Global Lead, Sterility Assurance - Monitoring Controls
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 one of the largest influenza vaccine companies 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!
Reporting into the Global Director Sterility Assurance, the Leader, Quality Sterility Assurance Monitoring Control will be responsible for the Quality oversight for microbial contamination control monitoring elements including Environmental and Personnel monitoring, raw material testing, in-process testing, management of methods and pest control.
The individual will be accountable for all sterility assurance global monitoring control governance and life cycle management at all CSL Behring sites.
- The incumbent will have demonstrated strong technical knowledge in the above areas of microbial monitoring of aseptic cleanroom facilities, life cycle management and cGMP compliance. They will be experienced in regulatory requirements and submissions and have experience in associated regulatory inspections. They will be responsible for QA oversight of quality standards and systems aligned with the Sterility Assurance function in the above areas.
- This role will be responsible for the following: providing governance of all microbial monitoring controls, providing governance of microbial testing strategies for environmental and personnel monitoring, including rationales for testing programmes, generation of alert and action limits, microbial trending strategies as well as method validation for EM sampling plates, incubation strategies and agar plate neutralizer justification. S/he will also be responsible for providing guidance in the pest control programme
- The role also requires providing expertise during root cause analysis investigations including OOL investigations, bioburden, endotoxin and sterility test failures as well providing support as the SME during external regulatory inspections.
- The incumbent will implement a learning culture and will ensure a vertical and horizontal knowledge management
- The incumbent will be the Quality partner to the teams within Sterility Assurance and work closely with members of the Global Sterility Assurance peers of the corresponding teams as well as the local site Sterility Assurance leads. S/he will also partner to the corresponding Value Stream QA Team.
- The incumbent will work closely with his or her peers in Quality Sterility Assurance from the other manufacturing sites and ensure that the same principles and systems are applied across all CSL Behring manufacturing sites and that in all areas the appearance and reporting of the documentation in the stated areas is standardized.
- The position requires the ability to build and maintain strong relationships and collaborate effectively with all levels and cross functionally within the organization.
Provide Quality Assurance governance for the microbial Monitoring controls
- Collaborate with internal partners for the design of best practice environmental and personnel monitoring programmes – to deliver on time and to the required standards and regulatory requirements.
- Provide a consistent quality approach to the environmental monitoring programme to include justification of the media to use and frequency of monitoring.
- Define a risk-based approach to the sample site selections for the sites
- Provide governance in how to set alert and action limits for microbial data and the trending frequencies and format in accordance with a risk-based approach
- Define an objectionable organism strategy and trend policy.
- Ensure that all in-process testing (bioburden, endotoxin) and final product testing (sterility testing) complies with pharmacopeial expectations
- Responsible for Quality decisions for capital projects in area of consultation with global SA and local QA Operations leaders.
- Review and evaluate the use of rapid microbiology methods and new technology to improve the microbial monitoring controls
- Support regulatory document submissions and pre-approval inspections.
- Support internal and external audits as SME
- Provide leadership and expertise to the local SA team.
Provide Quality Assurance Oversight for Sterility Assurance Monitoring Control Standards and Knowledge Management in Monitoring Control
- Ensures appropriate development, implementation and maintenance of global monitoring control standards and processes consistent with regulatory requirements and industry standards (quality systems, policies, procedures and work instructions).
- Participate in major deviations as SME and ensure compliance of the final deviation reports.
- Responsible for the generation of the documentation in the above areas, ensure compliance to GMP and that required standards are met. Ensure a harmonized appearance of all documentation across the global network.
- Ensure that global standards are met for best practice and validation
- Facilitate global and local change controls
- SME representative for all microbiological monitoring
- Contribute to internal and authority pre- and post-approval inspections
- Provide QA oversight to APQR/PQR Follow up actions.
If team lead function is included (depends on size and complexity):
Provide local Sterility Assurance Quality team leadership
- Work collaboratively with the Global SA team to provide a holistic microbial contamination control strategy at each of the CSL Behring Manufacturing sites.
- Provide leadership and guidance to a local team of Sterility Assurance Quality professionals at the CSL Behring global manufacturing sites
- Set governance, objectives and provide clear direction for execution.
- Provide input for organizational design and staffing decisions.
- Train and develop the local Sterility Assurance Quality team.
- Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
Degree in Microbiology/Life Sciences
- +10 years of experience as professional in the pharmaceutical industry or equivalent combination of education and experience.
- Extensive professional experience in leading (project) teams
- Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, EU and other regulatory agency guidelines.
- Experience in the manufacturing of biologics
- Direct experience of QA oversight of microbial monitoring of aseptic manufacturing areas.
- Direct experience executing Quality Assurance function and system within a manufacturing and QC Microbiology/Sterility Assurance context.
- Experience in interacting with regulatory authorities including submissions and inspections.
- Experience in working in a global environment
- QC Microbiology experience desirable