabellingThis is a full-time, permanent position working a 35 hour week flexibly Monday - Friday between 07:00 - 19:00.

The scope of work involves managing activities related to the production of clinical trial labels and finished clinical supplies utilizing internal (client) and external contracted resources to meet clinical study design requirements. The following responsibilities and qualifications apply.

Responsibilities

Supports delivery of clinical supplies through effective management of assigned clinical project packaging projects. Liaise with Trial Supply Managers on packaging and labelling design, production scheduling options for on-time delivery, SAP demand entry, SAP material creation and other related purchasing activities.

Manages multiple projects, coordinates deliverables (product, code, label text) with production schedules, develops detailed time and event schedules, and tracks all activities and milestones. Identifies and reports issues to management in a timely manner.

Generates internal packaging and labelling and label print production orders in accordance with the clinical trial design and regulatory requirements. Creates/releases BOMs and process orders in SAP, including checks on order accuracy.

Sources labels from approved label vendors. Supports outsourcing strategy by monitoring vendor compliance with Master Service, Technical and Quality Agreements and completing vendor quality metrics.

Manages assigned labelling requests and outsourced packaging and labelling at approved vendors.

Collaborates with CSO, Analytical and Quality colleagues to ensure on-time testing and release of projects.

Ensures regulatory and GMP compliance of activities, monitors vendor performance, and reports deviations to line management and Quality.

Supports GMP compliance through investigations for deviations and contributes to the CSO Risk Register.

Authors new or reviews existing procedural documents to ensure compliance with GMP and relevant business practices.

Identifies opportunities for process improvements and participates in continuous improvement projects.

Participates in assigned training including CGMP and safety training; may provide staff training as identified.

Ensures sustainable project management and outsourcing operations by developing self and others with technical support across services.

Checks BOMs, change and process orders for other Project Management Coordinators.

Qualifications

BSc degree in Life Sciences, IT or related field or equivalent qualification. Significant relevant experience may be considered in lieu of educational qualifications.

Some experience in clinical supplies project management.

Relevant experience in a GMP-regulated industry.

Strong problem-solving skills and ability to work across cross-functional teams and geographies; able to schedule and prioritise work.

Ability to work accurately to deadlines in a fast-paced, rapidly changing environment.

Excellent written and verbal communication skills.

Strong interpersonal skills and the ability to share knowledge and train others in clinical trial label generation and production.

Working knowledge of MRP systems (e.g., SAP).

Benefits

Reward and Recognition

Health Cash Plan

Life Assurance (4 times annual salary)

Company Pension Plan

Employee Assistance Programme 24/7 confidential support

Free car parking

Worldwide career opportunities

Perkbox access

What Happens NextOur people are the backbone of what we do. You may be invited to meet the team in an assessment centre or staged interview process depending on the role. This will give you the opportunity to see what working for Eurofins is like and to showcase your skills and strengths.

Your dataAs part of any recruitment process, the company collects and processes personal data relating to job applicants. The company is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations.

Equal OpportunityWe embrace diversity. Eurofins is an Equal Opportunity Employer and prohibits discrimination based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and other protected characteristics.

SustainabilitySustainability matters to us. We aim to achieve carbon neutrality by 2025 through emissions reduction and compensation initiatives.

Find out more on our career page.

#J-18808-Ljbffr