The role of IT Systems Business Quality Assurance (BQA) is a critical component in ensuring the integrity and reliability of our global IT systems. As a BQA professional, you will play a key part in implementing and maintaining quality systems that align with regulatory requirements.
Key Responsibilities:
* Safety and Efficacy Quality System (SEQS): Ensure local implementation of SEQS, review regional and/or local SOPs versus global policies, provide quality oversight for compliance to SEQS, and escalate compliance issues to management as necessary.
* Inspection Readiness: Assist in interpreting relevant pharmacovigilance regulations and guidelines, perform quality self-assessments, facilitate audits and inspections, coordinate audit responses, and communicate inspection readiness requirements.
* Quality Plan Implementation: Document regional and/or affiliate quality systems requirements, manage quality plan(s), provide updates to quality and business owners, implement and maintain quality systems, and consult on root cause analysis for deviations.
Requirements:
* Bachelors or Masters Degree in a science or healthcare-related field.
* Minimum three years' experience in quality and/or data management or statistics.
* Demonstrated ability to implement, interpret, and apply quality systems within a regulated work environment.
* Excellent communication and influencing skills, with the ability to prioritize and handle multiple concurrent tasks.
About Us:
We are a global organization committed to making life better for people around the world. We are dedicated to providing equal opportunities to individuals with disabilities and promoting diversity, equity, and inclusion in all aspects of our work.