Sr. Manager, Data Integrity CAR-T
Other Locations:US- NJ- Warren
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.1. PURPOSE AND SCOPE OF POSITION:
This position is responsible for implementing and managing Celgene's GMP Data Governance and Data Integrity program at the Summit and Warren, NJ sites for the CAR T facilities (commercial and development). This includes implementing documentation and processes in support of the laboratories, manufacturing and GMP support areas.
2. 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;
3. 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 Summit and Warren, NJ CAR T facilities 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 across Summit and Warren, NJ CAR T facilities 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 Summit and Warren CAR T 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
4. EDUCATION AND EXPERIENCE:
- Relevant college or university degree preferred. Equivalent combination of education and experience acceptable;
- Bachelors of Science;
- Minimum 8 years relevant work experience and minimum 4 years of leadership experience; equivalent combination of education and experience acceptable.
- Experience with PC based office computers and standard Microsoft Office applications;
- Experience with SharePoint;
- Experience with electronic document and data management systems
5. 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.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
#LI-POSTCelgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.