Associate Director, Asset Quality New Brunswick NJ
Job Location:
New Brunswick, NJ - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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. Read more: Summary
The Associate Director Asset Quality Lead Hematology Oncology Cell Therapy ICV and Neuroscience will mainly be responsible for developing the Quality Performance Narrative at the ASSET & Trial level 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.
Qualifications & Experience
Education and 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: Knowledge Skills and Abilities
Demonstrated applied knowledge of ICH/GCP regulatory guidelines/directives clinical research processes and principles of Quality Assurance
Very experienced in Risk Based Quality Management principles.
In-depth knowledge of applied risk-management including risk assessment risk analysis risk evaluation risk reporting and communication risk treatment and the review of continuous risk management
Understanding of BMSs therapeutic areas Hematology Oncology Cell Therapy Immunology Cardiovascular and Neuroscience.
Extensive experience in regulatory inspection preparation management and related follow-up.
Demonstrated analytical and conceptual capabilityincluding proficiency in utilizing data and ability to formulate clear business questions that can be answered with data.
Proven problem-solving skills to prevent and overcome complex process and quality related issues during clinical program implementation and execution.
Communication Skills: Communicates professionally clearly concisely and consistently both verbally and in writing to internal and external customers; excellent presentation skills for compelling peer and Senior Management communication.
Project Management: Must be able to manage complex assignments/projects and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.
Considers global influences situations and implications when making plans or decisions solving problems or developing strategies.
Responds resourcefully to changing business conditions and opportunities proactively looking for ways the organization can adapt its plans tactics or strategies.
Fosters a culture in which people continually work to improve services and work processes.
Key Responsibilities:
Develop the Quality Performance 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.
Lead multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline.
Lead and/or contribute to the implementation of large-scale initiatives and/or organizational changes (such as functional optimization) that affect the department.
Act as a highly credible technical/ functional expert; routinely provide technical/functional guidance/coaching to direct and indirect reports/peers within the line or crosslines.
May influence the external environment through interactions with regulators trade associations or professional societies.
Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems.
#LI-HYbrid
If you come across a role that intrigues you but doesnt 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.
Compensation Overview:
Devens - MA - US: $175310 - $212438
Madison - Giralda - NJ - US: $163850 - $198543
New Brunswick - NJ - US: $163850 - $198543
Princeton - NJ - US: $163850 - $198543
Required Experience:
Director
About Company
VetJobs & Military Spouse Jobs works with our employer partners to source, screen, and move qualified talent to the desktops of the Hiring Managers. Application is a two-step process, so please be patient with the team. When you submit to a position on our site your information will ... View more
