Inspection Support Lead

Use Your Power for Purpose

The Inspection Lead serves as a pivotal architect of Pfizers global GMP/GDP inspection and audit readiness strategy driving alignment and excellence across PGS and Pharm Sci. This role orchestrates end-to-end inspection managementfrom proactive preparation through post-inspection optimizationensuring consistent adoption of best practices and agile adaptation to evolving regulatory landscapes and industry innovations.

the Inspection Lead designs and provides the process to fosters a high-performing Inspection ready network that anticipates challenges and leverages emerging regulatory trends to strengthen Pfizers competitive advantage.

Central to this role is the stewardship of continuous improvement: the Inspection Lead systematically captures insights from inspections and audits transforming learnings into actionable strategies that shape future audit frameworks and operational enhancements. This forward-looking approach ensures that Pfizer remains at the forefront of regulatory compliance and quality excellence.

The Inspection Lead may lead or participate in complex cross functional projects. This position contributes to enabling a culture of innovation excellence and continuous improvement of Pfizers Quality Management System through engagement with Pfizer sites to define best practices across the Pfizer manufacturing and supply network.

This role requires excellent leadership critical thinking and problem-solving skills as well as the ability to build cross-functional relationships and drive excellence in inspection management practices and to facilitate engagement team building best practice sharing risk-based analysis critical thinking and innovative problem solving.

What You Will Achieve

In this role you will:

Regulatory Intelligence & Enablement: Leads the development and evolution of regulatory intelligence platforms self-assessment tools and training programs equipping teams with the knowledge and resources to excel in inspection management. Champions the creation and deployment of innovative inspection management tools that drive operational efficiency and inspectional readiness.

Governance & Network Engagement: Owns the governance infrastructure and content of GMP/GDP inspection forums fostering robust engagement across the network to ensure unified standards and continuous knowledge sharing.

Enterprise Collaboration: Partners strategically with Audit Leads Planning and Metrics Leads and cross-functional stakeholders to ensure all Pfizer GMP/GDP sites and functions are equipped for successful audits and inspections. Facilitates seamless collaboration with Site Quality and Above Site Quality teams throughout the audit lifecycle from preparation to response creation .

Cross-Functional Leadership: Leads and influences complex enterprise-wide projects that advance innovation operational excellence and continuous improvement within Pfizers Quality Management System. Engages with sites to define and disseminate best practices driving a culture of excellence across the manufacturing and supply network.

Strategic Capabilities: Demonstrates visionary leadership advanced critical thinking and sophisticated problem-solving skills. Builds and sustains cross-functional relationships inspires engagement and team building and champions risk-based analysis and innovative solutions to elevate inspection management practices.

QUALIFICATIONS

Here Is What You Need (Minimum Requirements)

Applicant must have a bachelors degree with at least 8 years of experience; OR a masters degree with at least 7 years of experience; OR a PhD with 5 years of experience

Experience in progressive challenging experience in the biopharmaceutical and medical device industry required inclusive of quality control / assurance manufacturing and GMP/GDP auditing (may include Product Development).

Demonstrated ability to apply the following competencies and soft skills: business skills (negotiation logical reasoning critical thinking decision making presentation skills); leadership skills (persuasive communication active listening active learner); relationship skills (stakeholder management social perceptiveness relationship building); and supporting technical skills (technical writing digital acumen data analytics).

Must understand the elements and requirements of the Quality Management System at the Pfizer facilities contract manufacturers suppliers and GMP/GDP service providers audited.

Has a strong understanding of relevant regulatory and audit frameworks that apply to biopharmaceutical and medical device operations has in-depth knowledge of cGMP/GDP requirements and expectations is familiar with global regulations and internationally recognized standards (e.g. FDA EU Directive ICH TGA PIC/S ISO) and is capable of understanding and proactively monitoring emerging regulations and business / regulatory trends.

Critically evaluates information from the audit/inspection and able to identify risk areas in the field. Has the ability to recognize symptoms of problems or situations that require further evaluation and analyze symptoms to determine potential causes and identify possible solutions.

Can make both strategic and tactical recommendations and communicate effectively across all leadership levels. Anticipates potential objections and influences others to ensure appropriate outcomes. Takes the initiative and is willing to proactively propose and execute tasks as needed.

Actively leads or participates in cross functional teams for significant and complex projects and contributes towards outcomes that promote innovation and excellence.

Ability to conduct ad hoc assessments as required to support business needs.

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.

Bonus Points If You Have (Preferred Requirements)

• Experience in quality or operational roles in manufacturing environment and shop floor experience is desirable and Experience in preparing responses to audit findings and inspection observation.

ORGANIZATIONAL RELATIONSHIPS

• Directly partners with colleagues across RQA PGS and Pharma Sci including amongst other the audits lead metrics and planning lead and auditees from different functional lines within Pfizer PGS and Pharm Sci

RESOURCES MANAGED

• Working across RQA and with GMP/GDP leads as well as matrixed organization across PGS and PharmSci.

PHYSICAL/MENTAL REQUIREMENTS

Walking and standing as per travel requirements. Capability to perform data analysis and trending and prepare executive summaries.

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

Ability to travel up to 20% of the time including domestic and international traveling.

Work Location Assignment:Hybrid

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