Associate Director, Inspection Readiness at Bristol-Myers Squibb

Lawrence Township, New Jersey, United States

Bristol-Myers Squibb Logo
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, BiotechnologyIndustries

Skills

Key technologies and capabilities for this role

GMPGDPInspection ReadinessRegulatory ComplianceQuality MetricsRisk-Based ApproachCompliance MonitoringGlobal Regulatory InspectionsContinuous ImprovementMatrixed Organization

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 on-site work?

The role involves supporting on-site and remote assessments of BMS internal and external sites, and the company recognizes the importance of balance and flexibility in the work environment.

What are the key responsibilities for this role?

Key responsibilities include monitoring global regulatory inspection outcomes and compliance metrics to shape inspection readiness strategies, cultivating partnerships with cross-functional teams, conducting enterprise reviews of regulatory interactions, and serving as a subject matter expert on regulatory requirements.

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 a focus on balance and flexibility.

What makes a strong candidate for the Associate Director, Inspection Readiness role?

Strong candidates will have expertise in GMP/GDP inspection readiness, experience monitoring regulatory trends and compliance metrics, and the ability to collaborate extensively in a matrixed organization across the BMS network.

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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