The Inspection and Risk Management Lead will drive the quality culture in Global Clinical Supply (GCS) by providing strategic leadership, oversight, and continuous improvement of key activities integral to Global Clinical Supply business quality and compliance efforts.  They are accountable for quality management activities, including establishing, managing, and maintaining GCS-wide practices with the goal of evolving quality approaches, reducing quality events, and contributing to compliant inspections and audits involving GCS.  Focus areas include quality records management, quality metrics compliance, audits and inspection readiness and governance.

The IRM Lead develops talent by ensuring Quality Investigation Leads (QILs) and Inspection Readiness Leads (IRLs) are trained, supported, and positioned to deliver successfully. They ensure direct reports meet expectations, appropriately escalate risks, and drive process improvement.  They are accountable to ensure QILs and IRLs are following Pfizer Standard Operating Procedures (SOPs) and providing leadership and appropriate oversight to the matrix colleagues in the GSH hubs.   

The IRM Lead directs trending and analysis of quality data to proactively identify risks, coordinates with GCS and Quality partners to resolve issues, and leads or supports Quality Governance.

As a Subject Matter Expert in quality investigations and inspection readiness, the IRM Lead fosters best practice sharing across teams.

The IRM Lead will interface as needed with key stakeholders across the organization including but not limited to GCS functional lines, PSOQ, other CD&O functional lines, RQA, Corporate Affairs, to ensure appropriate issue resolution/escalation and healthy stakeholder relationships. 

The IRM Lead represents IRM and GCS in cross functional or enterprise level initiatives that influence senior leadership and strategic direction.  They are part of the IRM LT and GCS eLT, contributing to driving strategic initiatives to evolve IRM and GCS.

This role is accountable and responsible for the following activities across all functions in Global Clinical Supply, with quality records, quality metrics, and audit and inspection as the focal point.

Line Management

• Manages, leads, and oversees the Inspection Readiness and Quality Investigation functions in IRM ensuring appropriate training through formal and experience-based assignments. 
  • Line management of GCS Quality Investigation Leads (QILs), including matrix management of hub colleagues
  • Line management of GCS Inspection Readiness Leads (IRLs)
  • Matrix management of the GSH Quality Management Specialists
• Actively develops and retains talent through provision of focused career development, performance management, and an inclusive culture  
• Leads Hiring, Selection and Training of New Hires, and creates Training Plans for IR Leads and QI Leads.

Quality Investigations

• Main point of contact for all GCS related quality records
• Works with GCS functional lines, PSOQ and CD&O to ensure appropriate and timely processing and closure of records.
• Supports PSOQ procedural updates as needed, bringing the IRM and GCS line perspectives
• Supports the review and triage of GCP QE Assessment notifications.  Collaborates with GCS, PSOQ, and CD&O functions to ensure appropriate processing as needed.
• Determines strategy for appropriate documentation of quality issues, i.e., Quality Event, Deviation Record, CAPA Record, Change Management
• Escalates issues to Head of IRM, document actions.
• Oversees Quality Record assignments.
• Monitors workload and support Quality Investigation Leads to ensure a consistent, compliant, and timely investigation process. 

Audits & Inspections

• Main point of contact for all GCS related audits and inspections
• Works with RQA, CA, and GCS and CD&O functional lines
• Leads standing internal IRM IR meeting to share learnings and discuss questions related to past and upcoming audits or inspections
• Oversee compliance with PTMF requirements, proactively monitoring metrics and communicating to GCS functional lines to ensure timely and quality submission of documents to proactively support audits and inspections.
• Primary escalation point of contact for audits and inspections, ensuring appropriate focus and level of preparation aligned with portfolio submission strategy.
• Oversee assignments and monitor Inspection Readiness Lead workload for Process Audits (Regulatory Quality Assurance (RQA), Corporate Audit), Regulatory Inspections (Sponsor and Investigator Site) and RQA Investigator Site Audit Findings (if requested) to ensure a consistent, compliant, and timely readiness and processing of findings.
• GCS liaison to GCSO Asia International Operations, GCP Quality Group, RQA, and CA (Corporate Audit) for inspection readiness and audit/inspection management functions, ensuring GCS is effectively prepared for GCP audits and inspections, identifying and promoting opportunities to improve overall health of the IR process for clinical supplies, ensuring all queries / observations are addressed
• Oversee requests for quality remediations and ensure they are handled in a timely and coordinated manner, managing follow-up activities involving both routine & complex matters
• Escalate issues to Head of IRM, document actions.

