Associate Director, Quality Risk Specialist

Bristol-Myers Squibb; Boudry; Vor Ort; CHF 100’000 - 160’000; Vollzeit

Zusammenfassung

An established industry player is seeking an Associate Director to lead quality management initiatives in clinical trials. This role involves developing comprehensive Quality Narratives and ensuring compliance with regulatory standards. You'll collaborate with cross-functional teams to embed Quality by Design principles, adapt strategies based on real-time feedback, and drive continuous improvement in quality processes. Join a dynamic organization where your expertise will directly impact patient outcomes and contribute to groundbreaking advancements in healthcare. If you have a passion for quality assurance and a commitment to excellence, this opportunity is tailored for you.

Leistungen

Flexible working hours

Comprehensive health benefits

Professional development opportunities

Employee wellness programs

Qualifikationen

• 8+ years of QA experience in clinical development or regulatory compliance.
• Demonstrated knowledge of ICH/GCP and risk-based quality management principles.

Aufgaben

• Develop Quality Narratives to document end-to-end risk-based quality management.
• Provide quality consultation to clinical trial teams throughout the study lifecycle.

Kenntnisse

Quality Assurance

Risk Management

Regulatory Compliance

Analytical Skills

Project Management

Communication Skills

Ausbildung

B.S. in Chemistry

M.S. in Biology

Health or Quality related field

Jobbeschreibung

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.

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, in particular the CORM function, 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.
• At the study level, conduct 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.
• 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.
• 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.

Other

• Drive quality into the business through proactive quality support, mentoring and/or coaching and consultation.
• Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level.
• 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 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.
• Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems.

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 BMS’s therapeutic areas – HOCT and ICN.
• Extensive experience in regulatory inspection preparation, management, and related follow-up.
• Demonstrated analytical and conceptual capability—including 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.