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

Uxbridge, England, United Kingdom

Bristol-Myers Squibb Logo
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

Key technologies and capabilities for this role

QRMGCPRisk AssessmentPerformance AnalyticsQuality AnalyticsInspection ReadinessRisk GovernanceClinical Operations

Questions & Answers

Common questions about this 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 both at work and in their personal lives.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What salary can I expect for this role?

This information is not specified in the job description.

What key skills are required for the Associate Director role?

Key skills include expertise in Quality Risk Management (QRM), clinical data analytics and trend discovery, advanced risk assessment principles, and fostering cross-functional quality culture.

What is the company culture like at Bristol Myers Squibb?

The culture emphasizes challenging, meaningful, life-changing work with high-achieving teams, work-life balance, flexibility, and promoting a high-Quality Culture standard through proactive risk management.

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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