Associate Director, Quality Risk Specialist

Associate Director, Rbqm - Hoct, Icn

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.

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 rd 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 :

Compensation overview : devens - ma - us : $175,310 - $212,438 madison - giralda - nj - us : $163,850 - $198,543 new brunswick - nj - us : $163,850 - $198,543 princeton - nj - us : $163,850 - $198,543 the starting compensation range(s) for this role are listed above for a full-time employee (fte) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https : / / careers.bms.com / life-at-bms / . Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following : medical, pharmacy, dental and vision care. Wellbeing support such as the bms living life better program and employee assistance programs (eap). Financial well-being resources and a 401(k). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, global shutdown days between christmas and new year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility / infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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