Other Locations:US- NJ- Summit West
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 developing, implementing and managing Celgene’s Global GMP Data Governance and Data Integrity program. This position leads the GMP data governance program including Data Governance and Data Integrity policies, maintenance of Data Integrity document hierarchy content, development and maintenance of Data Integrity Standards and administration of global Data Integrity processes.
2. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- Must have expert GMP, Quality, and risk management knowledge that impacts the department or global function.
- Must be able to critically interpret problems and effectively communicate in an impactful manner to management, the group, and the broader organization with clarity and a high level of brevity and accuracy.
- Must be a technical/scientific expert. Must be able to measure technical/scientific attributes in qualitative ways and drive science based decisions across the organization.
- Must manage technical teams across the organization.
- Must have expert authorship of technical documents. Must be able to recognize the impact beyond a single project or collaboration.
- Must be skilled in strategic thinking, managing through systems, navigating politics, innovation management, and negotiation. Must possess a strategic perspective, leading vision and values, global acumen, and leadership disposition.
3. DUTIES AND RESPONSIBILITIES:
- Identify, develop and implement best demonstrated Data Governance and Data Integrity practices and systems across multiple sites:
- Develop and implement and maintain data governance and data integrity policies and standards,
- Develop and implement global processes and systems and associated global procedures;
- Work cross functionally to deploy throughout the organization;
- Ensure continuous improvement of Data Integrity program.
- Responsible for leading and executing a consistent, harmonized, sustainable and effective Data Governance and Data Integrity Program that complies with regulatory requirements and company established requirements.
- Responsible for ensuring systems across all sites 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 all sites 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.
- Responsible for defining, assembling and communicating data integrity metrics that yield on-going process improvements and optimization across all sites.
- Responsible for leading, reviewing and approving mitigation and remediation strategies across all sites when data integrity gaps are identified.
- Responsible for leading, reviewing and approving investigations across all sites 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.
- Responsible for performing continuous improvement of the Data Integrity Program ensuring the program is maintained current with industry standards and support key company initiatives.
- Maintains awareness of data integrity regulatory actions, current regulatory trends and their impact on existing systems and recommends internal process improvements.
- Provides leadership in interpreting regulations and guidelines associated with data integrity to ensure continued compliance of the Data Integrity Program.
- Seeks out and recommends 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.
4. EDUCATION AND EXPERIENCE:
- Bachelors of Science; Relevant college or university degree preferred. Equivalent combination of education and experience acceptable;
- 8-9 years of Pharmaceutical experience;
- 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):
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.
Celgene 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.