Head of Digital Quality
CSL Behring
Bern, CH
vor 2 Tg.
source : DirectEmployers Association

With operations in 35+ nations and 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza.

Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.CSL is the parent company of CSL Behring and Seqirus.

CSL Behring () is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.

CSL Behring operates CSL Plasma () , one of the world's largest collectors of human plasma, which is used to create CSL's therapies.

Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!CSL Behring is a global biotherapeutics leader driven by its promise to save lives.

In Bern more than 1500 employees develop and deliver life-saving therapies to treat people with rare and serious medical conditions worldwide.

We are currently looking for a Director of Digital Quality (m / f / d) 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 guidelinesWorker Type : EmployeeWorker Sub Type : RegularR-134378 CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law.
  • CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https : / /

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