Job Type: Regular
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
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
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
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