Manager, QA IT

Responsibilities:

• Under general direction provides support on Quality systems to ensure compliance with company standards and GMP regulatory guidelines

• Develops maintains and improves GMP-related quality control systems including standard operating procedures (SOPs)

• Participates in project teams to provide review and approval of project Validationdocumentation according to applicable approval matrix or procedures

• Supports quality systems related to Validation LIMS Calibration Document Management Deviation Management CAPA Change Control and Enterprise Learning Management

• Writes and manages validation plans ensuring appropriate timely validation/revalidation is maintained

• Conducts internal audits and assists with 3rd party quality audit; plans and implements continuous improvement projects

• Supports GxP health authority inspections by serving as subject matter expert forcomputerized systems topics

• Provides guidance on quality and regulatory requirements to project teams internal stakeholders and other teams on GxP compliance relating to computerized systems

• Collaborates to resolve technical issues provide quality training and communicate best practices

Qualifications:

• Bachelor degree in Engineering or a relevant scientific discipline (Chemistry Biology Microbiology IT etc.) or equivalent experience

• 5 years quality systems experience in pharmaceutical manufacturing/cGMP regulated environment

• Knowledge of current Good Manufacturing Practices (cGMP)

• Knowledge of FDA and EMA requirements

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients needs by using the latest technologies we discover develop and deliver innovative therapies for people living with conditions in the immunology hematology cardiovascular and metabolic respiratory and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation recombinant protein technology and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being CSL.

You Belong at CSL

At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process please visit Experience:

Manager