Associate Director, Senior Quality Auditor
Associate Director, Senior Quality Auditor United States of America R-219133 2012 CSL Behring L.
L.
C.
Job Description As Associate Director, Senior Quality Auditor, you will report into the Director of Internal Audits and Compliance.
You will be responsible for the Execution of Quality Internal/Corporate Auditing (GXP:
GMP (pharmaceuticals, medical devices, and combination products), GDP, GVP and GCP) across all CSL business units, executing as lead and co-auditor.
Work independently, challenge the status quo, identifies gaps and risks and drives process improvements using appropriate Auditing, Process Excellence and Quality Risk Management tools.
Ensure an inspection-ready state of compliance and monitors process performance metrics to ensure the effectiveness and improvement of the Quality Management System.
Develop Internal Audit training for qualified auditors, SMEs and CSL associates.
You will set up cross functional teams of auditors and SMEs.
Audits are conducted on site, virtual or hybrid.
This role is responsible for the corporate Internal Audit program.
Responsibilities specific to the process may include:
o Generate or support one consolidated and risk based global annual Quality Internal Audit Program/Process to monitor implementation and compliance with GxP principles for established or revised business processes.
o Annually develops a global risk-based auditing plan and utilizes tools and measurements needed to report effectiveness of the plan and robustness of underlying business processes.
o Organize remote, hybrid or onsite audits.
o Develop a program for inspection readiness determinations, including rehearsals for health authority inspections.
o Provide coaching before and during inspections.
o Build a network of auditors who can support a variety of assignments across External Audits, Supplier Audits, Self-Inspections, and Internal Audits within CSL and with contract auditors.
o Communicate identified deficiencies and compliance risks to leadership in the impacted business operations and quality units.
o Monitor performance metrics on the audit program, and drive process improvements to the auditing quality system.
You will collaborate across all GxP sites and teams, local and global Quality Assurance and Quality Control functions, local site or function Quality associates, Affiliates, Manufacturing, R&D and others in CSL Behring, CSL Plasma, CSL Vifor and CSL Seqirus to ensure appropriate audit preparation, execution and follow up.
You will have a direct contact partner for Quality Operations including manufacturing sites; Affiliate Quality network; R&D; Global Engineering and other relevant stakeholders.
As part of a global organization, you will travel approximately 40 %, globally and locally.
We ask that you have in depth knowledge about current inspection practice from the major Health Authorities, with priority on USFDA, experience inspecting for the USFDA and broad current experience in auditing.
o Bachelor's Degree in related field o 5
years' direct experience with Quality Auditing or conducting inspections.
o 5
years' experience in a pharmaceutical or biopharmaceutical company.
o 5
years' experience working at an Inspectorate, preferably USFDA.
o Direct experience executing Quality Assurance/Quality systems activities required.
o Experience interacting with regulatory authorities including regulatory inspections.
o Deep knowledge in GXP, (GMP (pharmaceuticals, medical devices, and combination products), GDP, GVP and GCP).
o Experience working in an international organization across borders.
About UsWe encourage you to make your well-being a priority.
It's important and so are you.
Learn more about how we care at CSL.
CSL 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 CSL Behring.
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 Behring! Share:
State/Province Pennsylvania City King of Prussia Street Address 1020 First Avenue Primary Location CSL Behring King of Prussia Full Time/Part Time Full Time Equal Opportunity EmployerCSL 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 click below.
#J-18808-Ljbffr Recommended Skills Biopharmaceuticals Business Processes Leadership Measurement And Metrology Medical Material Performance Management Estimated Salary: $20 to $28 per hour based on qualifications.
L.
C.
Job Description As Associate Director, Senior Quality Auditor, you will report into the Director of Internal Audits and Compliance.
You will be responsible for the Execution of Quality Internal/Corporate Auditing (GXP:
GMP (pharmaceuticals, medical devices, and combination products), GDP, GVP and GCP) across all CSL business units, executing as lead and co-auditor.
Work independently, challenge the status quo, identifies gaps and risks and drives process improvements using appropriate Auditing, Process Excellence and Quality Risk Management tools.
Ensure an inspection-ready state of compliance and monitors process performance metrics to ensure the effectiveness and improvement of the Quality Management System.
Develop Internal Audit training for qualified auditors, SMEs and CSL associates.
You will set up cross functional teams of auditors and SMEs.
Audits are conducted on site, virtual or hybrid.
This role is responsible for the corporate Internal Audit program.
Responsibilities specific to the process may include:
o Generate or support one consolidated and risk based global annual Quality Internal Audit Program/Process to monitor implementation and compliance with GxP principles for established or revised business processes.
o Annually develops a global risk-based auditing plan and utilizes tools and measurements needed to report effectiveness of the plan and robustness of underlying business processes.
o Organize remote, hybrid or onsite audits.
o Develop a program for inspection readiness determinations, including rehearsals for health authority inspections.
o Provide coaching before and during inspections.
o Build a network of auditors who can support a variety of assignments across External Audits, Supplier Audits, Self-Inspections, and Internal Audits within CSL and with contract auditors.
o Communicate identified deficiencies and compliance risks to leadership in the impacted business operations and quality units.
o Monitor performance metrics on the audit program, and drive process improvements to the auditing quality system.
You will collaborate across all GxP sites and teams, local and global Quality Assurance and Quality Control functions, local site or function Quality associates, Affiliates, Manufacturing, R&D and others in CSL Behring, CSL Plasma, CSL Vifor and CSL Seqirus to ensure appropriate audit preparation, execution and follow up.
You will have a direct contact partner for Quality Operations including manufacturing sites; Affiliate Quality network; R&D; Global Engineering and other relevant stakeholders.
As part of a global organization, you will travel approximately 40 %, globally and locally.
We ask that you have in depth knowledge about current inspection practice from the major Health Authorities, with priority on USFDA, experience inspecting for the USFDA and broad current experience in auditing.
o Bachelor's Degree in related field o 5
years' direct experience with Quality Auditing or conducting inspections.
o 5
years' experience in a pharmaceutical or biopharmaceutical company.
o 5
years' experience working at an Inspectorate, preferably USFDA.
o Direct experience executing Quality Assurance/Quality systems activities required.
o Experience interacting with regulatory authorities including regulatory inspections.
o Deep knowledge in GXP, (GMP (pharmaceuticals, medical devices, and combination products), GDP, GVP and GCP).
o Experience working in an international organization across borders.
About UsWe encourage you to make your well-being a priority.
It's important and so are you.
Learn more about how we care at CSL.
CSL 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 CSL Behring.
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 Behring! Share:
State/Province Pennsylvania City King of Prussia Street Address 1020 First Avenue Primary Location CSL Behring King of Prussia Full Time/Part Time Full Time Equal Opportunity EmployerCSL 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 click below.
#J-18808-Ljbffr Recommended Skills Biopharmaceuticals Business Processes Leadership Measurement And Metrology Medical Material Performance Management Estimated Salary: $20 to $28 per hour based on qualifications.
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