Head of Digital Quality

CSL Behring is a global biotherapeutics leader driven by its promise to save lives.

We are currently looking for a

In this newly created role as Director of Digital Quality, you are part of the Quality Systems & Compliance organization within Quality in CSL Behring. As such, you are accountable for ensuring that the computerized Quality Management System (QMS) is established, implemented and effectively maintained. Furthermore, you assure that computerized QMS procedures confirm all applicable regulatory agency guidelines.

In this leadership role, you are accountable for providing the vision of how Quality Management applies for all software & computerized technology across the organization and in all legal business entities. You are responsible for collaborating closely with the Global and Enterprise wide Information & Technology organization (I&T) and the Global Engineering Execution Systems organization as their Quality partner to monitor the overall effectiveness of the Validation and Operational quality activities within these organizations.

In detail, your responsibilities include:

• Quality partner to the Global I&T Organization and Global Engineering Execution Systems organization
• Directing a multi-national team of Digital Quality leaders and their team members  in their role providing quality oversight for all computerized/software technology and the GxP compliant implementation of systems
• Contributing to the strategic roadmap for the global computerized Quality Management System (cQMS) and negotiating and influencing Stakeholder Senior Management to champion initiatives to achieve quality and compliance, cost-effectively
• Directing the maintenance and improvement of the computerized Quality Management System with technology partners to ensure a modern, risk-based, scalable approach to implementation and ongoing operations
• Expert Advisor on matters related to technology QMS, Data Integrity, and other regulatory areas within the computerized systems arena. Conducting gap assessments, and launches initiatives for continuous improvement
• Developing and implementing training programs to maintain cQMS and regulatory awareness and assuring appropriate training is provided to new recruits or consultants during the on-boarding process to ensure consistent use of the CSL QMS
• Managing external GxP software vendor audits and providing support for Internal/External Audits in the computerized/software technology space; Leads appropriate quality oversight for GxP technology audits to ensure risk-based review in the connected business processes and highly interfaced system environments
• Driving positive cultural development within the organization through awareness training on the importance of quality and compliance
• Serving on applicable Program/Project Steering committees and councils for various technology programs (example: Veeva, PV-Argus, Recipe Driven Execution, MES, R&D Technology Program, etc.)

As an innovative thinker, you deeply understand business impact and strongly contribute to joint business success. With your strong ability to ask the right questions, listen and understand your business stakeholders and audience's needs, you successfully identify business potential and strategies. You drive for effectivity and purpose.

Furthermore, you possess the following competencies:

• Relevant University degree
• Pharma/Biotech industry experience with 10+ years of experience in technology-related Quality and /or Computer Validation that directly aligns with the specific responsibilities for this position
• Management of global teams and demonstrated experience influencing senior stakeholders.
• Strong communication and presentation skills adaptable to all team and leadership levels, as well as external partners
• Previous validation and/or quality oversight in Infrastructure and security services in a pharmaceutical environment
• Demonstrative ability in supporting systems of mixed regulated use (example: Platforms shared in GxP and non-GxP business processes)
• Knowledge of Systems Development Life Cycle (SDLC) methodology and ITIL
• Knowledge of and experience in Interfacing with FDA, EMA, TGA, and other key regulatory agencies and their guidelines

This position is open for all CSL Manufacturing sites worldwide.

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.