Manager, Quality Assurance Shop Floor, Cell Therapy at Bristol-Myers Squibb

Devens, Massachusetts, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Experience in Quality Assurance Shop Floor support within cell therapy or similar GMP environments
Knowledge of Bristol Myers Squibb (BMS) policies, standards, procedures, and Global cGMPs
Skills in effective communication, critical thinking, and continuous learning
Ability to handle internal compliance and documentation tasks
Capability to monitor and track process performance using data and analytics
Availability for Monday to Friday standard working hours

Responsibilities

Accountable for the performance/delivery of the QASF quality organization, including oversight of “QA on-the-floor” systems and programs to ensure highest quality and quickest delivery of QA cGMP tasks
Develop, implement, and continuously improve standard procedures and training for team-members related to quality systems
Proactively identify and address quality risks and critical issues, drive mitigations with Quality Assurance staff and cross-functional partners, and escalate to senior management as needed
Lead and/or represent QA in leadership, staff and tier meetings, governance forums, or on project teams
Act as a QASF subject matter expert on behalf of the facility during audits and inspections
Provide timely QASF support to site compliance activities
Serve as local process owner for core QASF systems/processes including Alarm Review, Batch Record Review, and GMP Walkthrough Program
Steward standard operating procedures, training, and manage relationships with key stakeholders
Monitor and track process performance related to key Shop Floor quality assurance tasks and operational tasks through data and analytics
Own, review, or approve Floor Quality GxP records including procedures, CAPAs, change controls, impact assessments, documentation, or deviations
Represent QASF at relevant governance forums
Flex to support ad-hoc deviation approval or batch record review as requested by management

Skills

Key technologies and capabilities for this role

Quality AssurancecGMPCell TherapyShop Floor ManagementComplianceDocumentationMetrics MonitoringManufacturing Oversight

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 personal lives.

Is this a remote position or does it require on-site work?

This information is not specified in the job description.

What key skills are needed for the Manager, Quality Assurance Shop Floor role?

Key skills include effective communication, critical thinking, and a thirst for knowledge, along with experience in quality assurance processes like Alarm Review, Batch Record Review, GMP Walkthroughs, data analytics, and handling GxP records.

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 this QA Shop Floor Manager position?

Strong candidates will have expertise as a local process owner for core QASF systems like Alarm Review, Batch Record Review, and GMP Walkthroughs, with skills in monitoring processes via data analytics, managing SOPs and training, and strong stakeholder relationships.

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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