Celgene Senior Manager, Global Quality Systems in Summit, New Jersey

Description

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.

PURPOSE AND SCOPE OF POSITION:

This position is responsible for management of key systems as Oracle Quality Lead and GMP

Clearance administrator. The position has accountability for decisions regarding applicable system

compliance including design, implementation and continuous improvement and is responsible for

development of applicable processes and procedures.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

 Must have expert GMP, Quality, and in-depth risk management knowledge;

 Must be able to interpret problems and effectively prepare surrounding communication

in a productive manner to management and the group with clarity, brevity, and

accuracy;

 Must be able to recognize and group technical/scientific attributes and drive science based

decisions in most technical areas and to a deeper level in the specific job function;

 Must drive development of technical or scientific initiatives by interdisciplinary teams;

 Must have strong authorship and be able to critically review investigations, interpret

results, and generate technical conclusions consistent with Quality risk management

principles;

 Must be able to recognize patterns and trends in reported data and communicate strategic

solutions to stakeholders cross-functionally;

 Must be skilled in planning and organizing, conflict management, coaching others, talent selection,

developing others, decision-making, building relationships, innovation management, and resource

allocation. Must possess authenticity;

 Extensive experience with design, implementation and continuous improvement of electronic

technology solutions;

 Strong computer skills with knowledge of common business software platforms;

DUTIES AND RESPONSIBILITIES

Global Quality Business Lead for Oracle ERP

 Work with Global Process and Technology to ensure continuous improvement of the

technology solution through periodic enhancements and upgrades of Oracle and related quality

boundary systems.

 Collaborate with site subject matter experts and cross functional Quality and Technical

Operations to ensure new and emerging Oracle process, functionality and data needs are

identified, prioritized and planned for on the ERP Technology Roadmap.

 Collaborate with Oracle site and functional leads and Global GMP Training to ensure robust

Oracle training programs and curricula for GMP processes; Working with Process and

Technology personnel, maintain Oracle Role Mapping

 Liaise with internal Global Process Technology, Celgene IT and external system vendors on

topics related to system performance, security access, upgrades and planning

 Review and approve change controls for Oracle EBS (QA Business Owner). Coordinate review

with site Quality stakeholders where applicable. Communicate and coordinate system changes

to Quality Globally

 Review and approve applicable Global deviations related to Oracle EBS. Facilitate

communications among impacted stakeholders and site Quality business units to ensure

adequate communication, impact assessment, risk assessment, and documentation of

resolution.

 Ensure applicable quality related global SOPs and work practices are created and maintained

(global ownership). Provide Quality approval of Global Oracle related SOPs and Work

Practices

 Facilitate identification and implementation of best quality and compliance practices related to

Oracle across multiple sites

 Facilitate communications and activities related to issue identification and resolution

 Provide Quality process and systems support to all Quality functions within Global Technical

Operations. Act as Oracle Quality Business contact during audits/regulatory inspections of the

system

Business Process Owner for the GMP Clearance program

 Owner of the GMP Clearance database

 Assure GMP Clearance documentation is provided to appropriate requestors

 Provide notarization/apostille service for clearance documents provided to regulatory agencies

 Develop, implement and maintain GMP Clearance SOPs

Develops, implements and maintains processes and procedures related to job function. Assures

processes and procedures are compliant with relevant GMPs. Ensures continuous improvement of

governing processes and technology solutions through periodic enhancements and upgrades.

Communicates effectively with all cross functional and regional stakeholders on matters related to

job responsibilities

Provides back-up support for QA oversight of IT Enterprise systems

Provides support during internal and health authority inspections of facilities and CSPs

Performs other assignments as required

EDUCATION AND EXPERIENCE

 Relevant college or university degree.

 7-10 years relevant work experience; minimum 5 years of project or people leadership

experience; equivalent combination of education and experience acceptable.

 An equivalent combination of education and experience may substitute.

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.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.