Director, Inspection Readiness at Bristol-Myers Squibb

New Brunswick, New Jersey, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceutical, Biotechnology, Cell Therapy, Medical DevicesIndustries

Requirements

Bachelor’s degree in Natural Science, Pharmacy, or related fields
10+ years of relevant experience in regulatory affairs, compliance, or quality assurance in the pharmaceutical, biotech, cell therapy, and medical device industries
Minimum of 5 years’ experience as a Consumer Safety Officer (CSO) or in a similar role at the US Food & Drug Administration (FDA), with FDA employment within the past 10 years (2015-2025)
Extensive experience conducting inspections in pharmaceutical (medical device, biologics) facilities
In-depth knowledge of global regulatory requirements

Responsibilities

Support the Senior Director of Inspection Readiness to develop, implement, and continuously enhance the Global Quality inspection readiness strategy and framework
Conduct mock inspections, gap analyses, and assessments of inspection readiness for facilities and business units
Monitor regulatory intelligence, trends, and changes, integrating Predictive Quality insights to adapt inspection readiness strategies and maintain proactive compliance
Consolidate and analyze regulatory observations and lessons learned to inform continuous improvement and prevent repeat observations
Support the Senior Director as an expert advisor and point of contact for site guidance during regulatory inspections, providing real-time support, high-level oversight of inspection conduct, response management, remediation activities, and direct communication with regulatory agencies
Collaborate with cross-functional stakeholders to ensure integrated inspection preparedness across all business units
Analyze inspection outcomes and drive post-inspection improvement initiatives
Work with site principals to ensure effective, local Inspection Readiness plans are developed and maintained
Develop robust metrics that best measure the performance of the Inspection Readiness program and that measures the overall inspection preparedness of the BMS Network
Champion a culture of compliance, quality, and continuous improvement throughout the organization
Responsible for the management and execution of the GROe process
Advise on compliance matters by providing guidance on regulatory notifications, escalation of events, and readiness for regulatory inspections
Establish and maintain a network of industry contacts to benchmark and adopt best practices in inspection readiness

Skills

FDA regulations

EMA regulations

PMDA regulations

Inspection readiness

Mock inspections

Gap analysis

Regulatory intelligence

Predictive Quality

Quality compliance

Pharmaceutical operations

Biotech operations

Cell therapy

Medical devices

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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