Manager, Shop Floor Quality Assurance, Cell Therapy 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

Lead a team of 4-8 employees on the Shop Floor Quality Assurance team
Comprehensive understanding of Cell Therapy processes for real-time decision-making
Advanced ability to synthesize information from multiple sources, interpret problems, and communicate effectively to cross-functional management in a clear, brief, and accurate manner
Serve as a subject matter expert in the BMS quality management system, including deviation and CAPA action management, interim production controls, disposition decisions, and batch record management
Stationed in Devens, MA; reports to the Senior Manager, Field Quality Assurance for the Devens CTF
Shifts: 6am – 6pm, rotating schedule including holidays and weekends, onsite
Ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP

Responsibilities

Provide leadership to ensure routine on-the-floor Quality oversight and collaborative triages of unexpected events within Manufacturing, Quality Labs, and Supply Chain operational areas and systems
Respond to complex/critical issues and build consensus with subject-matter experts for product impact and justification to continue manufacturing
Provide direction and timely guidance to QA shift-managers regarding handling and resolution of cGMP events, deviations, batch record exceptions, and other quality operational issues
Accountable for the performance/delivery of the QA field quality organization, including oversight of “QA on-the-floor” systems and programs to enable highest quality and quickest delivery of QA cGMP tasks
Oversee and partner with operational teams to ensure compliance with applicable procedures and batch records
Provide real-time review of manufacturing batch record documentation and logbooks
Work with operations to resolve manufacturing issues
Develop and implement (incomplete in description)

Skills

cGMP

Quality Assurance

Cell Therapy

Manufacturing

Quality Control

Warehouse Operations

GMP Compliance

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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