Head Sterility Assurance

  • BioTalent
  • Bern, Bern, Switzerland
  • 15/06/2020
Full time Data Science Data Analytics Big Data Statistics

Job Description

With operations in 35+ nations and ~ 22,000 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!

Job Description

For our site in Bern (Or Marburg/Germany, Kankakee/USA) and within the Global Quality Operations business unit, we are looking for a:

Director, Head of Global Sterility Assurance

Reporting to the VP Operational Quality, the Director Sterility Assurance will provide microbiological oversight across all CSL Behring Manufacturing sites, including CSL Plasma Union site and CMOs, to assure that consistent standards for sterility assurance practices are applied across the network.

On this role, you will ensure that sterile manufacturing operations, i.e. processes and facilities meet the required standards in line with international regulations, global policies and SOPs. You will be responsible for significant sterility assurance investigations at each location ensuring a consistent risk assessment approach is used and will be able to provide global direction when issues arise and ensure that all actions taken are fully documented to support follow up investigations.

Further, you should be able to evaluate comple data, derive conclusions, and communicate crisp results to key stakeholders globally, but also have a global view of sterility assurance and the ability to identify risks, trends and related mitigation strategies across sites and CMOs. This role is Global in nature and you will lead the Sterility Assurance SMEs across the network to assure standardized processes and best practices for the QA function. There will be approimately 40% travel foreseen on this role.

Responsibilities:

Develop and oversee the standards for the sterility assurance aspects of the Quality System and ensure their implementation across the network:

    • Implement, maintain and continuously improve globally, the sterility assurance standards of the Quality System. These standards include but are not limited to:
    • Facility cleanliness zones incl. personnel and material flow concepts
    • Hygiene incl. gowning, cleaning and disinfection concepts
    • Clean-room behavior and aseptic techniques, operator training and qualification concepts
    • Raw material test concept
    • Environmental and utilities monitoring concepts
    • In-process control concepts and contamination control strategies
    • Sterilization and aseptic processing concepts
    • Process simulations (media fill/hold studies) concepts
    • Container closure integrity concept
    • Investigation standards for sterility test and media fill failures
    • Investigation standards for bioburden and microbial environmental / utilities monitoring ecursions
    • Develops and oversees consistent trending systems
    • Develops an escalations system for trends and critical issues
    • Design, implement and own the sterility assurance risk assessment process at each manufacturing site and CMOs.
    • Present key trends, risks and issues at the Global Manufacturing Quality Management Review.
    • Maintain and share knowledge of changes in regulatory authority requirements.


Coordinate and provide consultation on Sterility Assurance across the network:

    • Provide subject matter epertise on sterility assurance best practices and mitigation strategies.
    • Input into the selection of CMOs and provide appropriate oversight
    • Contribute to sterile area design, layouts and process flows with Global Engineering
    • Enable cross functional collaboration/communications on sterility assurance issues across Quality Assurance, the laboratories, Global Engineering and the Manufacturing areas as required. Lead, develop and maintain a Global Community of Standardization epert team for sterility assurance across the network
    • Evaluate significant deviations from a sterility assurance and QA perspective to identify risks, trends and mitigation strategies that should be implemented across sites
    • Respond to health authority information requests and inspection observations concerning sterility assurance matters
    • Develops and supports consistent training connected to sterility assurance
    • Support Sterility Investigations across sites and escalate emerging trends to key stakeholders
    • Identify sterility and bio burden issues that present a risk or a trend across sites; escalate emerging trends to key stakeholders and relevant functions.
    • Ensure each site has a process to ensure that all of operational areas are fully aware of results obtained and trends that are developing ensuring that they have the opportunity to contribute to root cause investigations.


Thought leadership on eisting and emerging regulations and eternal best practices related to areas of Sterility Assurance:

    • Understand new/updated regulations and best industry practices and track trends affecting sterility assurance
    • Ensure that staff are educated on regulatory trends and implications
    • Educate senior leadership on regulations, best industry practices and respective trends and the impact on operations, including CMOs
    • Represent CSL Behring at eternal industry groups for sterility assurance and introduce best practices and standards from these groups

Provide Global Sterility Assurance team leadership:

    • Provide leadership and guidance to the team of Sterility Assurance SMEs to effectively eecutive on Quality Assurance strategies and programs
    • Set objectives and provide clear direction for eecution by the SMEs with respect to sterility assurance

Your profile:

  • Graduate level in a related discipline (Microbiology, Virology, Biochemistry, and Pharmaceutical Sciences). Masters/Doctorate Qualification preferred
  • Minimum of 6 years' eperience in industrial sterility assurance processes
  • Minimum of 3 years' eperience leading a team with some global input
  • cGMP background in the Pharmaceutical industry
  • Eperience of Quality Control microbiological testing techniques and industry practices
  • Business fluency in English
  • Proven time management skills for planning and schedule of work
  • Leadership skills in supervision of teams
  • Knowledge of continuous improvement techniques and advanced root cause analysis techniques
  • Demonstrated ability to influence at all organizational levels through clear, concise and impactful verbal and written communication skills
  • In-depth knowledge of cGMP's, FDA, TGA, EU and other relevant GP regulations
  • Maintain in-depth knowledge of pharmaceutical manufacturing industry standards through active engagement in industry associations, e.g. PDA, ISPE etc.
  • Effective presentation and meeting skills within all levels of the organization and with eternal colleagues and collaborators
  • Ability to influence and motivate others while maintaining a cohesive team environment