Senior Manager, MSAT Compliance and Investigations at Bristol-Myers Squibb

Bothell, Washington, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Highly adept in cross-functional collaboration and leading and coaching teams through difficult conversations with cross-functional teams
Strong ability to lead others and mentor to accelerate career growth
Confidence in leading initiatives of limited scope, mid to high level initiatives, and teams (evidenced by measurable tactical/strategic achievements and 360 feedback)
Ability to work with minimal supervision on multiple projects, contribute to complex projects, and occasionally lead complex technical and cross-functional teams
Expertise in root cause analysis, investigation processes, and advanced techniques for complex events
Proficiency in managing quality records, KPIs, and stakeholder relationships (e.g., with Quality Assurance, CTTO, Manufacturing, Quality Control, Product Sciences, cross-site counterparts)

Responsibilities

Manage a team of BMS FTEs and contractors providing direct support to enable successful and efficient manufacturing operations for personalized cell therapy products (clinical trials and commercial supply)
Oversee investigational function of the MSAT Compliance and Investigations (C&I) team, including product/process impacting root cause analysis, investigation, and assessment activities
Develop and enable technical excellence and advanced root cause analysis techniques to ensure thorough investigations into complex events
Ensure completion of all deliverables, actively remove team barriers for execution, and develop long-term strategies to improve efficiency
Assist direct reports and team members with prioritization, communication of priorities, escalation to leadership, and enabling agility for high-priority events
Identify and implement effective KPIs to drive engagement and performance
Work with team members to identify barriers to execution, identify solutions, and execute or escalate for resolution/recommendation
Drive design and implementation of efficiency and quality improvements to locally owned programs and procedures; explore new tools, use creative problem solving (e.g., risk-based approaches), research, create proofs of concept, and introduce new technical/business practices
Lead multiple projects within investigation support area, contribute to broader site projects/initiatives, and occasionally lead complex technical/cross-functional teams
Enforce and master team processes, support understanding of benefits/tradeoffs, and frequently challenge/improve processes

Skills

Root Cause Analysis

Investigations

MSAT

Cell Therapy

Manufacturing

Quality Assurance

Compliance

Process Assessment

Team Management

Stakeholder Management

Quality Records

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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