Director, Inspection Management Lead
Job Description
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.
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
Master’s or advanced degree preferred.
Experience working with regulators from FDA, Health Canada, MHRA and/or EMA.
Prior experience in organizations or with applications for continuous improvement or metrics trending highly desirable.
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:
Last Date to Apply for Job: 24 April 2024
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
The annual base salary for this position ranges from $149,200.00 to $248,600.00. 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 | (uscandidates.mypfizerbenefits.com). 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 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.
