Director, Inspection Management Lead
3 weeks ago
ROLE SUMMARY
The Director, Inspection Management Lead supports Pfizer as required by preparing for, organizing and leading Good Clinical Practice (GCP), Good Laboratory Practices (GLP) 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 Director, Inspection Management Lead coordinates Pfizer responses to such inspections. The Director, Inspection Management Lead 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. The Director, Inspection Management Lead provides mentorship within the Inspection Management Team.
ROLE RESPONSIBILITIES
Leadership:
- Serves as a member of the Inspection Management group setting 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 functional leadership (e.g. WSR, POD, PRD) to develop Pfizer Inspection strategies- Collaborates with business stakeholders to drive a culture of regulatory compliance and ensures effective and efficient management of inspection activities- Serves as a strategic leader/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/GLP 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 pre-inspection visits of investigator sites- Leads management of local HA/RA inspections (GCP/GLP/GPvP, as appropriate) and ensures that roles and responsibilities have been defined and assigned for each inspection; Assumes a leadership role during the inspection, as required- Support global/sponsor HA/RA inspections (GCP, GLP, GPvP, as appropriate)
Qualifications:
Must-Have- Bachelor’s degree or equivalent.- 10+ years of relevant experience in clinical or pharmacovigilance QA, or other clinical quality management/QC role in biomedical science, clinical development, regulatory compliance;- 2+ years of direct experience in GCP and/or PV inspections.- Flexibility to engage global team members and stakeholders in disparate time zones.- Strong project management skills and experience are essential.- Demonstrated ability to manage multiple project (multitask) involving complex processes, competing deadlines, and shifting priorities.- Change agile, comfortable responding to unexpected demands with tight timelines, team player.- Fluency in the English language (written and verbal) is a requirement for this position.PREFERRED QUALIFICATIONS- Master’s or advanced degree preferred.- Experience working with regulators from FDA, Health Canada, MHRA and/or EMA.-
- Excellent interpersonal skills required; ability to understand and respond to multiple internal and external stakeholders.- Ability to influence stakeholders constructively and minimize conflict.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS- Variable - approximately 20% travel may be required
Other Job Details:- Additional Location Information: Groton, CT; USA - Remote; EU - Any Pfizer Site- Work Location Assignment: Must be able to work from assigned Pfizer office 2-3 days per week, or as needed by the business
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
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