Primary Job Function:
- Lead the cultural change at the Russian site and commitment for achieving compliance at the affiliate and completion of the project “Russia Affiliate Site –Q01.07 Improvement Plan”
- Ensure awareness and compliance of new and revised quality documents and regulations that affect the assigned area of responsibility.
- Supports the business in the region according to the position expertise and functions
Core Job Responsibilities:
Ensure Quality System awareness and compliance in the Region:
- Plan and conduct internal audits / assessments to verify the effectiveness of the management system
- Perform supplier/ distributors audits as required. Prepare/ coordinate Abbott corporate/ division and external audits.
- CAPA management follow up and ensure closure.
- Ensure QS record keeping, Warehousing, Quality Holds, Supplier / Distributors evaluation/ monitoring.
- Coordinate Field Communications at the Region.
- Ensure availability of org charts (including LSME) and job descriptions.
- Receive audit input and follow QS Document Control
- Support/provide training to the organization about the ADD Quality System.
- Set and track the Training Plan for all positions. Maintain continuous vigilance upon the employee compliance with trainings, to contribute prevent late trainings.
- Be the expert on a QS process and support the rest of team as process SME.
- 1 direct report - Specialist Quality Russia & CIS
- Higher Education; Bachelor’s degree, Master’s degree or MBA preferred. Higher education with scientific background (i.e. Lab Technician, Biology, Chemistry, Pharma, M.D.) is required.
- At least 5 years of experience in the diagnostic industry (preferred), medical device or related health industry (commercial affiliate or manufacturing) or clinical laboratory. Similar experience as healthcare industry Quality Systems certification consultant is also valued.
- Quality Systems management and auditing experience. Certified auditor.
- Management skills and leadership competencies
- English upper-intermediate.
- Product and market environment knowledge preferred.
- Experience to work in international environment/ projects. Cultural sensibility.