DPS Group Global
Description:
Act as the Associate Operational leader for some virtual European sites within the Speciality Care External Supply network. Ensure serialization and Artwork management with our CMO, in accordance with internal systems and policies.
Your Key Accountabilities
• Ensure implementation of serialization (via Tracelink) and management of Artwork (Vistalink) with CMO working for our client
• Ensuring product supply to our client through external contract manufacturing organizations (CMO) or partnerships
• Lead internal and joint cross-functional Core Teams (CT) and associated +QDCI sessions
• Provide operational lead support to principle Operations lead(s) in case of more complex product-CMO settings, typically within the Autonomous Production Unit (APT) you reside within.
• Prepare and Perform in collaboration with CMOs in scope regular Quality Business Reviews in accordance to established agreement and performance criteria.
• Continuously strive/drive improvements in performance of the supplier in all relevant areas of Safety, Quality, Cost and Delivery
• Ensure execution and reporting on CMO performance according to Key Performance Indicators (KPI) and relevant criteria to Principle Operations lead and/or APT lead
• Oversee SCES consolidated (CT /product) budget/spending view
• Ensure actual spend with CMO is in line with relevant budgets. Motivate deviations and capture as part of forecasting process
• Actively support the identification of product life cycle management and process improvement initiatives at CMOs; support formulation/presentation of corresponding business cases and approval by management.
• Assume a key project team role, representing SCES
• Be SCES representative in Industrial Product Team
• Establish and maintain a positive/constructive culture of collaboration and partnership with CMOs or Partners.
• Works under general supervision of a principal CT or APT lead to whom you typically also report
Your Qualifications
Education
– Bachelor or Master’s degree in pharmaceutical/biomedical science or packaging engineering
Experience
– At least 2 years of experience in secondary packaging of pharmaceutical drug products
– Artwork management experience
– Serialisation experience
– Working in a cGMP environment
– Leading cross-functional teams in an international environment
– Good understanding of GMP requirements and regulations
Nice to have:
• Experience in managing supplier relationships in the Pharmaceutical industry
• Some experience in contract negotiations
• Solid business acumen and negotiation skills
• Knowledgeable of project management techniques and tools
• Ability to lead continuous improvement of technical processes and to execute production and project schedules
• Experience in troubleshooting, investigation, root cause and risk analysis in a cGMP environment
• Track record in leading problem solving and process improvement teams
Language skills
• Being fluent in English is a requirement, Flemish is an advantage
Behavioural and LEAD-competencies
• Act for Change and continuous improvement oriented. Challenge status quo and drive innovation
• Strive for results and taking personal responsibility for achieving them
• Cooperate Transversally and create effective cross-functional working relationships
• Effective communication,
• Excellent interpersonal skills and experience operating within a matrix
• Play to win mind set
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