Category: Scientific & Clinical
Title: Quality Administration Manager
Directly report to: Director of Quality Assurance & Compliance
SUMMARY OF RELEVANT JOB RESPONSIBILITIES:
Quality Administrator responsibilities includes but is not limited to the following:
- Lead and support the life cycle management of COMPANY’s global SOPs, collaborates with counterpart in Shanghai and subject matter experts; issues the new or updated SOPs appropriately to relevant department/functional groups; maintain SOP index and core curriculum.
- Lead the efforts to develop, document and drive the activities around creating and managing the SOPs associated with our customer s external regulatory, internal business and IT systems use operations.
- Support the maintenance of training compliance and training documentation for each functional group.
MAJOR RESPONSIBILITIES AND DUTIES
The duties and responsibilities of the Quality Administrator responsibilities include but are not limited to:
- Support the life cycle management of COMPANY’s global SOPs and collaborates with life cycle management with regional SOP administrators. Drive day to day activities to ensure operational SOPs are effectively managed and maintained from a governance and on-going operations perspective.
- Responsible for a variety of tasks which include the creation and maintenance of all customer SOPs. Supports the identification of the SOPs that should be updated based on life cycle management schedule, updated ICH-GCP and local health authority regulations and laws, updates to company practices based on Health Authority inspection outcome or CAPAs, and organization structural updates.
- Lead SOP working groups to review and update process. Collaborate with Quality Administration Manger in Shanghai with the assigned functional subject matter experts from both offices.
- Update and maintain SOP Index/Table of contents to ensure it is always current and accurate.
- Issue of new SOPs to relevant department/functions.
- Assign new employees the core SOP curriculum based on the hiring department, collaboration with the hiring manager, and expected job description.
- Supports the maintenance of training materials within the training management system.
- Supports the maintenance of core SOP curriculum working with each Department/Functional heads and in the training management system.
- Be the primary point on contact for all SOP processes, maintenance and enhancement of a AnyShare based SOP repository and approval system (in collaboration with assigned IT personnel).
- Collaborate with Quality Administration Manager in Shanghai to ensure there is continual alignment of the core SOP curriculum periodically as assigned by the Director of Quality Assurance & Compliance.
- Semi Annual Training compliance check – collaborating with the department/functional head to ensure that the semiannual training compliance check has been completed and conducting 10% compliance review of select department/functional group for inspection readiness.
- Be the primary point on contact for all training processes, maintenance and enhancement of a WordPress based Training System for training documentation repository and approval system (in collaboration with assigned IT personnel).
- Support the training documentation filing for each department/functional group.
- Lead and support process improvement initiative including tools and technologies relevant to Quality Management Systems.
- Support teams clarify SOPs or regulations to ensure compliance.
- Support teams with compliance to ensure inspection readiness at all times.
- Bachelor's degree (required) or higher (desired) in scientific, medical or related discipline
- Minimum of 8 years of experience working in execution and/or oversight of clinical trials and GxP quality (required).
- Previous experience managing SOPs, SOP development and updates, SOP writing and conduct SOP training upon release to appropriate audiences.
- Previous experience or advanced understanding of fundamentals of clinical trial conduct & management and ICH-GC, FDA regulations and EU clinical trial directives (preferred)
- Must have the ability to interpret global regulatory standards.
- Ability to plan and organize work in an efficient manner and work well under time constraints.
- Broad knowledge of management of standard operating procedures, good documentation practices, and records management.
- Strong oral and written communication skills as well as the ability to apply a detailed, clear and analytical approach to solve problems and complete unfamiliar tasks.
- Demonstrates leadership and provides proactive, collaborative support to cross-functional peers. A team player with influencing and negotiation skills.
- Inspection support experience (FDA, EMA and other inspectorates) preferred.
- Experience in company start-up environment preferred.
- Flexibility to respond to changing business needs.
- Must have experience setting up electronic tools and training management systems.