Manager I&T Computerized System Assurance Operations Team
Updated: 14 Jun 2022
Offered by:CSL Behring
Main responsibilities and Accountabilities:Team Leadership and Management
- Leads a CSA team of contractors to support the defined functions
- Mentors and coaches team members
- Responsible for ensuring adequate support for assigned I&T towers and projects
Audit and Inspection Support Services
- Provides back room support for audits and inspections with the possibility of speaking directly with the auditor/inspector, but this will not be common.
- Maintenance of support materials to facilitate review of systems and services
- Accountable for the timely remediation of audit findings related to IT quality, regulatory compliance and information security
cQMS Compliance Oversight
- Provides guidance to I&T towers and functional groups related to the cQMS
- Works within the global I&T organization and partners with DQ to ensure processes and standards are suitable for the business and are fully compliant with GxP regulations.
- Provides I&T compliance oversight for non-GxP impact systems and will partner with DQ in ensuring compliance for GxP systems
- Train and mentor staff in the principles of SDLC. This may include conducting group training sessions.
- In consultation with DQ and the I&T vernance group, supports the maintenance and ongoing development of procedures to ensure compliance to relevant GxP manufacturing and data integrity regulations.
- Responsible for assuring that corrective and preventative actions for the support area are addressed appropriately and in a timely fashion.
- Ensures cQMS compliance of computer systems through the plan, build, maintenance, and decommissioning phases of the system lifecycle.
- Conducts assessments of functional areas, to identify areas for continual improvement
- Provides overall QA oversight for site infrastructure qualification
- Review/Approval of specified lifecycle documentation
- Ensures his/her team are trained as required
- Dispositions specified I&T Change Controls
- Maintains excellent relationships with I&T and DQ customers, and third-party support partner
Computer Validation Services
- In consultation with DQ and the I&T vernance group, supports the maintenance and ongoing development of CSV procedures.
- Ensures a scientific and risk managed approach is taken toward validation
- Overall accountability for the validation effort
- Determines the validation strategy
- Manages the validation schedule, Validation SMEs, and coordinates testing resources.
- Partners with DQ to provide advice and participates in project team activities with respect to the validation of new and existing computerized business applications and other software systems.
Position Qualifications and Experience Requirements:EducationBachelor’s degree with study in scientific, engineering, or computer systems focus is preferred. Work experience can replace this requirement.Experience
- 5+ years of experience in computer systems compliance
- 2+ year of experience in management
- Demonstrated experience in leading complex, multi-site/functional groups
- Life sciences industry experience preferred but other heavily regulated industry experience is also accepted
- Experience working across a range of countries and cultures
- Expert level kledge of GAMP 5
- Kledge of other lifecycle models is preferred
- Expert level kledge of GxP regulations globally as they pertain to I&T
- Excellent understanding of change management principles, techniques & tools.
- Proven ability to communicate a vision with clear objectives, delineation of responsibilities and qualitative/quantitative measures to executives as well as operational stakeholders.
- Effective facilitation and influencing skills.
- Conflict resolution and negotiation skills.
- od listening and communications skills.
- Analytical mindset and critical thinking.
- Able to cope with pressure.
- Ability to collaborate with others.
- Industry connected through networking and associations; aware of trends and changes to develop direction of future best practices.
Our BenefitsWe 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 CSLCSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL.We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.Do work that matters at CSL!