Pfizer Medical Quality & Oversight Manager in Beijing, China
Medical Quality & Oversight Manager
The Medical Quality & Oversight Manager (MQOM) works in Medical Quality Oversight team in supporting the Medical Quality & Oversight Director to work closely with in-country platform lines to promote the quality management, compliance, inspection readiness, training process improvement, and the oversight needed, to ensure the high quality performance of country medical operations.
KEY RESULT AREAS & JOB ACTIVITIES /TASKS
1) Medical-compliance related training
Be responsible for development of strategic plan for China Medical Affairs and communicate with MALT for training Plan
Be responsible for Job role and training curricular assignment
• Process the 'LARS' on Power-2-Learn (P2L) for job role, local WIs and specific training curricular assignment, based on the confirmation from supervisor.
• Generate quarterly tracking form and confirm with relevant team leaders for the job role and training courses assignment.
• Ensure medical staff and targeted colleagues are assigned with appropriate job role(s), local WIs and training curriculum by P2L system and assure that the processes described in the SOP ADM02 and China WIs are followed.
- Be responsible for tracking compliance of medical related trainings
• Run P2L BO report at least monthly to check the training completion and ensure medical staff to archive the full compliance for P2L required trainings.
• Track the unmet requirement report monthly. If required training is not completed by the due date, conduct the follow-up and document the relevant records.
• Generate kinds of training analysis reports to give input for the medical related trainings and track training compliance as appropriate.
Be responsible for developing and update training plan and materials for the orientation and medical related training for new comers
Be responsible for providing the orientation and medical related training for new comers
• Disseminate instruction email to medical new comers, maintain the 'new hire instruction' document current and accurate with corporate policy, SOP and WI.
• Provide the orientation training and relevant documents for new comers of medical and medical partner team.
• Present the medical related trainings including the training of good documentation practices for the new comers of medical partner team.
- Be responsible for documentation management of medical-compliance related training
• Provide the support to conduct the medical-compliance related trainings.
• Manage the training documentation and maintain the training tracking form and folders.
- Be responsible for submitting analysis report about training compliance to MALT
2) Procedures Improvement
Be responsible for Local CMCD assessment compliance
Be responsible for administering local SOP, Working instruction (WI)/Local Working Practice (LWP) and ensure the required documents are appropriately documented according to SOP QMS04.
Be responsible for develop strategic plan for Audit/Inspection Readiness
Support on the audit/inspection activities carried out by QA group/regulatory authority
• Distribute upcoming audit/inspection information locally as appropriate and maintain audit/inspection tracking form and management folder.
• Provide the support on the coordination with audits/inspection organized by audit/inspection groups (e.g. serve as point of contact ("Coordinator") between PCO and audit/inspection groups, audit scheduling/ logistics, report distribution, communication of local processes, updates, communication of final results and follow-up the audit/inspection CAPAs)
Be responsible for uploading the key inspection readiness documents (CVs, JDs, Org Charts and training documentation) of PCO Medical Department into the SharePoint site and ensure the most up-to-date version and correct documents are available in the Repository.
Conduct the quality review and distribute the quality report for CVs, JDs, Org Charts and training documentation of medical staff at least twice per year and ensure the documents in full compliance with compliance plan.
4) Team Specific Responsibilities
- The MQOM may be required for certain project/task as decided by MQO Director.
1. Educational /Training
- Education: Bachelor degree is required, Master degree is preferred
2. Working Experiences
At least 4 year professional experience in Medical/Regulatory/R&D Dep. in pharmaceutical industry demonstrating the following:
Thorough knowledge of ICH GCP and related local regulations
Understanding of the processes and regulatory requirements associated with clinical development, regulatory, medical and safety operations
A good sense of compliance to clinical guidelines, regulations and protocol
Experience with assisting SOP and training implementation
3. Ability Functional
Conscientious, good team player
Must be independent, pro-active, self-motivated with strong organizational, interpersonal and communication skills
Excellent follow-up skills
Excellent verbal and written communication skills for interaction with manager and colleagues
Proficient in both verbal and written Chinese and English
Demonstrated proficiency with all software including Outlook, Word, Excel, and PowerPoint as well as internet applications with ability to learn new applications
4. Cultural Competencies (Leader Behaviors)
Sustain Focus on Performance
Create an Inclusive Environment
Align Across Pfizer
N: Not Applicable - 不适用 (China)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.