Teva Director Biosimilar Pipeline Governance 

United States, New Jersey 

540916434

The Senior Manager Commercial Quality/RP is a position located in our commercial affiliate in Denmark. The position is reporting directly to the Site General Manager and has a Quality reporting line to the Associate Director Commercial Quality FI and North & West Europe Hub

• Manage and lead the Commercial Quality Team in Denmark.
• Act as Responsible Person in accordance with EU Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01) and applicable regulations on medical devices / food supplements.
• Establish network in the country with direct reports and relevant stakeholders
• Lead periodic Local Quality Management meetings with commercial unit Management and other supportive functions (Supply chain, Regulatory Affairs, Pharmacovigilance…)
• Have regular meetings with the local General Manager of the commercial unit and Associate Director Commercial Quality N&W Hub to align quality objectives with business objectives and local strategic plans
• Participate in the annual budget elaboration
• Lead periodic face to face meeting with CQ team members and lead periodic local CQ meetings
• Support Teva and Quality strategic business initiatives
• Support Quality initiatives outside the country and collaborate with international colleagues as needed
• Ensure GDP compliance at the commercial unit and promote quality culture
• Build relationship and act as contact person for local authorities
• Lead inspection readiness programs
• Lead Local cross functional Quality Management Review or delegate appropriately
• Attend to N&W Hub and European monthly Quality Councils
• Provide the local monthly quality metrics to the European Commercial Quality
• Provide GxP guidance and quality oversight of local GxP business activities/deliverables
• Define a delegate as back up and keep appropriate records of any delegated duties

You are an enthusiastic professional with a Master in Pharmacy or an equivalent combination of education and experience to the functional role. On top of this you will bring a few years of experience as a Quality Manager, QP or RP in a pharmaceutical company or importer/distributor.

• Demonstrated knowledge and working experience with government regulations and local authorities in Denmark
• In-depth knowledge of pharmaceutical industry as it relates to Quality Compliance
• Working knowledge of pharmaceutical operations
• In-depth understanding of GxP regulations
• Experience with development and implementation of Quality Systems and application of risk assessment tools
• Proficient computer skills in current software including MS Office
• Demonstrates initiative and creates an appropriate level of urgency to meet objectives and deadlines.
• Proven ability to work within a team and influence people outside areas of authority to achieve results.
• Demonstrates good communication (oral and written) skills.
• Excellent proficiency in English and Danish

• Vacation leave according to The Danish Holiday Act
• 5 extra holiday entitlements
• Competitive salary
• Bonus based on personal and company result
• Collective health insurance
• Flexible working conditions with hybrid working policy
• Competitive Pension
• A very diverse International team

Ivo Huijskens - Senior Recruiter Europe

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