Associate Director QC Network Leader - Global Product Quality

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Job Summary

Bristol-Myers Squibb is seeking an Associate Director, QC Network Leader within the Global Product Quality, Cell Therapy organization. The ideal candidate will be an experienced Quality professional with prior experience in managing clinical and commercial QC laboratories. As the QC network lead, the candidate will lead and direct the harmonization efforts of platforms, strategies, technologies, global policies and procedures across numerous clinical and commercial sites across the cell therapy network. Working with the individual QC site heads, the candidate will lead the QC network to drive efficiencies, improvements, risk mitigations, and alignment on common practices and strategies in support of routine GMP testing activities supporting both release and stability testing activities. The candidate will be a matrix leader to support QC alignment across sites in Washington, New Jersey, and other future sites within the cell therapy network. The candidate will serve as a change agent / influencer to drive implementation of new technologies developed in support of process and analytical improvements (including platform strategies, automation improvements, etc.) in support of global product teams and site Quality teams. The primary responsibility will be to improve the maturity of the Quality QC network (practices, procedures, technologies, etc.) and programs owned by Global Product Quality within the cell therapy development organization. The candidate should drive alignment across cell therapy programs relating to system improvements, common practices, and develop common strategies, practices, workflows, and implementation practices.

The candidate will provide significant support and contributions to the Cell Therapy Product Quality Teams by developing cross-program / cross-site QC network strategies based in industry best practices, health authority guidance documents and/or feedback, and standardized KPI metrics. The Associate Director, QC Network Leader a part of the Global Product Quality leadership team and should utilize their leadership and technical skills to shape and drive global initiatives relating to cell therapy, gene delivery, QC strategies, contract test lab oversight to provide significant contribution to the daily operations of the Global Product Quality organization. The position will be responsible for ensuring compliance with the current and prospective global regulatory requirements and should be aware of and adopt effective and efficient industry standard practices.

REQUIRED COMPETENCIES; Knowledge, Skills and Abilities

Must have a strong Quality Control mind-set with extensive knowledge and experience of cGMP operations as well as general industry (ICH, USP, etc.) and health authority (FDA, EMA, PMDA, etc.) requirements for cell-therapy programs.

Must be a change agent to drive harmonization across multiple QC sites / organizations to align on a common strategy to improve efficiency, align on technology platforms and reporting metrics, and establish best practices to roll out across the global QC network.

Knowledge of risk management principles and their implementation into routine production and/or testing strategies.

Must be able to interpret problems and effectively communicate in a productive manner to management and teams.

Must be able to evaluate technical/scientific attributes and drive compliant technical decisions under minimal supervision. Experience with automation and implementation across multiple sites is also desired.

Must have strong troubleshooting skills and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality requirements.

Strong technical writing skills.

Must manage problems of diverse scope and demonstrated ability to translate complex issues in a concise manner.

Must be able to effectively operate and deliver in a continuously evolving regulatory and operations landscape.

Must proactively align numerous legacy cell therapy sites to ensure alignment and serve as a change agent for the sites, to drive common accountability as the organization expands its global footprint and moves from a clinical to commercial operation.

DUTIES and RESPONSIBILITIES

Leads a matrix QC network to support global cell therapy QC operations and drive efficiencies and improvements as needed.

Collaborate within individual site QC teams, Global Product Quality, and individual functions (i.e. analytical development) to generate, review and approve strategies for improvement and implementation of best practices and automation.

Develops, implements and continuously improves global QC Operations processes pertaining to quality oversight of QC testing laboratories, ensuring quality related items are tracked, monitored and resolved in a timely manner.

Oversee and perform cross-functional QC laboratory assessments and implement improvements to assure global alignment and improvements.

Performs document management responsibilities in support of global QC network as needed. May own policies and procedures as needed across global QC network.

Develops, monitors and reports on Network QC activities, establishes Key Performance Indicators, and creation of dashboards and provides updates to management/leadership teams.

Identifies global QC network issues and effectively and proactively communicates and resolves them in a diplomatic, flexible, and constructive manner.

EDUCATION and EXPERIENCE

Bachelors’ and/or Masters’ degree in scientific discipline with a technical understanding of biopharmaceutical production and understanding of cell therapy and drug product development and manufacturing

Minimum of 10 years of biologics industry experience in a technical role(s) supporting programs in pre-clinical phases through commercial, with at least one or more role (5 years) in Quality (QA, QC and/or Compliance)

Strong project management skills and ability to communicate effectively across matrix functions

Strong knowledge of global regulations (EU, US) and GxP experience

Excellent verbal and written communication skills

Ability to prioritize and balance work from multiple projects in parallel

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com