Senior Manager, Clinical Quality Assurance
Irvine, CAAll locationsIrvine, CANorth Chicago, IL, United StatesSouth San Francisco, CAWorcester, MASan Francisco, CA Hybrid
$124,500–$236,500 a yearJobFig found this opening at its original source and checks that it remains available.
About the role
As the primary GCP quality interface cross-functionally in R&D for the product, this individual will influence and provide oversight of activities that include execution of the Comprehensive Quality Strategy game plan, informal surveillance, assessments as appropriate, design and execution of a “fit for purpose” audit program with the goal of submission-ready quality data, first pass approvals by health authorities for market authorizations, and bringing our compounds to our patients. This is an independent contributor role that will influence across matrix organizations.
What you'll bring
- Bachelor’s degree in a physical science, life science, nursing, pharmacy or equivalent
- 5+ years of pharmaceutical industry experience in GCP quality assurance or regulatory affairs or clinical development or clinical operations.
- Successful and progressive leadership experience in motivating teams to anticipate and deliver strong operating results, as well as to meet or exceed customer expectations.
- Problem solving abilities required at both strategic and operational levels, ability to identify and resolve issues related to quality and compliance with global and local regulations, polices, and procedures.
- This involves both internal cross-functional problem solving as well as issue resolution between functional areas and external collaborators.
- Demonstrated ability in strategic planning and cross functional execution
- Proven track record utilizing core and technical competencies in managing projects in support of clinical research
- Strong understanding of global Pharma, clinical development and operations, legal and regulatory environments
- Experience in preparing/presenting key information
- Comprehensive knowledge of the interrelationship among other RDQA GXP functions and with business functions to serve as a good business partner
- Prefer 1+ years of GCP QA auditing experience
- oncology-specific a plus, but not a requirement