Process Lead Incoming Materials Inspection Controls (Secondment - 12 Months)

Pfizer • New York City, NY

2d • Hybrid

About The Position

The Process Lead for Incoming Materials Inspection Controls (IMIC) is a global subject-matter expert within Pfizer’s Supplier Quality Management (SQM) team. Reporting to the Senior Director, Supplier Quality Management/Global Process Owner (GPO), the role operates under authority delegated by the GPO to advance an efficient, standardized, compliant, and risk-based IMIC process that meets regulatory expectations and industry best practices.

The role applies expertise in incoming material testing, supplier and material qualification, quality risk management, and reduced-testing strategies to assess complex challenges, identify systemic risks and opportunities, and recommend practical solutions. It leads and influences the day-to-day work of the global Level 2 Process Centric Team (PCT) and coordinates cross-functional initiatives with Local Process Owners (LPOs), other Process Leads, GPOs, and stakeholders. As an individual contributor, the role achieves results through technical expertise, project leadership, collaboration, and influence rather than direct reporting authority.

The Process Lead evaluates current practices and network performance, aligns IMIC with related Quality Management System processes, and leads implementation plans for approved changes. It oversees the creation and lifecycle management of global procedures, work instructions, forms, templates, decision tools, training, and guidance. The role monitors process health and KPIs, escalates significant issues through governance, and presents updates and proposals to process sponsors, management review forums, and Quality leadership. It also supports stakeholder understanding and adoption of changes and maintains expertise in applicable regulatory requirements and Pfizer policies and procedures.

The position is a 12-month secondment, is considered flexible, and has no change to the employee’s current work location. Colleagues are expected to comply with Log In For Your Day requirements at their site, such as approximately 2.5 days per week in the office. The role is posted at Pfizer sites in North America and Europe. Relocation assistance may be available based on business needs and/or eligibility; the posting also states that the role is not eligible for a relocation package.

Requirements

• Bachelor’s degree and at least 6 years of experience; or a master’s degree and at least 5 years of experience; or a PhD and at least 1 year of experience.
• Demonstrated subject-matter expertise in Incoming Materials Inspection Controls, incoming material testing, sampling or inspection strategies, and risk-based testing principles.
• Knowledge of Good Manufacturing Practice and Good Distribution Practice requirements and regulatory expectations applicable to incoming materials, laboratory controls, supplier qualification, and material qualification.
• Strong understanding of process ownership, governance, quality risk management, performance monitoring, change management, and continual improvement.
• Ability to lead through influence across global, cross-functional, and matrixed teams.
• Ability to interpret performance data, identify systemic risks and trends, and translate insights into clear priorities and decisions.
• Effective communication, facilitation, stakeholder management, and escalation skills.
• Proven ability to drive continuous improvement initiatives.
• Candidates must be authorized to work in the United States; U.S. work visa sponsorship is not available now or in the future.
• The position requires permanent work authorization in the United States.

Nice To Haves

• Advanced degree in a scientific or healthcare-related field.
• At least 10 years of experience in Quality, Lab Operations, or a related field in the pharmaceutical, biotechnology, or medical device industry.
• Breadth of diverse leadership experience and capabilities, including influencing and collaborating with peers, developing and coaching others, and overseeing and guiding colleagues’ work to achieve meaningful outcomes and business impact.

Responsibilities

• Evaluate incoming material testing practices, regulatory expectations, industry trends, and network performance to identify opportunities for standardization, simplification, and risk-based testing.
• Align IMIC with supplier qualification, material qualification, supplier monitoring, laboratory controls, change management, and other interdependent QMS processes.
• Develop and lead global implementation plans for approved process changes, including stakeholder engagement, impact assessment, communications, training, deployment, and effectiveness monitoring.
• Lead development, revision, and lifecycle management of global standard operating procedures, work instructions, forms, templates, decision tools, and supporting guidance.
• Keep process documentation current, internally aligned, practical for end users, and ready to support regulatory inspections and internal audits.
• Lead development and delivery of training, guidance, job aids, workshops, and other capability-building resources for LPOs, site colleagues, and relevant stakeholders.
• Provide technical coaching and process guidance to support consistent interpretation and application of global requirements.
• Lead day-to-day activities of the global Level 2 PCT by setting priorities, structuring work, facilitating decisions, and coordinating deliverables across geographically dispersed members.
• Monitor process health and performance using global KPIs and metrics agreed with the GPO; identify risks and adverse trends, escalate significant issues, and present updates through defined governance channels.
• Represent the IMIC Process in the Tier 3 GPO Forum for cross-process learning and QMS input and improvements.
• Prepare and present process-health updates, risk assessments, improvement proposals, decision requests, and cross-process issues to process sponsors, management review forums, and Quality leadership.
• Help stakeholders understand the purpose, benefits, and impact of process changes; anticipate change impacts and communicate approved changes to business leaders.
• Influence stakeholders across organizational levels to support consistent process interpretation, timely decisions, effective implementation, and sustained performance.
• Maintain expertise in regulatory requirements and Pfizer policies and procedures applying to Supplier Qualification and Management, including incoming material expectations.

Benefits

• Relocation assistance may be available based on business needs and/or eligibility, although the posting also states the position is not eligible for a relocation package.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior