Total 1 Manager level Quality Assurance / Control job vacancies in CHN - HA - Zhengzhou

The Manager, Medical Quality Governance (MQG) China, manages efforts and activities needed to enable and sustain Quality and Inspection Readiness across category team within scope of Pfizer’s Medical Quality Management System, for the China Region (including Hong Kong & Macau).

MAIN REPONSIBILITIES / DUTIES

Quality Management Under the oversight of the MQG Lead, China,

• Drive the Medical Quality program and strategies and overall culture of Quality within China Region
• Lead MQG risk assessment activities and provide strategic input for the MQG Strategic and Quality Plans.
• Ensure the development and maintenance of the Country Quality Plans.
• Design and implement MQG risk mitigation strategies in collaboration with relevant stakeholders.
• Monitor and drive quality performance for the China Region.
• Provide quality consultancy to the colleagues in the China Region, demonstrating knowledge and understanding of the individual markets.

Audits and Inspections

• In collaboration with the China MQG Lead and Country Medical Directors/ leads, manage PCO Medical Inspection Readiness, including Communication, Documentation,
• Training, Quality and Inspection Readiness Plan, Process and Risk Controls.
• Monitor the country audit/inspection outcomes, share learnings, flag areas of concern to China MQG Lead/Country Medical Directors/leads.
• Understand Audit/Inspection trends and ensure timely action.
• Enable compliance to QMS07 and QMS13 requirements by promoting the use of the professional record repositories and contributing to PCO medical training curricula maintenance.
• Provide support for regional/country audits and inspections, as needed.

CAPA Management and Execution

• Act as the local technical expert on QMS01 and provide guidance to local colleagues when necessary.
• Ensure effective management of quality events (QEs) and Corrective and Preventive Actions (CAPAs) for China, as per Pfizer requirements.
• Continuously monitor QE and CAPA performance within China.
• Upon identification of risk or potential quality events, escalate as per Pfizer standards.
• Act as Quality Representative for the QEs within China.
• Conduct root cause analysis in consultation with local stakeholders and as per Pfizer requirements to identify effective CAPAs.
• Ensure effective implementation of CAPAs by local stakeholders.

SOPs and Other Procedures

• Partner with the China MQG Lead to drive implementation of policies and procedures in scope of MQG in China.
• Secure that proper control and oversight are in place to ensure compliance of country Medical controlled documents.
• Training.
• Support the China MQG Lead to ensure consistent training and communication plans for China.
• Facilitate country training compliance.

Other

• Lead and/or support global/regional quality related projects.
• Promote culture of quality across medical team and Platform Lines, where appropriate.
• Interact with internal and external networks.
• Demonstrate value proposition of MQG to internal and external stakeholders.
• Ensure appropriate information and communication management within China under the oversight of China MQG Lead.

REQUIRED SKILLS

Education & Experience

• Scientific or technical degree is mandatory e.g. Bachelor of Science/Pharmacy; Medical Degree, Masters Degree would be preferred.
• Preferably over 2-5 years’ experience.

• Experience in medical affairs preferred; experience in regulatory/ pharmacovigilance/ medical information/ clinical research acceptable; experience managing stakeholders from commercial/ marketing will be valued
• Supervisory experience in a matrixed organization is valued.
• Experience in managing multiple complex projects is valued.

Technical/Functional Competencies:

• Excellent command of Cantonese and English.
• Experience in navigating a large, complex matrix organization and managing stakeholders’ interests.
• Strong project management skills.
• Experience in developing and executing training at all levels of the organization.
• Excellent analytical skills with a demonstrated ability in risk identification, measurement and assessment, risk monitoring, reporting and escalation.
• Ability to work in a fast-paced and demanding environment.
• Strong organization and planning skills.
• Ability to communicate well within all levels of Pfizer with high level of influence and impact skills.
• Senior management engagement and communication skills.
• Ability to travel as required.

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Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.