Senior Manager Commercial Quality - Head Center of Excellence Europe Region

Senior Manager Commercial Quality - Head Center of Excellence Europe Region

Teva

Sofia, Bulgaria

The opportunity

The manager of the local to local (L2L) Center of Excellence (CoE) is responsible to support and ensure Quality Compliance for Commercial Quality in the markets locally, securing local quality activities, qualification and continuous improvement.

The scope of the Center of Excellence (CoE) is the local to local (L2L) compliance of the markets in Europe Region.

This role will require management of a Compliance Quality team (4 persons) through collaboration with the local Quality teams in the countries in Europe Region.

How you’ll spend your day

• The L2L CoE Manager is the Quality partner of Commercial Quality Europe Region and is the coordinator of the local quality compliance of the markets in Europe
• The manager fosters excellence in management of local quality items, amongst others like processing market compliance maintenance, market compliance monitoring, handling quality processes like change control, vendor & supplier list qualification
• Connects in deviation, CAPA, PQR processing to support the compliance of the markets
• Provides guidance to the L2L CoE Quality team, manages its employees to ensure compliance with Teva's global & regional standards, regulatory guidelines plus expectations and cGMP/GDP requirements
• Ensures support for key performance metrics and market quality management review
• Engages with Quality leadership in the review and evaluation of performance data and work with the markets to develop and implement an improvement plan with milestones and timeframes, where transformation is needed
• Interprets internal or external business issues and recommends solutions/best practices
• Ensures local operational implementation of Quality Management System in compliance with GMP&GDP and Teva Corporate & regional standards
• Proposes continuous improvement of processes based the QMS of CQ Europe Region
• Ensures inspection readiness, continuously identify opportunistic areas for improvement
• Promotes a Quality Culture within Commercial Quality

Leadership and Management

• Manages L2L CoE team of quality analysts (4 persons) that provides Quality and Compliance support to the countries
• Builds and maintains a high performance team, identify and develop talents
• Performs annual processes such as budgeting, performance reviews, mid-year reviews, year-end reviews, performance management, etc.
• Provides leadership, mentoring and professional guidance.
• Defines annual objectives for the Region in alignment with Commercial Quality, business priorities and growth strategies.
• Engages, aligns, supports and ensures Quality compliance issues to support the markets in Europe Region
• Works collaboratively with the quality teams in the market to perform activities on improvement there where needed
• Supports the design of what “success” looks like and implement readiness tools and preparedness

Your experience and qualifications

• Bachelor's Degree – chemistry, microbiology, pharmacy, engineering, or related science-based degree - advantage at large and complex sites
• Experience: required 5 years, preferred 5-10 years in a Quality leader in the pharmaceutical field in a management or quality functional leadership position
• Demonstrated knowledge and working experience with government regulations for the cluster
• In-depth knowledge of pharmaceutical industry as it relates to Quality Compliance
• Working knowledge of pharmaceutical operations
• In-depth understanding of GMP & GDP & new authority regulations
• Experience with development and implementation of Quality Systems and application of risk assessment tools
• Proficient computer skills in current software including MS Office
• Excellent English
• Continuous professional development

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