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Manager, Data Integrity CAR T at (BMS) Bristol-Myers Squibb in Warren, New Jersey

Posted in General Business 30+ days ago.

This job brought to you by eQuest

Type: Full-Time





Job Description:

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.

PURPOSE AND SCOPE OF POSITION:

This position is responsible for implementing and managing Celgene’s GMP Data Governance and Data Integrity program at the Warren, NJ site for the CAR T development facility. This includes implementing documentation and processes in support of the laboratories, manufacturing and GMP support areas.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

·       Must have expert GMP, Quality, and Data Integrity knowledge;

·       Must be able to effectively interpret problems and communicate in an impactful manner to management and the group with clarity and a high level of accuracy;

·       Must be able to note data integrity attributes in potential situations or issues and process science based solutions across a majority of the job function;

·       Must provide guidance to other employees in the interpretation of data integrity issues; across the Summit and Warren, NJ sites;

·       Must be able to critically review reports while effectively inputting and expressing Data Integrity principles;

·         Completes routine tasks with no supervision; Confident in making decisions in their subject matter area; Able to work proactively. Drives continuous improvement and improves efficiency and productivity within the group or project;

·       Leads cross functional project teams driving performance and results. Skilled at getting resources and information from internal and external contacts;

·       Manages conflict and issues with internal and external customers. Able to recognize conflict and notify management with proposed recommendations for resolution;

·       Builds and leverages relationships and provides advice internally within function and with global cross-functional teams. Negotiates solutions cross functionally;

  • Recognizes data integrity risks, develops contingency plans, ensures remediation efforts are driven to completion;

  • Able to fully interpret complex data Integrity results and situations independently and articulate recommendations for resolution;

  • Must possess a strategic perspective, leading vision and values, and support Global harmonization efforts as part of a Global Data Governance and Data Integrity team;

DUTIES AND RESPONSIBILITIES:


  • As a key member of the Global Data Governance and Data Integrity Program contribute in the development, revision, review of Global policies, standards, and requirements

  • Ensure local site activities are harmonized with Global DG/DI efforts, and are driven to completion as planned

  • Provide feedback and support to GMP areas in scope during process development and improvement, while ensuring compliance with Global DG/DI policies and standards

  • Responsible for ensuring systems at the Warren, NJ CAR T facility comply with data life cycle requirements from initial data creation/recording to archival and decommissioning. This includes, but is not limited to, data management (e.g., data creation, data processing, review, reporting), data security, data traceability process mapping, data backup/restore, electronic signature/electronic record linking and data audit trails.

  • Responsible for leading, reviewing and approving data integrity assessments for the Warren, NJ CAR T facility of new and existing systems including, but not limited to, manufacturing and laboratory systems to ensure compliance with regulatory requirements and company established requirements for data integrity.

  • Responsible for leading, reviewing and approving data integrity periodic reviews and performing risk monitoring of implemented systems across all sites to ensure continued compliance.

  • Drive mitigation and remediation when data integrity gaps are identified.

  • Responsible for leading, reviewing and approving investigations and implementing corrective/preventative actions associated with data integrity events.

  • Responsible for ensuring data integrity processes for automated systems across all sites are designed to align with computerized system development life cycle (SDLC) methodologies to ensure computerized systems meet regulatory requirements, company requirements and align with industry standards. In this respect, this role is also responsible for assisting with strengthening and modernizing existing computerized SDLC methodologies to align with data integrity processes.

  • Identify and work with functions at Warren CAR T facility and across the CTDO Cell Therapy network to ensure data risk is identified, remediated and prevented.

  • Seek out and recommend to management opportunities for increased data integrity program efficiencies and operational improvement through modifications to current systems, implementation of new systems and more efficient use of established systems

  • Provide the GMP functions any updates regarding data integrity regulations that they may be impacted by.

  • Prepare and deliver communications to GMP functions leadership regarding risk, mitigations, data integrity metrics, and Global DG/DI Program planning

  • Represent the Warren, NJ Facility as the DI SME during corporate audits and/or regulatory inspections.

EDUCATION AND EXPERIENCE:

Bachelor’s degree preferred OR an equivalent combination of education and experience acceptable;

·      Minimum 6 years relevant work experience with at least 3 years focused in Data Integrity and a minimum 2 years of leadership or cross-functional leadership experience required;

      Regulatory Audit Experience is Highly Preferred.

·      Experience with PC based office computers and standard Microsoft Office applications;

·      Experience with SharePoint;

·      Experience with electronic document and data management systems

WORKING CONDITIONS: (US Only): ENVIRONMENTAL CONDITIONS: (US Only)

Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

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.