Digital Quality Auditor Manager - Now Hiring
You will develop and implement programs to improve product and service quality.
Reporting in to the Head of Digital Quality, you will develop policies, procedures, and methods to check and improve product, material, components and operational quality.
Provide quality oversight during the whole life cycle of computerized systems in scope of GxP regulation and GAMP standards.
You will develop and assess quality and system standards to ensure compliance with company standards and GxP regulatory requirements for computerized systems design, implementation and operation including supplier management.
Oversee quality performance indexes related to computerized systems implementation and operation.
You will shape, direct, and report on supplier/service providers quality activities such as computerized systems, computerized systems validation, to ensure procurements exceed requirements.
Design programs to maintain and improve supplier productivity, and computerized systems validation related activities; ensure customer quality-imposed technical and quality requirements are observed by supplier.
ResponsibilitiesLead supplier/service provider qualification activities involving GxP computerized systems in responsibility of Engineering and I&TCreate training material, act as trainer, and implement training sessions related to computerized systems suppliers/service providers qualificationSupport GxP health authority inspections by serving as subject matter expert for computerized systems supplier/service provider related topicsLead QMS improvements in the area of computerized systems supplier/service provider qualification in collaboration with other departments responsible of supplier/service provider qualificationProvide guidance to project teams, internal stakeholders, and other teams related to supplier/service provider qualificationManage staff of external auditors and serve as primary internal interface and contact for all quality related supplier/service provider issues related to computerized systemsCollaborate with colleagues to manage overall supplier quality auditing program; perform quality audits of approved or potential suppliers/service providerIdentify and use best practices to establish appropriate risk management tools and quality KPI's for local operations/quality groupsBe the Subject Matter Expert for Digital Quality QA-Managers for deviations investigation related to computerized systems supplier/service providerManage activities of computerized systems supplier/service provider quality agreementsQualificationsBachelor's degree or equivalent; education preferably concentrated in IT, Quality, Engineering or Science5
years' quality systems experience in pharmaceutical manufacturing/cGMP regulated environmentKnowledge of current Good Manufacturing Practices (cGMP)Knowledge of FDA and EMA requirements specifically CFR21 part 11 and annex 113
years auditing experience, internal and external, within the industryThe expected base salary range for this position at hiring is $100,000 - $140,000.
Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting.
Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies, and other relevant factors.
In addition to base salary, total compensation for this role may also include incentive compensation and equity.
#LI-RemoteOur BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1.
We are committed to the wellbeing of our employees and their loved ones.
CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters.
Our benefits are designed to support the needs of our employees at every stage of their life.
Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our to see what's available to you as a CSL employee.
About CSL BehringCSL 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.
We want CSL to reflect the world around usAs a global organization with employees in 35
countries, CSL embraces diversity and inclusion.
Learn more about at CSL.
Do work that matters at CSL Behring!.
Estimated Salary: $20 to $28 per hour based on qualifications.
Reporting in to the Head of Digital Quality, you will develop policies, procedures, and methods to check and improve product, material, components and operational quality.
Provide quality oversight during the whole life cycle of computerized systems in scope of GxP regulation and GAMP standards.
You will develop and assess quality and system standards to ensure compliance with company standards and GxP regulatory requirements for computerized systems design, implementation and operation including supplier management.
Oversee quality performance indexes related to computerized systems implementation and operation.
You will shape, direct, and report on supplier/service providers quality activities such as computerized systems, computerized systems validation, to ensure procurements exceed requirements.
Design programs to maintain and improve supplier productivity, and computerized systems validation related activities; ensure customer quality-imposed technical and quality requirements are observed by supplier.
ResponsibilitiesLead supplier/service provider qualification activities involving GxP computerized systems in responsibility of Engineering and I&TCreate training material, act as trainer, and implement training sessions related to computerized systems suppliers/service providers qualificationSupport GxP health authority inspections by serving as subject matter expert for computerized systems supplier/service provider related topicsLead QMS improvements in the area of computerized systems supplier/service provider qualification in collaboration with other departments responsible of supplier/service provider qualificationProvide guidance to project teams, internal stakeholders, and other teams related to supplier/service provider qualificationManage staff of external auditors and serve as primary internal interface and contact for all quality related supplier/service provider issues related to computerized systemsCollaborate with colleagues to manage overall supplier quality auditing program; perform quality audits of approved or potential suppliers/service providerIdentify and use best practices to establish appropriate risk management tools and quality KPI's for local operations/quality groupsBe the Subject Matter Expert for Digital Quality QA-Managers for deviations investigation related to computerized systems supplier/service providerManage activities of computerized systems supplier/service provider quality agreementsQualificationsBachelor's degree or equivalent; education preferably concentrated in IT, Quality, Engineering or Science5
years' quality systems experience in pharmaceutical manufacturing/cGMP regulated environmentKnowledge of current Good Manufacturing Practices (cGMP)Knowledge of FDA and EMA requirements specifically CFR21 part 11 and annex 113
years auditing experience, internal and external, within the industryThe expected base salary range for this position at hiring is $100,000 - $140,000.
Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting.
Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies, and other relevant factors.
In addition to base salary, total compensation for this role may also include incentive compensation and equity.
#LI-RemoteOur BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1.
We are committed to the wellbeing of our employees and their loved ones.
CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters.
Our benefits are designed to support the needs of our employees at every stage of their life.
Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our to see what's available to you as a CSL employee.
About CSL BehringCSL 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.
We want CSL to reflect the world around usAs a global organization with employees in 35
countries, CSL embraces diversity and inclusion.
Learn more about at CSL.
Do work that matters at CSL Behring!.
Estimated Salary: $20 to $28 per hour based on qualifications.
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