Associate Director, Quality Risk Specialist
Associate Director, Quality Risk Specialist
Apply locations Boudry - CH, Princeton - NJ - US, Summit West - NJ - US, Devens - MA - US, New Brunswick - NJ - US
Time type: Full time
Posted on: Posted Yesterday
Job requisition id: R1588939
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
The Associate Director, RBQM – HOCT, ICN will mainly be responsible for developing the Quality Narrative at the study and/or ASSET and TA levels to document end-to-end RBQM for critical to quality (CtQ) data, processes, and vendors, demonstrating effective risk and issue management. Provide quality and compliance consultation to clinical trials teams throughout study lifecycle and establish a feedback loop to ensure mitigation strategies are adjusted when new or unanticipated issues arise once the trial has begun.
Key Responsibilities
* Develop the Quality Narrative (or equivalent) at a study and/or ASSET and TA level, to document the end-to-end risk-based quality management for CtQ data, processes and vendors demonstrating effective risk and issue management.
* Partner with Drug Development to embed Quality by Design principles and help identify study specific critical to quality (CtQ) data, processes and vendors.
* Provide feedback on risks to study specific critical to quality factors during trial conduct.
* Conduct spot checks to ensure risk mitigation strategies are accurately translated into operational plans.
* Assist in defining and establishing Acceptable Ranges/QTL and KRIs for CtQ data.
* Provide quality and compliance consultation to clinical trials teams throughout study lifecycle.
* Provide regulatory intelligence on current and upcoming regulations.
* Establish strong partnership with business stakeholders.
* Support the monitoring and evaluation of CtQ factors throughout the study lifecycle.
* Provide R&D Quality expertise and share best practices.
* Ensure rapid communication and escalation of quality issues.
* Ensure compliance with ICH (E8, E6, E9) and other relevant regulatory requirements.
* Engage externally with industry/trade/QA associations, regulatory agencies, and vendors.
Qualifications & Experience
* B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training, and experience.
* Minimum 8+ years QA experience or relevant experience in quality management, biomedical science, clinical development, or regulatory compliance.
Required Competencies:
* Demonstrated applied knowledge of ICH/GCP and regulatory guidelines.
* Experienced in Risk Based Quality Management principles.
* In-depth knowledge of applied risk-management processes.
* Understanding of BMS’s therapeutic areas – HOCT and ICN.
* Demonstrated analytical and conceptual capability.
* Proven problem-solving skills.
* Excellent communication skills.
* Project Management skills to manage complex assignments.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process.
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