Diagnostics PMO Lead (Secondment - 8 months)

Why Patients Need You

At Pfizer, technology impacts everything we do. Our strategy focuses on implementing impactful and innovative technology solutions across all functions, from research to manufacturing. Whether you are revolutionizing drug discovery and development, identifying solutions, or making our work easier and faster, you will be making a difference to countless lives.

The Diagnostics PMO Lead will have responsibility for Pfizer’s Companion Diagnostics end-to-end process development.

What You Will Achieve

The incumbent provides leadership/guidance for Companion Diagnostics related Pre-Clinical, Clinical, and Commercial activities from Assay Feasibility through Post-Launch including design controls (21 CFR 820), Quality Management Systems (ISO 13485), risk management (ISO 14971), In Vitro Diagnostic Directive Regulation (IVDR), Clinical Laboratory Improvement Amendments (CLIA), clinical trials, vendors, complaints, post-market surveillance, regulated body inspections, applicable internal procedures, and other applicable regulatory requirements throughout the product lifecycle.  

How You Will Achieve It

• Develop and lead/co-lead highly complex projects, crafting mid-term plans that significantly impact results.

• Leverage cross divisional and cross functional relationships to meet the needs of developing an end to end process to support diagnostics

• Make decisions in complex problems, identify innovative options and solutions, and recommend courses of action impacting.

• Develop and lead enhancement plans for post-market diagnostic assets and partnerships in-alignment with therapeutic program development and commercial objectives

• Craft a project execution plan and pinpoint the necessary technical and business resources for the team to support on-time delivery of milestones and strategic objectives for the project.

• Serve as a subject matter expert and manage critical processes and strategy projects that contribute to efficient, effective, and compliant quality assurance processes.

• Develop and implement the strategy for a comprehensive quality control/monitoring program that facilitates consistency and compliance with SOPs, work instructions, Corporate and Healthcare Compliance policies and Regulatory requirements and enables monitoring of processes and standards.

• Lead the identification and initiation of continuous process improvements to enhance the quality of operations, systems and services evaluating compliance with applicable GxP requirements. 

• Develop the strategy to provide, implement and manage an easily accessible, centrally controlled document management system to store local SOP’s, guidelines and other standard documents and templates. 

• Lead/Participate on cross functional projects teams and share knowledge and best practices with Pfizer counterparts.

• Devise training needs for colleagues and partners with regards to procedures, policies and systems and the development of training plans to meet the needs of the business.  

• Partner with cross functional leadership in the development of strategies, specifically by proactively identifying risks, providing guidance on risks and overseeing mitigations across global functions. 

• Drive innovative approaches for risk management and mitigation across existing and emerging risk areas to establish consistent approaches. Includes development of uniform risk assessment (including thresholds) and mitigation measures framework. 

• Maintain appropriate level of expertise in US and International regulatory requirements, and policies and procedures within Pfizer that are applicable to the processes and systems within the scope of the business unit.  

Qualifications

Must-Have

• BA/BS with 8+ years of experience or MBA/MS with 7+ years of experience or PhD/JD with 5 + years of experience or MD/DVM with 4+ years of experience

• Expertise in 21 CFR 820, ISO 13485, IEC 62366, IEC 62304, ISO 14971, In Vitro Diagnostic Directive Regulation (IVDR), ISO 61010, Clinical Laboratory Improvement Amendments (CLIA).

• Expertise on internal procedures, medical device / MDCP regulations, and the Quality Management System (QMS).

• Demonstrated expertise in facilitating teams and gathering requirements for business process improvement

• High level of business knowledge and understanding of the external marketplace

• Strong business engagement and knowledge sharing capabilities

• Proven track record of delivering complex projects on time and within budget

• Ability to make decisions in complex problems and identify innovative solutions

• Experience in developing and leading highly complex projects

Nice-to-Have

• Experience in driving transformation initiatives and developing innovative ideas

 
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.
 

Other Job Details

• Last Date to Apply for Job: April 10, 2025

• Additional Location Information: North America - Any Pfizer Site, North America - Remote

• Eligible for Relocation Package – NO

• Secondment 8 months

• If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for 12 months or longer, you will be required to turn in your fleet vehicle for the duration of the non-driving secondment.  Please refer to the Fleet Policy and Procedures document for more information.

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