Molecule Quality Lead

Posted 28 days ago
Main Location
New York City, NY, United States
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At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Summary:

Key responsibilities of the Associate Director, Molecule Quality include: 1) Design and implement  end-to-end quality strategy for assigned Molecule; 2) Ensure successful Health Authority (HA) engagement; 3) Manage for cause, critical and/or complex quality issues as well as serious breaches for the assigned molecule; 4) Engage in appropriate activities to support product submissions; 5)Establish strong partnership with business stakeholder.

Responsibilities:

  • Design and implement the quality strategy for the molecule 
    • Assess specific risk areas - brings ideas and strategies to the forefront and propose modifications to the Quality Assurance Program where necessary
    • Identify and drive continuous quality process improvements as a consequences of audits, assessments, inspections, trends/metrics and root cause analysis
    • Lead implementation of Quality by Design principles for the molecule
    • Develop, implements and maintain the molecule quality plan summarizing the quality strategy by summarizing the result of evidence of quality activities
    • Integrate end –to end quality principles and review project milestones with R&ED/GDD
  • Establish strong partnership with business stakeholder
    • Seek to understand and evaluate their priorities
    • Actively participate in and make meaningful contributions
    • Deliver independent expert support and propose solutions
    • Present key data (compliance, conformance, issues and risks) to drive decision making
  • Manage for cause, critical and/or complex quality issues as well as serious breaches for the assigned molecule
  • Engage in appropriate activities to support product submissions
  • Ensure successful Health Authority engagement
    • Demonstrate implementation of quality strategy to Health Authorities
    • Create quality plan to be shared with Health Authorities
    • Prepare for inspections and support inspections
  • Provide guidance and training on relevant GxP regulations and guidelines to cross-functional business partners.

Degree/Certification/Licensure

  • B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training and experience

Experience – Responsibility and minimum number of years

  • Mnimum 8 years QA experience or relevant experience in medical quality management, biomedical science, clinical development, or regulatory compliance

Competencies – knowledge, skills, abilities, other

  • Demonstrated strong knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance
  • Understanding of BMS’s therapeutic areas (Oncology, Cardiovascular, Hematology, Cell Therapy and Immunology and Fibrosis)
  • Demonstrated applied knowledge of clinical/pharmacovigilance and regulatory requirements, as well as analytical, organizational and planning skills
  • Broad knowledge of applied risk-management including risk assessment, risk analysis, risk evaluation, risk reporting and communication, risk treatment and the review of continuous risk management
  • Experience in regulatory inspection preparation, management, and related follow-up
  • Proven problem-solving skills to prevent and overcome complex process and quality related issues during clinical program implementation and execution
  • Proficiency in utilizing data to generate insight and to formulate clear business questions that can be answered with data
  • Communication Skills:  Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers; excellent presentation skills for compelling peer and Senior Management communication
  • Project Management: Must be able to manage projects and  deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines
  • Responds resourcefully to changing business conditions and opportunities, proactively looking for ways the organization can adapt its plans, tactics, or strategies

Software that must be used independently and without assistance (e.g., Microsoft Suite)

  • Microsoft Suite, Veeva Vault QMS, SharePoint, other systems as assigned/applicable

BMSBL

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

Mission
We're a community of women leveraging our connections into top companies to help underrepresented women get the roles they've always deserved. Simultaneously, we work to build truly inclusive hiring processes and environments where women can thrive and not just survive.
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Molecule Quality Lead
Bristol Myers Squibb