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Accountable for process validation planning and execution including supplier process validations, e.g. Master Validation Planning (MVP/MVR), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Product Performance Qualification (PPQ) and Supplier Process...

Act as the quality lead and single point of contact for quality in assigned global product development and change projects, ensuring close alignment with Project Managers, Innovation, Engineering, Supply Chain, Production, Procurement, Product Management, and quality functions....

• Monitor and evaluate global, regional, and local regulatory developments relevant to the business area
• Assess regulatory risks and opportunities and communicate business impacts to stakeholders
• Develop and implement regulatory strategies that support business objectives and market expansion

• Maintain and continuously improve the Quality Management System and approvals.
• Act as the primary interface with civil and military aviation authorities, customers and certification bodies.
• Plan, lead and support internal, customer, supplier and regulatory audits.

• Preparation and visualization of quality- and process-related metrics, as well as data validation in databases (e.g., using Power BI)
• Support in the creation, revision, and updating of process and quality documents
• Coordination and tracking of review and approval processes

• Support the review and approval of quality changes to the management system
• Help implement departmental objectives and maintain quality requirements and compliance within the management system, working with relevant functions and business areas
• Act as a key user for SAP, DMS, APM and TrackWise

Shape quality from the start: Translate strategic ambitions into clear, actionable QA deliverables for corporate and new business development initiatives...

• Lead external sterilisation activities for active ingredients, excipients, and packaging materials.
• Prepare, review, and maintain sterilisation validation documentation.
• Support SIP and bulk product validation activities.
• Manage filter validation programs and ensure regulatory compliance.

Manage key operational quality processes, including non-conformance reports (NCRs), quarantine, quality holds, field actions, line clearance and escalation to manufacturers....

• Coordinate quality assurance activities in design and development projects
• Provide quality guidance on project and product compliance, design controls and design changes in collaboration with Development, Software, Risk Management, Regulatory Affairs and Product Care

Lead analytical activities including optimization, transfer, validation, and troubleshooting, ensuring methods are scientifically sound and fit-for-purpose...