QAO Support Owner

QAO Support Owner

Overview

Provides oversight for development and maintenance of quality programs, systems, processes and procedures to ensure compliance with company standards and regulatory guidelines. Leads preparation for audits/inspections and resolution of findings; liaises with auditing groups and inspectors throughout audits. Coordinates legal requests in support of government investigations or litigations. Ensures quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide, sharing of best practices, and achievement of the company's mission globally.

Key Responsibilities:

• Under general direction, leads/coordinates Quality Assurance activities in accordance with cGMP standards
• Ensures compliance with established internal specifications, standard operating procedures (SOP) and government regulations
• Coordinates and manages complex deviations, task forces and communication to ensure compliant release system for corresponding market
• Responds to questions from authorities (Swissmedic, FDA, etc.) to ensure timely product release
• Supports submission of test samples, certificates and batch documentation for authorities (Swissmedic, FDA, etc.)
• Initiates changes to SOPs when a deviation from regulation is identified, or a system
• Supports GMP Maintenance & Utilities to ensure adherence and conformance to all relevant deliverables

Education:

• University degree in a relevant scientific discipline (Microbiology, Chemistry, Biology, Biochemistry)

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Qualifications

• Experience within a global matrix organization
• Knowledge of current Good Manufacturing Practices (cGMP) principles
• Knowledge of appropriate regulatory requirements Qualifications
• Applies advanced knowledge of job area typically obtained through a 3-4 year University Degree and work experience
• May manage projects/processes, working independently with limited supervision• Coaches and reviews the work of lower level professionals
• Problems faced are difficult and sometimes complex, often requiring understanding of broader set of issues

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

Our Benefits

We 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.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.