Quality Assurance Specialist for CSV

The Position

This position is responsible to ensure that the assigned global, local, cross-business and cross-functional computerized systems meet the requirements of Boehringer Ingelheim internal regulations as well as the requirements regarding computerized systems validation/qualification of applicable global regulatory agencies.
The role has to approve that such systems are implemented according to current regulatory requirements and maintained in such a manner to ensure an ongoing state of quality and control.

Contribute to design appropriate local, regional and global organizational structures and processes with broader impact supporting the IT application and template landscape.

Gives active advice on setting up optimal validation/qualification strategies and ensures that all process and technical topics are fully considered
Responsible for quality oversight of the entire application system elements in scope, during its implementation and operational phase, including KPIs and trend analysis. Recognition and derivation of necessary control measures including necessary escalations.
 

Duties and Responsibilities:

• Global Quality responsibility for ensuring computerized systems used within area of responsibility are implemented and maintained in such a way to meet all global regulatory requirements, including computerized systems validation/qualification, GxP regulations (regarding processes which are supported by the computer system), electronic records and signature requirements. 
• Ensure the right level of Risk taking within the Risk Based Approach depending on process and technical risks
• Proactive and consultative engagement of the Computer System Validation role within agile projects
• Guide business stakeholders and cross-functional project teams through the LeVa framework by conducting self-developed, process adapted training. 
• Give active feedback into the CSV MSO Network on topics where the LeVa Framework can be optimized, especially on validation/qualification issues for new technologies.
• Provide expert input to stakeholders reducing noncompliance risks with negative impact on the business.
• Ensure that providers of computerized system solutions, be it software or cloud solutions, can provide products or services that meet Boehringer Ingelheim's internal requirements as well as all regulatory expectations. 
• Conduct assessments of potential suppliers and providers and consult with business stakeholders as to the quality levels and fitness for use observed
• Preparation, coordination and presentation of the area of responsibility in audits and authority inspections.
• Perform self inspections to ensure compliance with internal and external regulations.
• Ensure continuous improvement of the corporate strategy, processes and procedures related to computerized system validation/qualification.
• Reviews and approves relevant SOPs.
• Active participation  and consulting during projects incl. independent coordination and  execution of complex work packages related to implementation and/or activities pertaining to operational phase of a computerized system in the area of computerized system validation/qualification and compliance.
  • Example for complex work packages:
    •  Setup Validation/Qualification Strategy 
    • Migration planning / execution
    • Transition planning / execution
    • Validation/qualification summary and handover to operational phase
• Provides guidance to the external resources supporting the CSV team by successfully onboarding them on work packages, defined ways of working, and efficiently tracking the completion of tasks in both timeline and quality. 
• Foster a common quality culture and understanding within the team and the corresponding business partners.
• Comply with the relevant (BI internal) safety guidelines and specifications in the working environment. Strive and support zero accidents.
• Perform safety measures according to internal requirements.
   

Requirements:

• Diploma degree and/or Masters degree (e.g. MBA, MSc) and/or Bachelors degree with major focus on Pharmaceutics and/or IS/IT and/or Engineering
• Excellent knowledge of international GMP requirements, Quality systems, Quality management (as applicable: EU-GMP Guideline, 21 CFR 210/211, 21 CFR Part 11, Annex 11, ICH Q9, Q10, applicable GAMP, ICH E6 - GCP,relevant EMA & FDA Guidance and ISPE guides, etc.) and BI's LeVa Framework.
• Well-founded knowledge in MS-Office
• Profound experience in a GxP regulated environment (with minimum of 3 years) with focus on quality assuranceand/or computer system validation/qualification.
• Strong written and oral communication skills, ability to influence and manage upward, ability to work well inteam environments.
• Expertise in Project Management
• Ability to prioritize and to effectively manage multiple tasks at the same time
• Respect and understanding of cultural diversities across the area of responsibility
• Collaborative and integrated working style
• Language skills : English fluency and German is a plus
• Leadership experience: minimum of 3 years leading projects.
• International experience: international exposure in daily business (> 50% of international business/customers/staff)