Regional GCP Quality Lead (SH/BJ)

Job Description

locations China - Shanghai - Shanghai China - Beijing - Beijing time type Full time posted on Posted 30+ Days Ago job requisition id hidden_mobile ROLE SUMMARYThe regional GCP Quality Lead is responsible for driving a GCP quality culture at GBDM- SHANGHAI, CHN sites. The lead develops and implements the GCP quality culture programs, partnering with the global quality culture lead and fosters quality into projects through partnership with subject matter experts, functional quality leads, vendor quality lead within GBDM and Quality Centre of Excellence (QCoE). The regional quality lead instills the global GCP themes into the local programs, forums and communication to embed quality information throughout the systems, processes and projects for data quality throughout the site. The lead will be the GCP quality expert supporting India and Chennai and will be responsible to assess GCP quality and provide leadership, guidance and instruction for GBDM colleagues in handling GCP risks and issues.ROLE RESPONSIBILITIES GCP Quality Culture Programs
• Drives the development and implementation of GCP quality culture programs for the SHANGHAI, CHN sites, to improve the site s GCP maturity level, focusing on delivering sustainable quality information in an accessible format throughout the year
• Partners with process SMEs, the global QMS lead, and global quality culture leads to ensure local quality culture activities align with global deliverables.
• Partners with other quality groups lead and subject matter experts to ensure GCP quality
• Meets with quality governance stakeholders and members as needed (POB, RQA, QCoE, corporate compliance etc.) to gather input and feedback on the appropriate topics, deliverables, forums and timeframes for culture programs
• Ensures all GCP quality programs are delivered on-time and within the allocated budget.
GCP Expert / Regional Quality Lead
• Single point of accountability to the functional area stakeholders in SHANGHAI, CHN for GCP advice and guidance
• Provides GCP quality expertise to help monitor GCP quality and provide leadership, guidance and mitigation/remediation strategies for GCP quality risks and issues.
• Activities may include:
  • Partner with Functional Quality Lead and Vendor Quality Lead by providing regional support through internal and external assessments, implementation of global procedures for local needs
  • Partner with SHANGHAI, CHN functional line group leads to identify GCP quality culture focus areas of relevance within SHANGHAI, CHN or specifically impacting SHANGHAI, CHN in the global business model; recommend local or global programs to ensure GCP quality deliverables
  • Reviewing the global/SHANGHAI, CHN subset of quality performance for portfolio, vendor, and process in alignment with global activities (i.e. metrics review and signal detection mechanisms); recommending and implementing remediations as needed
  • Identify SHANGHAI, CHN specific Quality event and significant quality event and lead investigation activities in alignment with the global QE assessment and investigation group in QCoE
  • Partner with the QCoE Audit & Inspection Quality group to lead local audit/inspection preparation, coordination, and follow-up
  • Escalation on quality issues/risks to senior leaders in SHANGHAI, CHN and global groups such as CDSQ, QCoE and GBDM-LT
  • Leads improvement efforts, as needed, to remediate quality issues or mitigate risks
• Assess state of GCP quality via quality culture methodologies (e.g. culture survey, feedback, metrics) for the SHANGHAI, CHN sites
QUALIFICATIONS
• Demonstrated experience in clinical trial execution or clinical research quality, especially with data management, statistical programming & analysis and statistics functions and deep understanding of GCP
• Demonstrated development expertise, implementation experience and training design as well as strong project management experience required
• Significant experience within Pharmaceutical or healthcare industry
• Demonstrated experience engaging executive leaders and establishing stakeholder relationships
• Experience working in a regulated environment, developing quality and compliance programs is preferred
• Advanced business knowledge of Clinical Research & Development in a pharmaceutical environment
• At least 10 years of experience in managing multiple, highly complex projects
• Proven consultation and customer service skills
• A scientific or technical degree is preferred. Business degree and/or coursework are desirable. In general, candidates for this job would have the following levels of experience:
• BS 15 years or equivalent
• MS 10 years or equivalent
Work Location Assignment: On PremisePfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Quality Assurance and Control #LI-PFE,

Keyskills :
qualitycompliancecalibrationcoachingdeliverysubject matter expertsequal employment opportunitydata qualityquality centervendor qualitydata managementcustomer servicequality assuranceclinical researchproject managementbusiness knowledgelegi