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:
- The Director, Global Quality Systems, GMP Training and Documentation is responsible for Global GMP Training and Documentation Systems and processes.
- This position provides strategic system and regulatory expertise to the development, deployment, and maintenance of GMP Documentation System and Training processes, content, and programs.
- This position has accountability for decisions impacting GMP Documentation and Training System compliance.
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
- Responsible for Celgene Global GMP Training and Documentation Systems; Accountable for ensuring systems are compliant to applicable health authority regulations and consistent with industry best practices.
- GMP Global Training System/Process: Accountable for development, implementation and effective deployment of global GMP training processes and associated documentation including appropriate GMP policy statements, global standards, standard operating procedures and work practices. Support global and functional stakeholders in implementation of GMP training processes. Oversee management of GMP training related documentation.
- Training Content and Curricula Development: Oversee the design, development and deployment and delivery of effective training content utilizing available e-learning tools where appropriate. Lead Global training initiatives.
- Training for Departments Operating under GMPs: Plan, organize, implement and control the elements of the training system (including developing courses, curriculums, train-the-trainer programs, and delivering training) to support all personnel involved with GMP activities in supported operational departments in being prepared to do their jobs in compliance with applicable GMP Health Authority regulations and Celgene policies and procedures.
- LMS and Electronic Content Management Governance: Interact with functions responsible for corporate training and electronic content management, provide strategic direction and leadership to corporate-level initiatives related to training and electronic content, systems, and processes. Represent Technical Operations training and electronic content needs across the broader organization.
- Affiliates and Departments: Provide direction to enable leveraging training and documentation systems and processes for affiliate or departmental use. Provide strategic vision and expertise to assist with the development of training materials, curriculums, train-the-trainer programs, electronic content management strategy, etc.
- Electronic Training and Documentation System Ownership: Oversee GMP Business Process/System Ownership for the learning management system and documentation management system. Provide strategic direction and management support of global documentation and training business process/system owners. Ensure definition of IT system requirements needed to support the Celgene strategic vision for GMP training and documentation.
- Oversee and provide management support of departmental business process owners of global electronic and physical record management processes.
- Communication: Maintains effective oral and written communications, and provide advice related to metrics, content, systems, and processes to Celgene executive stakeholders, and stakeholders in other functions. Interprets the implications of global regulatory requirements, guidelines, trends, and standards on the documentation system and training function.
- Supports internal audits and Health Authority inspections. May represent Celgene’s documentation system and training function with industry associations.
- Human Resources: Leads the GMP Documentation and Training Function, with demonstrated ability to effectively delegate and lead others. Coaches and develops direct reports, and mentors other colleagues within and outside of Global Quality Operations Systems. Ensures cross-training of direct reports on systems outside of training, and of others on training systems, as needed to support business objectives. Provides supporting back-up coverage for other Global Quality Systems areas, as needed.
4. EDUCATION AND EXPERIENCE
Relevant college or university degree required; advanced degree preferred.
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.