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 global electronic and physical record GMP/GDP documentation systems and associated business processes. This position has accountability for decisions affecting documentation system compliance including design, implementation and continuous improvement of electronic document management systems, and development of global document management processes and procedures.
DUTIES AND RESPONSIBILITIES:
Business process owner for GMP/GDP electronic documentation management system. Develop and implement processes and systems for electronic document management and assure consistent deployment throughout the organization;
Responsible and accountable for the development, deployment and implementation of effective and efficient procedures and work practices governing the global electronic documentation system;
Effectively monitor electronic documentation system at the global level and ensures continuous improvement;
Accountable for development and provision of effective electronic documentation system KPIs, metrics, management review, and proactive issue identification and resolution;
Facilitate identification and implementation of best demonstrated quality and compliance electronic documentation system practices across multiple manufacturing and testing sites;
Establishes electronic documentation system standards and ensures that documentation complies with standards;
Provides support during internal and health authority inspections of facilities and CSPs;
Manages electronic document change control systems at the global level;
Responsible for development of system for archival of electronic records;
Ensures the documentation system is scalable and flexible to support acquisitions, new product launches, product in-license operations and new market opportunities, and other initiatives;
Communicates effectively with all cross functional and regional stakeholders on matters related to the electronic documentation system;
Responsible for managing record retention policies and procedures;
Provides leadership through execution of the electronic documentation system related Quality Systems Objectives;
Oversees management and maintenance of the GMP Document Room in Summit, New Jersey;
Directs human resources including establishing staffing needs, interviewing and selection, organizational development, training, managing resources, mentoring, coaching and counseling and the performance management and compensation processes;
Establishes and oversees the department's budget and analyzes and recommends capital expenditures for technology and equipment;
Reviews and approves all new and revised function SOPs to ensure compliance with cGMPs.
Leads the electronic document management governance process, the change advisory board (CAB).
Interfaces with IT delivery and project management as the Business Lead. Develops and prioritizes system enhancements and added functionality based on business need and prepares associated documentation to secure capital funding.
Ensures capital projects are delivered within timeline and budget*LI-KM1
EDUCATION AND EXPERIENCE
Bachelor's degree required; Advanced degree preferred. 10 years' experience in the pharmaceutical industry.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
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, management and continuous improvement of electronic and physical record document management systems and practices;
Demonstrated proficiency with PC-based office computers and standard Microsoft Office applications;
Demonstrated ability to maintain current knowledge of applicable regulations and other regulatory changes.
Supports the communication of Quality goals and strategy to global Quality teams.
Leads and plays a key role in multi-disciplinary / global teams.
Ability to resolves Global issues. Demonstrates in depth innovative thinking.
Expert authorship of controlled documentation. Able to critically interpret results and determine the desirability of new or additional content for GMP policies and standards, etc.
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.