QA Program Manager (GCP, GLP, GVP)
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Job Location:
Sunnyvale, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
We are seeking an experienced GCP GLP and GVP Quality Assurance Program Manager who will serves as a hands-on embedded Quality Assurance resource supporting clinical research nonclinical and pharmacovigilance activities for early- to late-stage pharmaceutical development focused on fluorescence imaging technologies.
This role works directly with Clinical Research and other cross-functional teams on-site providing day-to-day quality guidance real-time issue resolution and active participation in study execution. The position requires demonstrated experience conducting GCP GLP and GVP audits and is designed for a quality professional who thrives in a highly interactive operational environment rather than a purely oversight-based role.
Roles and Responsibilities
-Act as an on-site QA partner embedded within Clinical Research and development teams
Provide real-time hands-on quality guidance during study planning execution and close-out
Support quality decision-making using a risk-based phase-appropriate approach
Support clinical trials nonclinical studies and pharmacovigilance activities in compliance with global regulations
Plan and conduct GCP GLP and GVP audits (internal service provider and study audits)
Support regulatory inspections and inspection readiness activities
Lead deviation investigations root cause analyses and CAPA implementation
Qualify and oversee CROs laboratories and PV service providers
Qualifications :
Basic Qualifications
Bachelors degree in Life Sciences or related discipline
7 years of pharmaceutical or biotech QA experience
Direct experience conducting GCP GLP and GVP audits
Strong knowledge of FDA EMA and ICH requirements
Preferred Qualifications:
Experience supporting early- to late-stage nonclinical clinical and drug safety development programs
Experience with imaging agents diagnostics or combination products
Regulatory inspection experience
Service provider non-clinical and clinical research sites CRO internal process audits and inspection support.
Additional Information :
Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.
Mandatory Notices
U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR 743.13(b)) some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.
Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the governments licensing process can take 3 to 6 months) or (ii) implement a Technology Control Plan (TCP) (note: typically adds 2 weeks to the hiring process).
For any Intuitive role subject to export controls final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employeesstart date which may or may not be flexible and within a timeframe that does not unreasonably impede the hiring need. If applicable candidates will be notified and instructed on any requirements for these purposes.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.
We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target compensation ranges are listed.
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Project Management Methodology
- Project / Program Management
- Program Management
- Management Experience
- Microsoft Powerpoint
- Project Management
- Microsoft Project
- Budgeting
- DoD Experience
- Leadership Experience
- Supervising Experience
- Contracts
About Company
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As pioneer and leading company in the field of robotic-assi ... View more
