Third Party Operations Quality System Manager

　　Date: Jan 22, 2024

　　Location:

　　Istanbul, Turkey, 34055

　　Company: Teva Pharmaceuticals

　　Job Id: 53326

　　Who we are

　　Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

　　The opportunity

　　Third Party Operations Quality System Manager will support business units by managing quality problems in local manufacturers in a way that does not disrupt local production plans and supply, and will manage technical activities (analytical, process, technology etc.) at CMO site level and Change Management Projects between CMOs, API/excipient Vendors and prepare technical dossiers for MOH submissions.

　　How you’ll spend your day

　　Accountable for technology transfer projects by having the 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 Vendor Qualification and Maintenance

　　Support KPI reporting & evaluation and discussion at global level in Quality Councils

　　Accountable for successful Quality systems management at the interface with CMOs and at the CMOs, covering the overall contract life cycle

　　Engage in Corporate Standarts Processes in related areas

　　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 of PQR, stability data, BRR, validation report etc. and proactively drive risk reduction program

　　Provide support to maintain the robust quality assurance system in the company

　　Provide maintenance of company QMS to ensure compliance to regulations as well as global and local standards

　　Manage/follow up new and current regulatory compliance necessities & ensure changes and improvements in the QMS accordingly

　　Performing internal when necessary and external audits when qualification process is done

　　Support SOP & Training system maintenance

　　Support global QMS projects on behalf of Teva Affiliate

　　Perform release activities with key personnel approval when the Responsible Personal is absent.

　　Your experience and qualifications

　　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 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 local contracted manufactures

　　Already Working @TEVA?

　　If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)

　　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.

　　Teva’s Equal Employment Opportunity Commitment

　　Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

　　EOE including disability/veteran