Quality Assurance Professional (m/w/d) Germany

Arbeitsort: Neu-Isenburg 63263, Hessen, Deutschland, hybrides Arbeitsmodell
Vertragsart: Dauerhaft
Stelle ID: 3802

The role:

The Quality Professional ensures that the distribution of LEO Pharma products is done according to regulations.

The Quality Professional ensures that LEO Pharma Germany is compliant with local legislation and LEO Pharma Global procedures. They support LEO Pharma Germany and the Global Quality organization with oversight audits, inspections, supply set up – both in Germany. Furthermore, they support global activities such as projects, audits, and quality oversight

This function maintains quality compliance with Good Distribution Practice (GDP) and LEO Pharma Standard Operating Procedures (SOPs). The Quality function also ensures the timely release of incoming product batches into the marketplace for sale; assisting LEO Pharma in meeting financial sales targets and ensuring that quality product is available to patients.

Your responsibilities:

• Quality oversight of affiliate, local market release, PoC to Health
  authority
• Act as primary Quality contact person with Third Party Logistics (3PLs), wholesalers, distributors/third parties in the markets for quality related requests
• Maintain local license (WDA)
• Keep abreast of local regulations, pharmacopoeia, best practices, and maintain inspection readiness
• Develop and maintain appropriate local Quality Management System to ensure that operations are in compliance, efficient and are continuously improved
• Act as Responsible Person for LEO Pharma Germany
• Local batch release management: Timely approval of incoming batches, batch inspection and perform release according to LEO Pharma SOPs
• Support free medical sample distribution
• Stop the distribution of products if a serious/critical deviation happens
• Implement recall procedures if necessary and perform mock recall to ensure recall procedures are adequate
• Advise Principal QP promptly if counterfeit/tampered product is detected in the market
• Manage returns: approve any returns to saleable stock
• Decide on the final disposition of returned, rejected, recalled or falsified products in cooperation with the Principal QP
• Maintain quality agreements with manufacturers, 3PLs, wholesalers and distributors, when applicable
• Sign quality agreements as MAH with LEO Pharma manufacturing sites
• Deliver local quality intelligence to global function related to GMP/GDP requirements and new legislation in the market
• Monitor quality aspects of warehousing and shipping practices for compliance with GDP
• Manage and evaluate (trend) product complaints, deviations, Corrective Actions and Preventative Actions (CAPAs)
• Review and approve Product Quality Reviews
• Lead/collaborate with Germany organization on change controls
• Update/maintain local Quality SOPs and local training matrix
• Monitor global SOP updates and assess local impact, including preparation and development of local SOPs
• Monitor GxP KPIs in LEO Pharma Germany.
• Lead the GxP Quality Management Review and follow up on actions from the meeting
• Support inspections/audits of distributors and wholesalers as necessary as per GDP/GMP requirements
• Take part in Global Quality improvement projects
• Deliver on area goals and strategy
• Act as an ambassador for Global Quality
• Obtain and maintain new competencies and knowledge within relevant quality disciplines and industry trends
• Deliver quality training and quality support to LEO Pharma Germany organisation
• Liaise with customers/stakeholders and regulatory authorities regarding quality matters, including hosting inspections/audits and responding to observations
• Perform Out of Stock notifications to competent authorities

Your qualifications:

• Degree in Life Sciences, B.Sc. in Pharmacy or equivalent experience
• Fluent English, written and spoken
• 5+ years relevant experience in the regulated pharmaceutical industry, specifically including Quality Assurance/Quality Control and/or Regulatory Affairs
• Experience with local health authority inspections and/or third-party audits
• Solid decision-making skills and computer skills
• Customer focused - building strong customer relationships & delivering customer-centric solutions
• Drives results - consistently achieving results even under tough circumstances.
• Collaborates - building partnerships & working collaboratively with others to meet shared objectives
• Drives Engagement - creating a climate where people are motivated to do their best to help the organization achieve its objectives
• Optimizes Work Processes - knowing the most effective and efficient processes to get things done with a focus on continuous improvement
• Good collaboration and communication skills
• Ability and willingness to travel domestically and internationally as required

Nehmen wir gemeinsam eine Vorreiterrolle ein

Wir bei LEO Pharma helfen Menschen mit Hautkrankheiten, ein erfülltes Leben zu führen, indem wir die Dermatologie über die Haut hinaus weiterentwickeln. Wir fördern die Dermatologie mit unserem Wissen, unserer Zusammenarbeit und unserer Neugier, und wir bilden die Speerspitze der Wissenschaft bei der Entwicklung neuer Medikamente. Bei der gemeinsamen Pionierarbeit geht es uns darum, die Möglichkeiten für einander, unser Unternehmen und unsere Patienten ständig zu verbessern und zu erweitern.

Wir bei LEO Pharma glauben, dass unsere unterschiedlichen Perspektiven, Hintergründe und Einstellungen uns in die Lage versetzen, die besten Entscheidungen zu treffen, eine inklusive Kultur zu fördern und die Bedürfnisse des Marktes zu erfüllen, in dem wir tätig sind. Daher möchten wir Sie ermutigen, sich für die Stelle zu bewerben, wenn Sie sich für die Aufgabe begeistern können - auch wenn Sie nicht jede einzelne der aufgeführten Anforderungen erfüllen, könnten Sie genau der Pionier sein, den wir suchen. Wir glauben an Flexibilität in allen Aspekten - auch wenn es darum geht, die unterschiedlichen Bedürfnisse unserer Mitarbeiter zu unterstützen, daher bieten wir, wann immer möglich, Möglichkeiten für gemischte Arbeitsverhältnisse.

Für bestimmte Positionen könnte LEO Pharma eine Hintergrundprüfung abschließen, die von einem Dritten durchgeführt wird.