Senior Manager, QA Disposition Material Review Board in Devens, MA at Bristol-Myers Squibb

Devens, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Experience with Material Review Board (MRB) processes for non-conforming material in a cGMP environment
Knowledge of BMS policies, standards, procedures, and Global cGMP
Ability to oversee atypical events and ensure management notifications per procedure
Capability to coordinate with stakeholders including QA Disposition, QA/QC/MST Investigations, Medical, Legal, senior site leadership, and product level teams
Proficiency in acting as MRB Chair, facilitating accurate and timely MRB processes, including material conversion
Experience in maintenance and review of SOPs
Familiarity with commercial and clinical manufacturing for cell therapy products
Availability for M-F, standard working hours in Devens, MA

Responsibilities

Coordinate and prepare for Material Review Board (MRB) meetings by monitoring quality events and impact assessments, supporting the MRB Coordinator, reviewing/drafting Pre-MRB Notifications, and scheduling meetings/deliverables
Oversee/review coordination and compilation of MRB content for presentation to senior leadership, medical affairs, legal, and other stakeholders related to potentially non-conforming lots
Coordinate, co-author, and review Integrated Health Hazard Assessment (IHHA) documents as needed
Chair MRB meetings and determine available treatment options for patients using cross-functional analysis
Author/approve MRB Executive Summary with treatment options and meeting minutes as needed
Own and manage MRB outputs, action items, and Quality records
Record and manage MRB action items and approve MRB Record actions in electronic systems
Own and manage MRB and material conversion business processes, ensuring compliance with BMS Policies, Guidelines, Directives, site, and global procedures/specifications
Provide support to the MRB Coordinator in execution of Material Conversion activities

Skills

cGMP

QA Disposition

Material Review Board

Cell Therapy

Manufacturing

GMP Compliance

Deviation Management

Stakeholder Coordination

Non-conforming Material

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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