Associate Director, Quality Risk Specialist

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. 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.

Job Description

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.
• As part of the upstream protocol authoring process, partner with Drug Development, to embed Quality by Design principles and help identify study specific critical to quality (CtQ) data, processes and vendors and ensure adequate risk mitigation strategies have been implemented.
• During trial conduct, provide feedback on risks to study specific critical to quality factors and ensure mitigation strategies are adjusted when new or unanticipated issues arise once the trial has begun. This will involve partnering with the CAPA CoE and Serious Breach pillar and Clinical Quality Assurance to gather input from audits, inspections, internal quality events, significant issues, and external intelligence to inform QbD.
• At the study level, conduct quality assurance spot checks to ensure risk mitigation strategies are accurately translated into operational plans.
• Assist the business in defining and establishing Acceptable Ranges / QTL and KRIs for CtQ data.
• Support for cause, critical and / or complex quality issues as well as serious breaches for the TA, where deemed necessary.
• Provide quality and compliance consultation to clinical trials teams throughout study lifecycle.
• Provide regulatory intelligence on current and upcoming regulations to ensure we remain compliant with all applicable requirements.
• Establish strong partnership with business stakeholders.
• Partner with the study teams to ensure effective management of significant quality issues / noncompliance and important protocol deviations for CtQ data, processes and vendors.
• Support the monitoring and evaluation of CtQ factors throughout the study lifecycle and adapt Quality plans accordingly.
• Provide R&D Quality expertise, critical thinking, deliver training and share best practices and lessons learned into future trials.
• Ensure rapid communication and escalation of quality issues, including potential misconduct or issues of significant deviations with project / products, to the business and Health Authorities, as needed.
• Ensure compliance with ICH (E8, E6, E9) and other relevant regulatory requirements.
• External engagement as needed with industry / trade / QA associations, regulatory agencies, vendors, and licensing partners as well as pharmaceutical company peers.

Other :

Qualifications & Experience :

Required Competencies :

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an 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. The occupancy type that you are assigned is determined by the nature and responsibilities of your role : Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations / adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation / adjustment prior to accepting a job offer. If you require reasonable accommodations / adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com .

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