Executive Director Quality Systems & Compliance at Bristol-Myers Squibb

Seattle, Washington, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Expertise in ensuring robust compliance with global regulations, BMS policies, and industry standards across cell therapy activities
Ability to oversee implementation and continuous improvement of compliance programs for development and commercial programs
Experience driving strategic compliance initiatives in partnership with cross-functional teams (e.g., Process Development, Analytical Development, Global Manufacturing Science and Technology, Business Process Management, Internal and External Manufacturing, Regulatory Affairs, Brand Teams, Legal, Patient Safety, Medical Affairs, Clinical Therapeutic Area Quality)
Proven capability in proactively identifying and assessing regulatory and quality risks
Leadership skills to lead a team dedicated to maintaining global compliance across the cell therapy network
Strong communication and decision-making abilities as the primary compliance authority for cell therapy within BMS
Networking experience across internal and external quality organizations to develop and implement compliant solutions
Ability to foster a culture of quality and regulatory excellence

Responsibilities

Partner with Cell Therapy Development, Operations, and Franchise organizations, as well as matrix teams, to ensure alignment with annual compliance objectives and clearly defined roles and responsibilities
Lead the team of Cell Therapy local Process Owners in maintaining and enforcing Governance Controls for processes, including Management Responsibility, Event Management, Change Management, and Quality Risk Management, with a primary focus on regulatory compliance
Oversee Disposition (including ERP Quality system requirements) and Field Action processes to ensure strict adherence to compliance standards
Provide end-to-end oversight of Cell Therapy post-market compliance activities, including ownership of the Product Complaints Program for investigational and commercial complaints in all markets, ensuring timely and compliant resolution in accordance with regulatory requirements
Serve as the Cell Therapy compliance lead for ongoing oversight and guidance on QMS implementation and continuous improvement to ensure compliance across Cell Therapy Development, Operations, and Franchise
Own and manage the Cell Therapy compliance programs

Skills

Quality Compliance

Cell Therapy

Regulatory Compliance

GMP

Risk Assessment

Quality Assurance

Process Development

Manufacturing Compliance

Regulatory Affairs

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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