Director, Quality – QMS & Quality Event BPO

The Director, Quality – QMS & Quality Event BPO serves as the owner and key point of contact for the Research, Development and Medical Quality Event process (QMS01) at Pfizer. Additionally, this role supports Pfizer by monitoring the health of the RDM QMS and identifying cross functional areas of opportunity or risk to action and report to quality governance. This colleague also supports other QMS’ / QRCs (e.g. PGS) as applicable. Finally, this role is responsible for QMS oversight activities and including continuous improvement efforts.

What You Will Achieve

• QMS Ownership
  • QMS Business Process Ownership of QMS-01
  • In partnership with RQA Head, leads and supports the development and delivery of enhancements to the RDM QMS and coordinates communications regarding updates to the RDM QMS
  • Authors and co-ordinates periodic review of the RDM QMS Manual; serves as delegate of Enterprise Quality Policy
  • Leads root cause analysis of significant quality issues impacting more than one functional business area or impacting RQA
  • Engages in review and impact assessment of emerging regulations or inspection trends relating to QMS, partnering with functional QA groups in development of recommendations or feedback
  • Serves as Product Quality & Safety ESG lead; coordinates annual contribution to impact report / other regulatory expectations
• Governance
  • In support of RQA Head, maintains and ensures periodic review of quality objectives and operating plan
  • Leads oversight of QMS; coordinates the collation, reporting and interpretation of the highest-level summaries of performance, risk and issues to QRC sponsors
  • Supports RQA Head in other quality focused / strategic areas (and other QRCs) as required
• QMS Monitoring
  • Defines and reports Key Performance Indicator’s used to monitor QMS process health
  • Monitors effectiveness of cross functional QMS processes and identifies trends in data being generated by the QMS
  • Works with GXP pillar contacts to understand trends and propose enhancements
  • Presents summary of overall cross GXP QMS performance to Quality & Compliance Committee
• Risk Management
  • Co-ordinates cross functional deep dive analysis of metrics signals to understand any underlying areas of risk
  • Identifies and defines cross functional quality risks both from available data and analysis and prospectively in consideration of emerging trends or change both internally and externally
  • Able to articulate the overall state of control of the QMS as well as areas of opportunity/emerging risk to senior leaders, QOC’s and QRC’s as required
• QMS Continuous Improvement
  • Able to identify opportunities for improvement which may stretch across QMS’s (PGS, R&D, Commercial) and navigate appropriate accountability and oversight
  • Develops, implements and manages the process to gather, store and retrieve best practices/lessons learned for RDM QMS. Ensures this knowledge is communicated and shared with all relevant stakeholders and any agreed actions are tracked to completion
  • Actively seeks to avoid or address areas of duplication or dual standards across GXP pillars to ensure a consistent one Pfizer solution
  • Influences quality leads across GXP pillars to adopt standardized principles and approaches to common quality system elements
• Inspection Readiness
  • Ensures QMS processes are inspection ready. Works with inspection management team to prepare and review relevant samples of quality events and metrics for inspection review
• Quality Culture
  • Promotes broad understanding of the Pfizer Quality Management system
  • Promotes a culture of quality across organizations and partner lines
• Regulatory Expertise
  • Maintains appropriate level of expertise in US and International GCP/GLP/PV/GMP regulatory requirements, and policies and procedures within Pfizer that are applicable to the processes and systems within the scope of the RDM QMS (and other QMS’ as applicable)

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 8 years of experience; OR a master's degree with at least 7 years of experience; OR a PhD with 5+ years of experience
• Experience evaluating and understanding quality standards or their application.

Bonus Points If You Have (Preferred Requirements)

• 10+ years of pharmaceutical industry experience managing complex projects
• 7+ years of experience within the fields of quality, compliance, safety, manufacturing, or research and development environment
• Proven technical knowledge and application of root cause analysis (RCA) and CAPA activities covering the processes for the management of CAPAs for significant quality issues, regulatory inspection commitment execution, and other improvements necessary to eliminate causes, quality events and/or other undesirable situations
• Demonstrated in-depth knowledge of relevant global regulations and guidelines, as well as evolving legislation
• Excellent organizational, analytical, strategic, interpersonal, written and oral skills required
• Self-motivated and flexible with the ability to work effectively in a dynamic, problem-solving environment
• Strong ability to influence, negotiate, and communicate effectively at all levels of the organization

Physical/Mental Requirements

• Standard office work

Non-Standard Work Schedule, Travel Or Environment Requirements

• Domestic and International travel is required as deemed necessary.