Bristol-Myers Squibb

Senior Director, QMS Lifecycle Management & Operational Controls

New Brunswick, New Jersey, United States

Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, BiotechnologyIndustries

Requirements

Candidates must possess a Bachelor's degree in Natural Science, Pharmacy, or a related field. A minimum of 15 years of experience in the biopharma/pharmaceutical industry is required, including at least ten years of people and team management and a minimum of 5 years of leadership experience in driving business transformations. A thorough understanding of GxP regulatory requirements, strong program/project management experience with a proven record of managing cross-functional programs, and the ability to oversee multiple projects are essential. Strategic thinking capability with the ability to make and act on decisions while balancing speed, quality, and risk is necessary, along with demonstrated influencing skills with senior levels over multiple disciplines, and excellent teamwork, interpersonal, and communication/listening skills.

Responsibilities

The Senior Director will develop and execute the strategic roadmap for Lifecycle Management and Operational Controls within the Quality Management System (QMS) to achieve long-term strategic goals. Key responsibilities include influencing and aligning QMS focus areas with senior leaders, ensuring the end-to-end flow of QMS processes, partnering with senior leaders to develop and execute a rolling 3-5 year strategy, and ensuring core competencies are built within the team. The role involves providing input to enhance process and the BMS Quality strategy, maintaining and prioritizing continuous improvement projects, identifying, mitigating, and communicating critical risks, and partnering with local sites to ensure document management capabilities and QMS compliance. Additionally, the Senior Director will develop and implement metrics, associated targets, and reporting mechanisms to monitor performance and champion a Quality mindset and Culture of Quality.

Skills

QMS Lifecycle Management
Operational Controls
Quality Management System (QMS)
Strategic Roadmap Development
Process Frameworks
Governance Controls
Research and Development
Commercial Operations
Cross-functional Collaboration
Stakeholder Management

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.

Land your dream remote job 3x faster with AI