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Associate Director, Therapeutic Area Quality - Job Opportunity at Bristol Myers Squibb

Boudry, Switzerland
Full-time
Senior
Posted: April 2, 2025
Hybrid
USD 150,000 - 180,000 annually based on location and role scope

Benefits

Competitive healthcare and benefits package aligned with industry standards
Professional development and career growth opportunities
Work-life balance initiatives including flexible work arrangements
Comprehensive wellness programs supporting employee health

Key Responsibilities

Lead development and implementation of clinical audit strategies for multiple therapeutic areas
Direct oversight of internal and external clinical trial site audits
Strategic risk management and quality assurance planning
Cross-functional leadership in quality systems implementation
Regulatory compliance and health authority interaction management

Requirements

Education

B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field

Experience

Minimum 10 years QA experience or relevant experience in medical quality management

Required Skills

ICH/GCP regulatory knowledge Clinical research and pharmacovigilance expertise Risk management proficiency Therapeutic area understanding Regulatory inspection management Data analysis capabilities Problem-solving skills Professional communication abilities Project management expertise Global business acumen
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Sauge AI Market Intelligence

Industry Trends

Increasing focus on cell therapy and innovative treatment modalities requiring specialized quality oversight Growing complexity in clinical trial designs driving demand for sophisticated audit strategies Rising regulatory scrutiny in therapeutic areas like oncology and immunology

Role Significance

Typically leads a team of 5-8 quality professionals while coordinating with multiple cross-functional teams
Strategic leadership position with significant influence on clinical trial quality and regulatory compliance

Key Projects

Clinical trial site audit program development Quality system implementation across therapeutic areas Regulatory inspection preparation and management Risk-based quality strategy development

Success Factors

Strong understanding of clinical research processes and regulatory landscape Ability to build effective partnerships across multiple stakeholders Strategic thinking in risk assessment and mitigation Excellence in project management and team leadership

Market Demand

High demand role due to expanding clinical trial complexity and increasing regulatory requirements in pharmaceutical industry

Important Skills

Critical Skills

Quality assurance expertise with specific focus on clinical trials Risk management and strategic planning capabilities Strong regulatory knowledge and inspection management experience

Beneficial Skills

Experience with cell therapy and innovative treatment modalities Change management and organizational development skills Digital quality systems expertise

Unique Aspects

Opportunity to work across multiple therapeutic areas including emerging cell therapy field
Direct impact on global clinical trial quality standards
Significant interaction with regulatory authorities and industry peers

Career Growth

2-4 years in role before advancement, depending on performance and organizational growth

Potential Next Roles

Director of Global Quality Assurance Head of Clinical Quality Vice President of R&D Quality

Company Overview

Bristol Myers Squibb

Global biopharmaceutical leader focused on innovative medicines in oncology, hematology, immunology and cardiovascular disease

Top-tier pharmaceutical company with strong market position and extensive R&D pipeline
Strategic European location with significant R&D operations
Innovation-driven environment with strong emphasis on collaboration and scientific excellence
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