Ledgent Technology · 5 hours ago
Senior Manager GCP/GVP
Alameda, CA
Full-time
Onsite
Senior Level
$66.66/hr - $73.33/hr
6+ years expLedgent Technology is seeking a Senior Manager GCP/GVP who will be accountable for Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP) systems and activities. The role involves driving compliance, implementing quality risk management, and partnering with various functions to ensure quality is integrated throughout clinical research and operations.
Staffing & Recruiting
Hiring Manager
Heather Walsh
Responsibilities
The Senior Manager GCP/GVP QA is accountable for Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP) systems and activities, drives compliance and continuous improvement, ensures that Quality is integrated throughout GCP/GVP processes, supports and conducts audits as requested using a risk-based approach, implements Quality Risk Management (QRM), tracks and trends key metrics, and ensures clinical data integrity
Develops and implements GCP and GVP functional strategy to support cross-functional deliverables to ensure that quality is embedded within all steps of Exelixis clinical research and operations
Identifies and drives continuous improvement, partnering with Product Development, Clinical Development, Clinical Operations, study and project teams, Medical Affairs, Regulatory, and Global Patient Safety, and other functions, as applicable
Aligns key QA strategies with business goals and understands the global regulatory compliance landscape
Represents QA as the QA Partner (Primary Point of Contact), speaking One Voice for Quality, for Exelixis business stakeholders, represents QA in an outwardly and business-facing capacity, in strategic and decision forums, and triages communication between Exelixis business functions, internally or externally, and QA, to provide and ensure delivery on company core goals and pipeline deliverables
Qualification
Required
BS/B.Sc preferably in the life sciences or STEM disciplines and a minimum of 6 years of related experience
Minimum of 6 years experience in biotech, pharmaceutical, or related industry or the equivalent combination of education/training and experience
Must have attention to detail and good investigation, problem solving, and organizational skills
This position requires a knowledge and experience with GxP processes related to managing vendors, partners, and suppliers
Familiarity with FDA Quality System Regulations and Pharmaceutical guidelines, 21 CFR Part 210 & 211, US and EU regulations, ICH guidelines and other industry standards
Administrative experience in organizing and maintaining vendor and audit related records
Proven organizational skills to obtain data across multi-functional groups and present results in a consolidated and clear manner
Keeps Management informed of status of assigned projects
Strong written and oral communication skills
Excellent attention to detail and organizational skills
Ability to influence decision makers and utilizes sound problem solving skills to recommend options and implement effective solutions
Highly skilled in the ability to work with ambiguity and complexity and can continuously modify options and solutions across all levels of the organization
Ability to contribute to the development of company objectives and key performance indicators
Strong user of Microsoft Office applications
Must have a good understanding of Good Clinical Practice and has work on clinical study teams as a Quality Representative
In-depth knowledge of ICH GCP E6 R3 and applicable global regulations and guidance for clinical development (e.g., FDA regulations, EU Regulations and Directives, MHRA Statutory Instruments, etc.)
Preferred
GMP drug development experience, GCP (clinical) QA support of a sponsor, CRO, or sites
Company
Ledgent Technology
Ledgent Technology, a business line of Roth Staffing Companies, utilizes proven processes and their robust professional network to place qualified technology professionals in contract, contract-to-hire, direct-hire roles and project teams throughout the US.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase