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Senior Risk Management Specialist
vor 2 Wochen
We are seeking a highly skilled Senior Risk Management Specialist to join our team at Bristol-Myers Squibb. As a key member of our quality assurance department, you will play a critical role in ensuring the delivery of high-quality products and services that meet regulatory requirements.
About the RoleThis position involves working closely with our drug development teams to develop and implement quality management strategies that mitigate risks associated with product development and manufacturing. The successful candidate will have a strong background in quality assurance and risk management, with excellent analytical and problem-solving skills.
Bristol-Myers Squibb is committed to providing our employees with a comprehensive benefits package, including competitive salary, stock options, and retirement savings plans. We also offer flexible work arrangements and opportunities for professional development and growth.
Responsibilities
- Develop and implement quality management strategies to mitigate risks associated with product development and manufacturing
- Partner with drug development teams to embed Quality by Design principles and identify critical to quality data, processes, and vendors
- Provide quality and compliance consultation to clinical trials teams throughout the study lifecycle
- Establish a feedback loop to ensure mitigation strategies are adjusted when new or unanticipated issues arise
Qualifications
- Bachelor's degree in Chemistry, Biology, or Health-related field or equivalent combination of education and experience
- Minimum 8+ years QA experience or relevant experience in quality management, biomedical science, clinical development, or regulatory compliance
- Demonstrated applied knowledge of ICH/GCP and regulatory guidelines
- Experienced in Risk Based Quality Management principles
- In-depth knowledge of applied risk-management processes