Manager Quality Systems, Investigations and CAPA 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

Pharmaceuticals, Biotechnology, Cell TherapyIndustries

Requirements

Ability to research, understand, interpret, and apply internal policies and regulatory guidelines
Proficient computer skills with knowledge of several digital tools like MS Office, etc., and ability to learn and work with new software applications
Ability to interpret data & results, understand complex problems with multiple variables and critically assess and provide feedback on impact assessments and proposed change control actions
Ability to critically review reports, interpret results and assess and challenge technical conclusions consistent with quality risk management principles
Excellent verbal and technical writing skills with ability to prepare written communications and present technical data to management with clarity and accuracy
Ability to work in a fast-paced team environment and changing priorities
Detail oriented and task focused with ability to meet deadlines and prioritize work
Able to independently work across teams

Responsibilities

Review and approve complex site quality system deliverables and risk assessments associated with all aspects of manufacturing process including incoming, manufacturing, laboratory, facility, and utility systems
Ensure quality system deliverables are robust and adequately address requirements and risks, by providing oversight and rubric reviews, as applicable
Support the administration and maintenance of quality systems such as CAPA, Investigations, including metrics reporting and analysis, stakeholder communication, and governance meeting facilitation, as needed
Share data/knowledge within and across site and network. Build & maintain strong relationships with partner functions
Lead meetings and represent function at cross functional and network meetings
Identify improvement opportunities and drive team continuous improvement goals and projects
Support internal and external inspections
May act as subject matter expert and present quality system program overviews and related topics during audits
Maintain compliance with assigned learning plan
Support integration of newer team members and provide guidance and coaching to users of the electronic QMS, CAPA, and Investigations quality systems, as required

Skills

CAPA

Investigations

Quality Systems

Risk Assessments

Metrics Reporting

Process Performance

Continuous Improvement

Governance

Manufacturing Processes

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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