Associate Director, Business Risk Management and Compliance at Bristol-Myers Squibb

Uxbridge, England, United Kingdom

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

PharmaceuticalIndustries

Requirements

Expertise in executing comprehensive Quality Risk Management (QRM) programs focused on Good Clinical Practice (GCP) compliance across clinical operations
Proficiency in identifying and mitigating emerging business risks using advanced risk assessment principles, methodologies, quality and performance analytics
Ability to foster and promote a culture of Quality Excellence and Inspection Readiness in a multifunctional, matrixed environment
Partnership skills within broader BMS Risk Governance structure, collaborating with R&D Quality, GDO, TA functions, RCO, and Regional Clinical Compliance
Fluency as a data specialist in clinical data analytics, interpretation, and trend discovery for evidence-based decision-making and continuous monitoring
Risk Management specialization, applying advanced principles to proactively identify, assess, and mitigate risks
Capability to assign priority, escalate risks, maintain functional Risk Oversight, monitor mitigation actions, and perform effectiveness checks
Experience developing and executing business risk management strategies to support Inspection Readiness, auditing programs, proactive Compliance Assessments, Quality Control, and Issue Management
Leadership in driving end-to-end Risk Management across scopes (Process global/local; Program/Study; Region/Country/Cluster; Category/Supplier; Investigator/Site)
Participation or leadership in Continuous Improvement projects for process enhancements
Support for strategic direction of Risk Based Management

Responsibilities

Execute a robust, comprehensive, and integrated QRM program addressing business risks
Foster a global, cross-functional Quality Excellence and Inspection Readiness mindset
Promote high-Quality Culture standards by embedding risk management principles and demonstrating business benefits
Monitor GDO performance through assessment of compliance and quality trends using QMS datasets
Apply clinical data analytics for evidence-based decision-making and continuous performance monitoring
Proactively identify, assess, and mitigate risks across clinical operations using advanced techniques
Assign priority to risks and escalate as appropriate
Maintain functional Risk Oversight, monitor delivery of mitigation actions, and conduct effectiveness checks
Develop and execute business risk management strategies supporting Inspection Readiness, global auditing, proactive Compliance Assessments, Quality Control, and Issue Management
Drive end-to-end Risk Management by connecting and escalating emerging signals and risks across scopes (Process; Program/Study; Region/Country/Cluster; Category/Supplier; Investigator/Site)
Lead or participate in Continuous Improvement projects to identify and enable process improvements
Support the strategic direction of Risk Based Management

Skills

QRM

GCP

Risk Assessment

Performance Analytics

Quality Analytics

Inspection Readiness

Risk Governance

Clinical Operations

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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