Компания "TEVA"
PURPOSE OF THE ROLE
- QA Director for Russia & Eurasia is responsible for leading Quality Assurance department, building & maintaining Quality Management system, defining and promoting quality mindset across organization, working cross-functionally to deliver products under required quality standards
WHAT YOU WILL DO
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- Managing QA employees, setting goals, monitoring of execution
- Organization of creation, implementation and maintenance of Quality Management System including GDP requirements as well as requirements of Teva Corporate Policies and Standards
- Ensure GMP & GDP compliance at the commercial unit and promote the quality culture
- Development and monitoring KPIs to measure effectiveness of Quality Management System
- Organization of quality audits of local GMP/GDP-related services providers
- Organization of EAEU GMP audits for foreign manufacturing sites, supporting manufacturing sites for preparations to inspections
- Organization of processes for products release, state/random Quality Control, recalls, handling of deviations & complaints, change control, CAPA management
- Interactions with State Authorities with respect to GMP/GDP compliance, reporting of quality deviations, recalls
- Identification areas of improvements and develop strategies to address the areas
- Collection and analyzing data to identify trends and opportunities for improvement
- Creating and distributing of reports with respect to QA KPIs to local management and Regional/Global QA organization
- Ensure the market release from approved suppliers based on local regulations, batch release documentation and transport conditions documentation
- Ensure the distribution traceability of finished products and returns of products commercialized in the country
- Ensure the GDP compliance of the distribution centers
- Ensure that quality complaints are registered and liaise with manufacturing site to trigger corresponding investigation and adequate corrective actions. Liaise with pharmacovigilance department if necessary
- In case of recall ensure the local coordination between PhV, Medical Affairs, Regulatory Affairs, Supply Chain and with site Quality Head/ EU Qualified person concerned. Escalate any critical information to Regional Head of Commercial Quality and issue the final recall
- Report to Regional Quality and local management any critical quality incident
- Host and lead GMP/GDP related competent authority inspections
- Perform or coordinate internal audits of the compliance of the Quality System
- Perform or coordinate external audits, with respect to quality related matters, of local warehouses/distributors and other local suppliers/service providers as per Teva standards
WE EXPECT
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- 5+ years experience in the similar role
- University degree of Pharmacy/Medicine/Chemistry/ Biotechnology/ Biology
- Experience in managing a cross functional quality team
- Outstanding leadership and partnering competences
- Advanced analytic and structured problem solving competences
- Well developed business management, negotiation and customer relationship building skills
- Strong convincing, communication and customer relationship skills
- Solid knowledge and experience of quality legislation, industry standards and guidelines in Russia, Kazakhstan, other CIS with respect to medicines, food supplements, medical devices, cosmetics
- Self-motivated and independent
- Ability to meet deadlines under pressure
- Critical & systems thinking and risks management skills
- Excellent communication skills (verbal and written)
- Fluent in written and spoken English
- Strong organization/planning skills and ability to manage multiple concurrent projects
- Proven experience in execution: ability to bring strategy to a tactical level and get projects started and completed
- Proven track records of tangible achievements
- Demonstrated ability to lead without authority
- High ethical standards and personal integrity
WE OFFER
Working in a beautiful office in the center of Moscow in a hybrid format:
3 days from the office and 2 days from home
Taking care of you and your loved ones:
- Extended insurance programs (life insurance, health insurance with dentistry for you and one close relative)
- Additional payment for sick leave
- 5 additional paid vacation days per year
- Remote psychological assistance from RESO
- Discounts and special offers from the company's partners
Competitive social package:
- Food subsidy
- Payment for mobile communications
- Laptop
- Corporate car or car allowance
Professional development:
- Corporate training and development programs
- Individual development plan for each employee
- Corporate online library
Engaging corporate life:
- Online communities to support your hobbies and find like-minded people
- Corporate Volunteering program
- Corporate parties and events
- Summer internships for employees' children
- Webinars with internal and invited speakers
And much more!