Medis Commercial Quality (CQ) Head

We Are Teva

Medis was established in 1985 and is a leading third-party out-licensing company offering over 200 high-quality generic pharmaceuticals to third-party pharmaceutical companies worldwide. Medis builds long-term customer relationships through proactive communication and optimized customer experience. Medis is fully backed by Teva Pharmaceutical Industries Ltd. and leverages its development and manufacturing capabilities, with a strong focus on confidentiality, technical excellence, and compliance.

The Opportunity

In this role, you act as responsible Commercial Quality Head of Medis (Teva). You perform this role in alignment with business unit, in order to ensure products are efficiently distributed to customers by meeting Teva, regional and local standards and customer needs. You are also managing the Commercial Quality unit team (2 people) and are the Commercial Quality business partner of the Medis VP or its delegate

How You’ll Spend Your Day

In this role you will need to be result-driven and demonstrate initiative that creates an appropriate level of urgency to meet objectives and deadlines. You will determine stakeholder´s needs and expectations and adhere to the determined timelines. You will gather and assess relevant information, using abstract ideas to interpret it effectively, and understand when problems need to be escalated.

Following are among other going to be also your tasks

• Managing and leading Medis Commercial Quality team members
• Establishing network for the business unit with direct and indirect reports
• Leading periodic Local Quality Management meetings with commercial unit Management and other supportive functions
• Ensuring the execution of sub-regional projects coordinated in the business unit
• Ensure GMP and GDP compliance at the commercial unit and promote quality culture,
• Creating and maintaining up-to-date and distribute Standard Operating Procedures and Working Instructions as per Teva standard and in compliance with national regulations,
• Ensuring initial and continuous GMP and GDP training implementation and maintenance at a local level,
• Decision-making on country level, based on national legislation and aligned with Teva QMS
• Ensuring GMP/GDP compliance of Medis Customers and Vendors, handling complaints and recalls, change control, deviations and CAPAs
• Ensuring also permanent Authority inspection readiness in the commercial unit and compliance with local regulatory requirements as well as host local Authority inspection
• Communicating with clients, vendors, authorities, third parties etc.
• Escalating critical quality issues raised at local level
• Your Skills and Experience
  • You have at least Master´s Degree in Pharmacy, Medicines, Biology or an equivalent combination of education and experience to the functional role. We strongly preffer Post-graduate or Doctoral degree in Pharmacy, Medicines, Biology or similarly related fields of specialization
  • Minimum of 5 year experience as a Quality Manager/QP/RP in a pharmaceutical company or importer/distributor
  • Demonstrated knowledge and working experience with Icelandic government regulations
  • In-depth knowledge of pharmaceutical industry as it relates to Quality Compliance
  • Working knowledge of pharmaceutical operations
  • In-depth understanding of GxP's regulations
  • Experience with development and implementation of Quality Systems and application of risk assessment tools
  • Proficient computer skills in current software including AI tools, MS Office etc…
  • Excellent English and fluent in Icelandic
  • Open minded, out of the box thinking, creative thinking to create the most efficient solutions
  • Stress resistance and ability to learn quickly and independently
  • Team player, stakeholder manager and great communicator