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

We are currently looking for a

Senior Director, Head of Global Sterility Assurance (m/f/d)

As a successful Senior Director, Head of Global Sterility Assurance you globally oversee all aspects of sterility assurance across CSL Behring including Monitoring Controls, Environmental Monitoring, and Utilities as well validation controls for facilities, equipment, and utilities. You guide the Sterility Assurance organization towards excellent and efficient processes and methods and inspire your community to develop competencies and knowledge. As such, you ensure the growth of your function, your realize Hygiene, process, and facility design, cleaning, and disinfection processes.

As a member of the Global Quality Operations Leadership team, you drive the culture and understanding within CSL Behring across sites and functions Providing a strong strategic direction, you develop tactical and strategic plans for continuous improvement short and midterm.

In detail, your responsibilities include:

Leading the global Sterility Assurance team to ensure compliance with company standards and GMP regulatory guidelines
Ensuring Quality oversight with respect to all aspects related to sterility assurance for manufacturing network as well projects and tech transfers
Providing strategic leadership to global Sterility Assurance Team and key partnering functions in our End-to-End organization, e.g. Engineering, Global and Site Operations, Quality and Quality Control
Ensuring appropriate development, implementation, and maintenance of guidelines, policies, SOPs, and global engineering standards and processes consistent with regulatory requirements and industry standards (quality systems, policies, procedures, and work instructions) related to sterility assurance aspects
Monitoring Controls including Environmental Monitoring, Utilities, in-process testing, and trending
Validation Controls for facilities, equipment, utilities, process, personnel, and methods
Initiating Sterility Assurance concepts for training & behaviors, gowning, Hygiene, process, and facility design, cleaning and disinfection
Developing operational and tactical plans to drive improvements short and mid-term around one of CSLs top Quality risks Sterility Assurance across CSL Behring network and across functions
Developing strategies and driving strategic multi-year sterility assurance roadmap across sites and functions
Supporting Global Regulatory Affairs (GRA) in generating dossiers for submission and assessment of Health Authority requests
Partners closely with and influences and coaches Quality operations, Operations on critical decision making and issue management on the sterility assurance aspects
Partners closely with and influences and coaches Engineering and project teams on sterility assurance aspects
Strong and close partnering and collaboration with stakeholders such as Global Engineering, QA Operations, QA Sterility Assurance, GRA, R&D
Implementation of a learning culture and vertical/horizontal knowledge management

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:

University degree in Engineering or a relevant scientific discipline (Chemistry, Biology, Microbiology, etc.); preferably a Master’s or advanced degree
At least 12 years of experience in the Pharmaceutical/Biotech industry, ideally in a global environment and matrix structure
Highly experienced Professional Leader with significant Sterility Assurance leadership experience, Quality operations, and manufacturing background
Strong leadership competencies including decision making and setting of priorities, change management, people development, and influencing skills
A highly skilled communicator, who inspires the team and key stakeholders on global up to executive levels through clear, concise, and impactful verbal and written communication skills
Excellent solution orientation and an agile, sensitive, and results-oriented mindset
Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, EU, TGA, German, and other regulatory agency guidelines and in manufacturing of biologics
Demonstrated experience in sterility assurance, microbiological control strategies, and concepts
Direct experience executing Quality Assurance functions and systems within a manufacturing and/or engineering context
Excellent interaction capabilities with regulatory authorities including submissions and inspections
Experience
Strong written and verbal communication skills in English; good German skills preferred.

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.

About CSL Behring

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.