Director, IT Quality Management, CSV Operations Clinical, Regulatory, Enterprise Information Management

Director, IT Quality Management, CSV Operations Clinical, Regulatory, Enterprise Information Management

Director, IT Quality Management, CSV Operations Clinical, Regulatory, Enterprise Information Management

Job Overview

Location
Princeton, New Jersey
Job Type
Full Time Job
Job ID
47704
Date Posted
3 months ago
Recruiter
Jobs For Everyone
Job Views
150

Job Description

Job Description

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.

Responsibilities:

  • Accountable for strategy and execution of Computer System Validation activities executed for portfolio of IT capabilities across all in scope functional areas to ensure 'fit for use' before release to production environment.
  • Responsible for the IT Data Integrity compliance program and operations to ensure enterprise systems are in alignment with internal expectations and relevant regulatory regulations related to Data Integrity.  
  • Partner with Enterprise Data Governance and Enterprise Architecture to ensure alignment of principles while identifying opportunities for improvement focusing on Data Management and Data Lake capabilities
  • Lead a team to execute CSV for IT Capability projects ensuring efficiency, consistency, quality of work and compliance with external regulations and internal procedures.
  • Lead programs with high risk and complexity and develop validation strategy for project execution.
  • Collaborate with IT Delivery leads, business users, and Global Quality function to ensure CSV projects are executed in accordance with internal procedures.
  • Ensure effective and efficient quality strategies for compliance and validations strategies are defined across all in scope areas and related technology solutions.
  • Applies understanding of key business drivers to accomplish team objectives and influence work across matrixed teams and ensures adherence to software development practices, compliance, and key IT controls.
  • Anticipates business and industry challenges and recommends best practices-based solutions to improve processes and systems
  • Identify and implement continuous improvement through enhanced technology solutions that improve digitization, compliance and productivity.

Qualifications:

  • Bachelors degree or equivalent, MBA/Masters degree preferred, in computer science, engineering, life science or related field.  
  • 10+ years of relevant experience.
  • Expertise in CSV, GAMP, Electronic Records/Electronic Signature regulations, and related health authority regulations and guidelines
  • Understanding of global pharmaceutical / BioPharma industry environments and competitive forces.
  • Demonstrated ability to lead in a highly matrixed organization. Ability to effectively build alignment and influence others in a matrix environment.
  • Strong leadership and supervisory skills
  • Decisive decision making capabilities.
  • Strong planning skills and demonstrated ability to influence and work across multi-discipline teams.
  • Ability to effectively communicate to a diverse audience at multiple levels across the organization.
  • Strong communication skills for effectiveness in meetings, presentations and in written form.
  • Knowledgeable in Software Development Lifecycle (SDLC) and demonstrated ability to execute and organize effectively across portfolio of IT capabilities and programs.

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. 

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.  Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.  This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Job ID: 47704

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