Driving GCP Quality by maintaining ‘quality’ line-of-sight for assigned asset/franchise
Ensure asset and/or franchise quality oversight, drive quality risk management and inspection readiness activities
Provide input and support to asset-assigned AQLs to ensure clinical development plan strategy and asset-level risks are incorporated
Strategically utilize quality measures/data to monitor asset/franchise quality and identify potential risks/quality trends
Set strategic framework for quality communication within asset/franchise

Requirements

A scientific or technical degree is preferred.
15 or more years of relevant experience (BS –10+ years or equivalent, MS/MBA – 9+ years or equivalent)
Highly skilled at building strong network/ knowledge/ relationships with internal/external stakeholders
Expert advanced knowledge, experience and expertise in clinical trial development, and operational quality management disciplines
Extensive knowledge of ICH GCP and regulations in order to assess GCP situations and coordinate resolution activities across partner lines
Familiarity with the relevant key therapeutic area(s)

Benefits

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
health benefits to include medical, prescription drug, dental and vision coverage

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial developmentoperational quality managementquality risk managementinspection readinessquality measuresdata analysisGCP regulationsICH GCPstrategic framework development

Soft Skills

network buildingrelationship managementstakeholder engagementcommunicationstrategic thinking