Teva Sr Director Global Quality Compliance 

United States, New Jersey 

92446878

• Accountable for developing the compliance strategy, short- and long-range plans for the Global Computerized Systems Governance organization
• Liaise with TGO Global Quality, site, IT and business stakeholders
• Continuously improve the policy, standards, procedures, tools and training related to cGxP CSV ensuring alignment with regulations (Eudralex Annex-11 and 21 CFR Part-11), industry guidance, inspection trends and current Data Integrity guidance
• Fulfill the role of CSV/Data Integrity subject matter expert and ensure current best practices are exercised in support of global GxP computerized systems
• Institute and deliver monitoring program measuring adherence to current CSV practices within the global IT organization
• Provide site and global resources with CSV and DI consultation to supplant skill gaps
• Provide on-site CSV inspection readiness support before and during regulatory inspections
• Deliver training programs for IT, Quality and site-based resources to improve CSV skills, provide education related to inspection trends and generate awareness of the importance of CSV and Data Integrity
• Architect, govern and manage IT infrastructure qualification aligned with current industry regulations, inspection trends, best practices and guidance
• Ensure Data Privacy regulations are incorporated into the Computerized System landscape
• Provide business ownership of IT based GxP computerized system tools such as IT change management, test management, identity management etc.
• Responsible for computerized system quality for the serialization and aggregation programs
• Afford CSV Quality subject matter expertise and consultative services to the various Teva business segments such as Commercial, TGO, R&D, Clinical and Teva API etc.

Qualifications

• Bachelor’s degree in computer science, science or related field (advanced degree a plus)
• Minimum 15 years of experience and strong overall understanding of Computerized System Validation and quality business processes supporting global functions, manufacturing and laboratory operations
• Prior experience managing direct and matrix teams/projects is required.
• Demonstrated leader in CSV governance
• Strong understanding of regulations and industry standards such as 21 CFR Part-11, Eudralex Annex-11, GAMP 5, Data Integrity regulatory and industry Guidance and proven ability to pragmatically apply these regulations to operate in an efficient and effective fashion.
• Must have international experience

Practical Knowledge and Experience

• Pharmaceutical Quality Manufacturing: Solids, Medical Device, Sterile, Biologics, and/or Biosimilars Quality Compliance experience required.
• Demonstrates continuous professional development.
• Advanced leadership skills, business strategy, accounatbility, proven experience leading leading and motivating global, cross-functional teams.
• Advanced knowledge of local current and upcoming legislation and current IT Quality Compliance best practices.
• Advanced experience in working with matrix environment.
• Advanced negotiation skills.
• Advanced knowledge and experience in Problem Solving
• Advanced ability to understand, interpret, and execute in accordance the Teva Quality Management System.
• Advanced communication skills – written and verbal
• Advanced organization and political agility leadership and teamwork skills
• Project management certification (e.g. PMP) is a plus.
• Must be able to travel based on business need; up to 50% when critically required (domestic and international).

Professional competencies :

• Energetic, committed to continuous improvement. Effective negotiation skills, strong interpersonal skills, excellent presentation skills. Strong project and change management. Proactive orientation, self-motivated, flexible, and innovative way of thinking*.
• Ability to work with various organizational leadership levels and in a team environment across multiple roles. Multi and Intercultural sensibility*
• Languages: English Proficiency*. Proficiency in the local language

• Building Customer Focus
  • Addresses multiple site issues in a timely manner.
  • Effectively adjusts plans to meet changing needs of priorities.
• Applying a Strategic Approach
  • Makes the right short-term decisions without sacrificing long-term results.
  • Integrates input from different areas together and balances all competing demands based on wide and long-term understanding on the business needs.
• Applying Business Acumen
  • Holds a broad perspective and understanding of processes and translates this understanding into Quality terms (and vice versa). Translates business & industry trends and regulatory standards into business imperatives.
  • Applies knowledge of industry's best practices to provide inputs for increasing operational productivity within assigned area of work.
    

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