Subject Matter Expertise 

• Represent GCS at Quality Management Review Boards and liaise with other Quality organizations to ensure overarching alignment in strategic approach around investigational product
• Drive quality culture at all levels within GCS and at partner interfaces, and drive consistency across GCS in approach to quality
• Identify, share and implement best practices; ensure consistency in overarching processes & systems, where needed; develop partnerships with key colleagues in other functional areas to ensure ongoing alignment & efficiency.
• Direct the development and evaluation of trending exercises with available quality data to proactively identify areas of concern and highlight need for mitigation
• Digital & Process Innovation
  • Progress technological enhancements in tools used by GCS IRM
  • Evaluate, propose and lead process enhancements efforts
  • Champions automation initiatives to streamline workflows.
  • Partners with digital representatives to implement intelligent solutions.

Leadership

• The IRM Lead is part of the IRM LT and GCS eLT, contributing to driving strategic initiatives to evolve IRM and GCS.

Basic Qualifications:

Training & Education

• A minimum of a BA or BS is required, advanced degree in relevant Life Sciences, Pharmacy, or related field

Prior Experience

• Minimum 15 years of pharmaceutical experience with strong experience in clinical supply chain and clinical studies (including a strong understanding of the related planning and operational processes), GMP/GCP Quality, compliance, risk and issue management
• Experience in Inspection/Audit readiness
• Experience in quality investigation processes.
• Experience and demonstrated track record in the management and direct supervision of internal resource 
• Demonstrated effectiveness working in a multidisciplinary, matrix team environment   
• Strong risk, quality and/or compliance experience
• Strong knowledge of GMP requirements, GCP requirements and applicable SOPs and regulations

Skills

• Strong people management skills, including developing and coaching others.
• Strong organizational and planning skills, with a keen attention to detail
• Strong project management skills and ability to prioritize multiple and complex projects while meeting targeted deliverables and deadlines
• Strong analytical and problem-solving abilities.
• Ability to work independently with limited guidance
• Ability to adapt to changing situations and work well under pressure
• Strong and effective verbal and written communication skills.  Uses a variety of communication tools and techniques to present complex ideas; anticipates potential objections and influences others
• Excellent stakeholder management skills.
• Ability to lead cross-functional initiatives and drive continuous improvement.
• Proven ability to function autonomously in a matrix model and in a team environment
• Technical proficiency/expertise, including skills in use of common desktop tools (MS Word, MS Excel, MS Project, Visio); Office365 and SharePoint; CoPilot, tools for analysis and graphing; reporting (Spotfire); and systems for document management and learning management

Preferred Qualifications:

• Advanced degree in Life Sciences
• Thorough understanding of clinical supplies and clinical studies, and of the related planning and operational processes.
• Thorough knowledge of GMP requirements, GCP requirements and applicable SOPs and regulations
• Demonstrated experience in supporting continuous improvement projects.
• Evidence of strong leadership, influencing, negotiation, and management skills
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Travel will be minimal.

May include domestic and international travel to GCS sites.

Will periodically require working across US, EU, Asia hours to support activity and/or engagement with global colleagues.

Work Location Assignment: Hybrid - must be onsite an average of 2.5 days per week.

The annual base salary for this position ranges from $214,900.00 to $341,100.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 22.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Quality Assurance and Control