דרושים ב-Teva ב-Turkey, Istanbul

• Market release operations for batches both imported and local to local products (from local CMOs)
• Ensure GDP compliance support while working at the 3rd party distribution center (sales warehouse)
• Accountable for technology transfer projects by having analytical transfers and process validations (including design of the studies, review/approve protocol and reports, attend production of validation batches as an observer etc.) executed at CMOs in timely manner.
• Support KPI reporting & evaluation and discussion at global level in Quality Councils
• Accountable for successful QMS (preferred Trackwise, Veeva) forpost-marketin quality issues such as customer complaints, returns etc.
• Identify Quality / Compliance risks at CMOs, resolve issues and minimize risks and input, review and endorse investigations in the local manufacturers
• Drive continuous improvement /CAPA processes at the CMOs through target setting, quality expert meetings, regular Business Review Meetings
• To have active role in the process/quality improvement/ technical troubleshooting projects to drive risk reduction activities to ensure product robustness, sustainability and capability at CMO.
• Maintain product risk oversight by reviewing PQR, stability data, BMR, validation report etc. and proactively drive risk reduction program
• Provide to maintain the robust quality assurance system with the company SOP & Training management
• Provide maintenance of company QMS to ensure compliance to local and global regulations
• Manage/follow up new & cuurent regulatory compliance necessities & ensure changes and improvements in the QMS accordingly
• Support global QMS projects on behalf of Teva Affiliate
• Support Vendor Qualification and Maintenance

• Bachelor’s degree in pharmacy/chemical engineering/chemist or equivalent scientific degree
• In pharmaceutical industry, minimum 7 years of experience in a similar position in local manufacturing related business models or manufacturing environment itself.
• Background in R&D or/and Quality Control Laboratory is strongly preferred in parallel with Quality Assurance. Proven experience working with technical and operational teams troubleshooting.
• Experience in production & method validation processes, quality oversights in different culture local manufacturers, technology transfer projects, knowledge about the technology of different types of finished product and raw material characteristics such as sterile, non-sterile, non-beta lactams and beta-lactam-penicillin, biotech etc.
• Excellent planning, co-ordination, communication skills
• Ability to manage multiple tasks and strong daily follow up skills.
• Energetic and committed to continuous improvement, meeting evolving Quality compliance expectations.
• Result-oriented, analytic, and well-disciplined.
• Advanced level of English, good knowledge of MS Office applications and being experienced with computerized Quality Systems is preferred.
• Ability to work as part of a team within an international and multicultural team at various level of organizational leadership.
• Knowledge of local current and upcoming legislation and current Quality Standards and advanced knowledge of cGMP requirements
• Advanced understanding and insight into the different aspects of quality functions like QC, QA, Quality Systems, Compliance, Documentation etc.
• Advanced negotiation, interpersonal and presentation skills
• Change Management Experience within the complex MoH, Vendor, CMO environment
• Able to travel to local contracted manufacturers

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Supporting the CLCM strategy of Teva TR by;

• “Portfolio Management” (pipeline development & launch excellence)
• Forming strategic partnership for existing and/or new TA’s, developing possible business opportunities for tail products (in licensing / out licensing) with “Business Development

Portfolio:
Pipeline Development

• Manage, understand and execute the Teva TR pipeline strategy.
• Create accurate processes and lead pipeline selection process to build a strong portfolio and to achieve sustainable growth in the market.
• Prepare robust business cases, forecasts, and resource allocation for pipeline development; update timelines, required investments and provide regional input for selected products.
• Partner with IM Regional Portfolio Team regarding pipeline specific needs & demands. Actively participate in regional processes and activities with accountability.
• Partner with local cross functional teams (Finance, RA&MA, Commercial, Medical, Supply etc.) and support, communicate, coordinate all pipeline strategy activities with related stakeholders.

Launch Excellence:

• Manage all launch strategy and excellence process steps.
• Provide back-end perspective, develop forecasts and lead on time launch of launch pool products taking into account marketing, medical and technical aspects.
• Understand and communicate requirements for registration, reimbursement, and differentiation needed for successful commercialization in Turkey.
• Ensure on-time submission and launch with expected value via prioritization, escalation, root cause identification and decision-making platform.
• Partner with local & IM cross functional teams (Finance, RA & MA, Commercial, Medical, Supply etc.) and support, communicate, coordinate all launch products and activities with related stakeholders.

Business Development:

• Lead and support SP & BEX department on developing the company short/mid/long term growth strategy for a sustainable business.
• Lead, coordinate and execute the Teva TR BD projects and processes.
• Evaluate industry trends, build business development understanding, identify high potential business models, understand existing or new BD requirements and asses their impact on company results.
• Prepare robust business cases, forecast and resource allocation for BD projects: update timelines and resource allocation for BD projects; update timelines, required investments; develop agreements for a wide variety of BD project and provide structured input for decision makers.
• Follow IM & Global BD guidelines & compliance practices. Actively participate in regional process and activities with accountability.
• Partner with local cross functional teams (Finance, RA&MA, Commercial, Medical, Supply, Legal, Compliance etc.) and lead, communicate, coordinate all BD projects and activities with related stakeholders.

• A thorough understanding of portfolio management, pipeline development, developing new business models & BC’s, registration, reimbursement, agreement processes, marketing, market dynamics, financial metrics.
• Bachelor’s Degree preferably in engineering or social science / MBA is an asset
• 5-7 years work experience in the similar position. Pharma experience is preferred.
• Fluency in English, MS Office applications
• Ability to coordinate projects w/in multiple cross functional teams.
• Strong analytical and critical thinking skills
• Having clear understanding on sectoral developments and relevant regulations
• Strong customer focus and ability to interact effectively and successfully across the internal/ external stakeholders.
• Demonstrates time and project management skills.
• Ability to plan and prioritize workload and evolve based on changing demands and environments.
• Self-motivated, engaged, passionate, committed, agile and flexible.
• Able to travel locally and internationally when necessary

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.