Inspection Support Lead

Use Your Power for Purpose

The Inspection Lead serves as a pivotal architect of Pfizer's global GMP/GDP inspection and audit readiness strategy, driving alignment and excellence across PGS and Pharm Sci. This role orchestrates end-to-end inspection management—from proactive preparation through post-inspection optimization—ensuring 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 Pfizer's 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 Pfizer's 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 Pfizer's 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 bachelor's degree with at least 8 years of experience; OR a master's 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

The annual base salary for this position ranges from $162,900.00 to $261, In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 20.0% 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 | ). 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.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.  These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure.  Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.  Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.  If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Pfizer is an E-Verify employer.  This position requires permanent work authorization in the United States.

Pfizer endeavors to make  accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email  This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

Quality Assurance and Control

---