Quality Oversight Manager

Commercial Quality enables the Commercial Business and CMO to innovate and operate by providing consultancy, risk-based controls, and oversight to embed quality in user-centric, end-to-end business processes.

The CQ organization provides Quality Consulting and Quality Oversight to commercial colleagues across pharmacovigilance, patient support programs, data privacy, and promotional practices, this includes:

• Standardizing quality processes to drive consistency and enable the business to move at light speed
• Proactively addressing emerging regulatory and compliance risks
• Streamlining implementation and delivery of new and evolving processes
• Maximizing user experience and promoting self-service
• Building expertise and agility into the CQ workforce to create a “best place to work” environment

ROLE SUMMARY

The Quality Oversight Manager is a proactive, dynamic and results driven colleague who plays an essential role in delivering process oversight and leveraging actionable insights to drive positive impact to process quality and compliance.

The Quality Oversight Manager operates independently to execute quality monitoring and oversight activities (e.g., QE Management, Quality Reviews, and Quality Plan Management) for areas managed by CQ, assessing data, providing results and insights to the relevant stakeholders and supporting remediation to findings and process improvements to increase compliance and quality. This role will also partner with the extended team who execute oversight and remediation services and quality assure their outcomes.

Additional responsibilities include optimization of oversight tools and documentation, leveraging the capabilities of AI, to ensure these remain fit for purpose and risk aligned. This is a highly collaborative and visible role, combining hands-on-oversight execution with significant stakeholder engagement and the opportunity to inform the evolution of CQ processes adopting AI to the maximum extent

ROLE RESPONSIBILITIES

Accountable for:

 Quality Oversight and Monitoring

• Execute the end-to-end delivery of quality reviews ensuring findings are accurate and actionable
• Lead end-to-end Quality Event (QE) investigations, including evidence review with a root cause analysis, data analysis, and timely, accurate documentation
• Execute a non-QE issue process
• Analyse quality metrics to identify emerging risks and trends, challenge the status quo and translate into actionable insights that are shareable with internal and external stakeholders
• Partner with BPOs and Quality Process Design Leads to assess and detect the need for simplification, enhancements and/or changes to quality processes that drive efficiency and adoption of AI
• Oversee the design, governance and execution of centralised monitoring.

Issue Remediation

• Serve as the accountable subject matter expert for remediation activities
• Lead quality oversight remediation efforts (including quality reviews, audit and inspection findings) covering development of CAPAs that address the root cause appropriately and ensure the CAPAs are appropriately documented
• Provide oversight of vendor audit remediation activities escalating risks and issues, and partnering with vendors to develop and align CAPA plans.

Continuous Improvement and Commercial Quality Projects

• Identify and implement opportunities to leverage automation and AI to enhance oversight effectiveness and efficiency
• Lead and/or be an SME on assigned commercial quality projects

Stakeholder Engagement

• Represent quality team in relevant governance forums (e.g. to present quality review results) as needed
• Collaborate with Quality Process Design and Oversight team and BPOs to identify oversight process enhancements and continuous improvement opportunities
• Collaborate with other quality teams (e.g. RQA) across Pfizer, CQ colleagues and Commercial customers to share best practices related to quality oversight and remediation
• Identify, escalate, and present relevant quality issues (as needed)
• Liaise with CQ Leads and any other staff as well as QMC to conduct oversight activities and to support remedial actions

BASIC QUALIFICATIONS

• Bachelor’s degree in Sciences
• A minimum 4 + years of relevant work experience preferably in pharma
• Experience in audit and inspections
• Experience in quality oversight in pharma
• Quality and compliance driven mindset
• Excellent stakeholder m