Job Description
Must have 10+ Years of
relevant experience
- Lead
the R&D Quality and Manufacturing team to manage GCP (good clinical
practice) and GPV (good pharmacovigilance practices) inspections by global
regulatory health authorities.
- Provide
strategies and oversight for global planning-preparations and clinical
investigations.
- Build
systems and tools to support and oversee end-to-end inspection readiness
and inspection management training.
- Develop
staff competencies and capabilities in inspection readiness, inspection
conduct, and CAPAs. Collaborate
with teams and SMEs to investigate and resolve inspection readiness gaps
prior, during and post inspection. Support
CAPA development and perform CAPA effectiveness checks for inspection
findings.
- Contribute
regulatory and quality strategies for the preparation of inspection risk
assessments for senior management and key stakeholders.
- Review
QMS (Quality Management System) policies and processes for inspection readiness
- Provide as-needed liaison to client’s partner and vendor inspections.
Work
Schedule
- Full
time (40 hrs/week)
- 4 days/week
on-site
- Remote
for remaining time
- Location:
San Francisco Bay Area
- Duration:
6 months
Type: Contractor
About
Protocol Link, Inc.
Headquartered in Chicago metropolitan area, Protocol Link is a leading project management and strategy consulting firm providing comprehensive regulatory affairs, cGMP compliance, quality assurance, and validation services to the FDA-regulated companies worldwide. Protocol Link’s mission is to provide customer-focused services with ethical conduct, mutual trust, and personnel empowerment while striving to offer the best of both quality and efficiency. It's how we've been doing business since 1996. The right way.