Associate Director, Quality Risk Specialist at Bristol-Myers Squibb

Boudry, Neuchatel, Switzerland

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, BiotechnologyIndustries

Requirements

Expertise in risk-based quality management (RBQM) and Quality by Design (QbD) principles
Knowledge of ICH guidelines (E8, E6, E9) and relevant regulatory requirements
Ability to provide quality and compliance consultation throughout clinical trial lifecycle
Strong partnership and collaboration skills with clinical trials teams, Drug Development, CAPA CoE, Clinical Quality Assurance, and business stakeholders
Capability to conduct quality assurance spot checks and support cause analysis for critical/complex quality issues and serious breaches
Regulatory intelligence on current and upcoming regulations
Experience in defining Acceptable Ranges/QTL and KRIs for critical to quality (CtQ) data
Skills in monitoring, evaluating, and adapting quality plans for CtQ factors
Ability to deliver training, share best practices, and lessons learned
Rapid communication and escalation of quality issues, including potential misconduct or significant deviations

Responsibilities

Develop the Quality Narrative (or equivalent) at study, ASSET, and TA levels to document end-to-end RBQM for CtQ data, processes, and vendors, demonstrating effective risk and issue management
Partner with Drug Development during upstream protocol authoring to embed QbD principles, identify study-specific CtQ data, processes, and vendors, and ensure risk mitigation strategies
Provide feedback on risks to CtQ factors during trial conduct, adjust mitigation strategies for new/unanticipated issues, partnering with CAPA CoE, Serious Breach pillar, and Clinical Quality Assurance using inputs from audits, inspections, etc
Conduct quality assurance spot checks at study level to ensure risk mitigation strategies are translated into operational plans
Assist in defining and establishing Acceptable Ranges/QTL and KRIs for CtQ data
Support root cause analysis for critical/complex quality issues and serious breaches at TA level as needed
Provide quality and compliance consultation to clinical trials teams throughout study lifecycle
Provide regulatory intelligence to ensure compliance with applicable requirements
Establish strong partnerships with business stakeholders
Partner with study teams to manage significant quality issues/noncompliance and important protocol deviations for CtQ data, processes, and vendors
Support monitoring and evaluation of CtQ factors throughout study lifecycle and adapt Quality plans
Provide R&D Quality expertise, critical thinking, training, best practices, and lessons learned for future trials
Ensure rapid communication and escalation of quality issues, including to Health Authorities as needed
Ensure compliance with ICH (E8, E6, E9) and other relevant regulatory requirements
Engage externally with industry/trade/QA associations, regulatory agencies, vendors, licensing partners, and peers as needed
Drive quality into the business through proactive measures

Skills

Key technologies and capabilities for this role

RBQMQuality NarrativeRisk-Based Quality ManagementCtQQuality by DesignClinical TrialsComplianceProtocol AuthoringRisk MitigationIssue ManagementDrug Development

Questions & Answers

Common questions about this position

What are the main responsibilities of the Associate Director, Quality Risk Specialist role?

The role focuses on developing the Quality Narrative at study, ASSET, and TA levels to document end-to-end RBQM for critical to quality data, processes, and vendors, providing quality consultation to clinical trials teams, and ensuring risk mitigation strategies are adjusted during trials.

What is the employment type for this position?

This is a full-time position.

What benefits does Bristol Myers Squibb offer?

Bristol Myers Squibb offers a wide variety of competitive benefits, services, and programs that provide employees with resources to pursue their goals at work and in personal lives.

What is the company culture like at Bristol Myers Squibb?

The culture is challenging, meaningful, and life-changing, with uniquely interesting work, opportunities to grow alongside high-achieving teams, and emphasis on balance and flexibility.

What skills or experience make a strong candidate for this role?

Strong candidates will have expertise in risk-based quality management (RBQM), Quality by Design principles, clinical trials quality assurance, regulatory intelligence, and partnering with drug development teams on critical to quality factors.

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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