: GCP/GLP Compliance Manager– Biotech (JP8258)
Thousand Oaks, CA 91320 (Remote until Covid-19 restrictions are lifted)
: 12 months with likely extension
CRDC - Global R&D Quality
Job posting date
3 Key Consulting is hiring GC_/GLP Compliance Manager for a consulting engagement with our client, a leading global bio-pharmaceutical company.
Top Must have Skill Sets:
- 5+ years GCP/GLP within pharma or bio tech and bachelor’s degree Minimum
To provide independent and objective compliance advice and oversight to the business in support of GCP and GLP activities
- Assess and manage risk, including providing input into the development of the annual audit program
- Collaborate with other compliance/quality functions to ensure aligned and comprehensive compliance support for R&D & GLP/GCP
- Participate as compliance representative in evaluating, qualifying and providing oversight of GCP/ GLP vendors
- Ensure escalation of significant compliance matters to appropriate compliance/quality oversight bodies
- Prepare, analyze and communicate compliance metrics (e.g., audit and inspection data) and other significant compliance information on periodic basis to key stakeholders and senior R&D management
- Maintain knowledge of current regulatory and compliance practices/issues.
- Triage and/or manage as appropriate R&D/GLP/GCP compliance matters arising in assigned geographic region.
Employee Value Proposition:
- Appropriate compliance background
- Regulatory inspections - hosting/ managing
- Direct clinical trial experience (compliance or clinical monitor)
- Clinical study management experience
- Good communication skills to partner with internal business partners
- Ability/ flex to multitask
- Manage workload and wear multiple hats
Exposure to R&D network, a lot of regulatory experience due to clinical filing activity
Lack of top 3 must have skills & years of experience, must come from pharma & biotech
Pre-Screen interview followed by Panel interview with staff
We invite qualified candidates to send your resume to email@example.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com
. You are welcome to also share this posting with anyone you think might be interested in applying for this role.