Senior Manager, Inspection Management Lead

For more than 170 years, Pfizer has continuously worked to make a difference by delivering innovative therapies that improve the lives of our patients. By building a talented community of colleagues that align with our patient-focused purpose and core values, Pfizer has improved global health and impacted more than 780 million patients around the world.

In 2021, Pfizer expanded its global footprint to Tampa, establishing a strategic powerhouse that brings together multi-disciplinary, professional services including Finance, Accounting, Treasury, Digital, HR Services, Sourcing, Commercial and Project Management into a single, centralized location. With so many diverse and highly-skilled colleagues supporting multiple functions and services across the organization, Pfizer Tampa offers ample opportunity to engage in newer ways of working that enhance, simplify, and transform how we deliver treatments to our patients. 

Located in Heights Union, the Pfizer Tampa site offers a modern industrial design, the latest in innovative technology, and close proximity to Downtown with views of the Tampa Riverwalk and access to the Channel district and Bayshore Boulevard. From an onsite fitness center to top floor panoramic balconies and outdoor patio, our activity-based space will provide various ways of working to offer collaboration and flexibility to colleagues. The Pfizer Tampa site has constructed an atmosphere that fosters interaction and prioritizes colleague health and wellness.  

Additionally, to achieve breakthroughs that change patients’ lives, Pfizer is revolutionizing and evolving how colleagues work today. This year, Pfizer launched a new initiative that we call Log In For Your Day where a majority of colleagues can arrange with their manager to work remotely two or three days a week while still maintaining the ability to collaborate regularly in person at our sites. This flexible working model blends the best of remote work and on-site collaboration to drive greater flexibility, support work-life balance, and promote a vibrant, agile, and innovative culture.

ROLE SUMMARY

Science is the foundation of all that we do at Pfizer. We are seeking an Inspection Management Lead Senior Manager who will join a diverse team of dedicated professionals driven to significantly improve the lives of patients through his/her/their work at a company whose culture is committed to developing and nurturing diverse talent so that each colleague has the opportunity to build a fulfilling career.

Regulatory Quality Assurance (RQA) is an independent Quality audit function within the Compliance division, accountable to identify risks and non-compliance associated with Pfizer’s GxP regulated operations.

The Inspection Management Lead Senior Manager supports Pfizer by (as required) preparing for, organizing and supporting/leading Good Clinical Practice (GCP) and Pharmacovigilance (PV) inspections (sponsor, investigator site, vendor, as appropriate) conducted by global Health Authorities/Regulatory Authorities (HAs/RAs), and pharmacovigilance audits conducted by license partners, as appropriate. In addition, the Inspection Management Lead Senior Manager coordinates Pfizer responses to such inspections. The Inspection Management Lead Senior Manager may also provide support for other RQA activities in the region including, but not limited to; quality investigations, external stakeholder engagement, and Quality Management System support.

ROLE RESPONSIBILITIES

Leadership

• Serves as a member of the Inspection Management group supporting operational RQA strategies, policies and direction for Inspection Management

• Champions RQA mission and strategies throughout the RQA organization and among customers for efficient delivery of RQA and compliance activities

• Collaborates with business stakeholders to instill a culture of regulatory compliance and ensures effective and efficient management of inspection activities

• Serves as a strategic partner to quality/compliance/inspection readiness colleagues for inspection-related activities

• Interfaces with functional groups within RQA and customers to build knowledge of GCP/PV regulations and guidelines, and routinely engages in influencing the external environment through appropriate RQA activities (e.g. review of guidelines)

• Works with RQA functional lines and key customers to understand stakeholder needs

Risk/Quality Management

• Monitors trends in health authority inspection activities to proactively identify potential areas of risk for Pfizer

• Represents Pfizer in external meetings and conferences as required

• Liaises with relevant SOP and Training groups to promote continuous quality/process improvements based on inspection observations

• Evaluates inspection reports from various sources (e.g., HAs/RAs, other Pfizer quality groups) to identify issues of potential significance

Operational Excellence

• Collaborates with other RQA Inspection Management Leads and quality/compliance/inspection readiness colleagues in the BUs/RUs/Platform Lines for activities related to inspection preparation; Activities include but are not limited to preparation of relevant materials and conducting inspection-related training (e.g., inspection interview technique)

• Leads and/or supports pre-inspection visits of investigator sites

• Leads and/or supports management of global HA/RA inspections (GCP/GPvP, as appropriate) and ensures that roles and responsibilities have been defined and assigned for each inspection; Assumes a leadership role or other supportive roles during the inspection as required

• Works with members of the inspection team and other colleagues including, but not limited to, Head of Inspection Management, Head of RQA and Legal to ensure optimum responses are provided to address and resolve inspection findings

• Provides guidance to inspected parties regarding the completion of inspection corrective and preventative action plans (CAPAs)

• Coordinates and assists in the preparation, conduct and management of mock inspections as appropriate

• Develops and maintains policies, standard operating procedures (SOPs), tools, and guidelines as appropriate for preparation and conduct of inspections within Pfizer

• Prepares periodic summary reports related to Pfizer inspections

• Ensures that global contact lists, report distribution lists, and tracking lists used for inspection-related activities are updated and maintained

• Assists in identifying needs for updates to training materials, inspection readiness modules and documents required for the inspection readiness program

• Inputs inspection information and reports into appropriate RQA repositories and tools

• Engages in and supports the activities of the relevant RQA initiatives as appropriate to ensure alignment  in interpretation and dissemination of applicable regulations, guidance, and Pfizer policies and procedures to customers and stakeholders

• Maintains high level of expertise in international GCP/GPvP regulatory requirements, and policies, SOPs and project-specific procedures within Pfizer applicable to the clinical trial methodology and pharmacovigilance processes

• Fosters a work climate/culture within the team that exemplifies the Pfizer Values

• Takes accountability to communicate relevant and timely information relevant to the RQA LT, other RQA functions and stakeholders

BASIC QUALIFICATIONS

• Bachelor’s degree or equivalent experience is required. Advanced academic qualification/degree is preferred; equivalent relevant professional experience will be considered

• At least 8 years of relevant experience in clinical and/or pharmacovigilance QA, or other clinical quality management/QC role in biomedical science, clinical development, regulatory compliance

• Fluency in the English language (written and verbal) is a requirement for this position

• Experience evaluating and understanding quality standards or their application

• 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.  

PREFERRED QUALIFICATIONS

• Experience in interacting with health authorities (including but not limited to the US FDA, EMA, MHRA) or with other global regulators is highly desired.

• Ability to function autonomously in a matrix model and in a team environment

• Project management experience with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities a plus

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

 Travel Required (approximately): 30% 

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Quality Assurance and Control

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