Full-Time

Senior Specialist

Global Quality Management, Good Laboratory Practices

Confirmed live in the last 24 hours

Cerevel Therapeutics

Cerevel Therapeutics

201-500 employees

Develops therapies for central nervous system disorders

Biotechnology

Senior

Remote in USA

Required Skills
Communications
Management
PowerPoint/Keynote/Slides
Requirements
  • Proven experience in quality assurance role within the pharmaceutical or biotechnology industry
  • 5 + years of Quality experience required, including direct GLP audit experience across various audit types
  • Knowledge of GLP regulations, guidelines, and industry best practices
  • Strong analytical and problem-solving skills
  • Detail-oriented with a high-level of accuracy and integrity
  • Strong project management, interpersonal, and communication skills
  • Skilled user of Microsoft Office applications such as with Word, Excel, PowerPoint, and Outlook
  • Ability to travel as needed to support quality and inspection activities
Responsibilities
  • Partner with Safety Assessment & Research Operations to understand development programs and related risk factors to drive audit planning & scheduling
  • Develop risk-based audit strategy to support pre-clinical programs
  • Plan and conduct internal, external, routine and for-cause GLP audits worldwide, including audits in preparation for regulatory inspections
  • Ensure timely responses to audit findings and implement corrective actions as necessary
  • Guide functional teams through the deviation/CAPA process to ensure robust investigation, timely action, and meaningful improvements to process
  • Perform Quality Control of documents and data as requested by project teams
  • Using quality management system tools, analyze audit findings and deviation trends to drive continuous improvement
  • Liaise with external contractors conducting audits on behalf of Cerevel
  • Train staff on regulatory requirements, quality management processes and procedures, and inspection readiness
  • Prepare for and participate in regulatory inspections and compliance audits related to GLP activities
  • Conduct risk assessments to identify potential areas of non-compliance and implement risk mitigation strategies
  • Collaborate with teams to establish and maintain a culture of continuous improvement in quality assurance
  • Stay current with updates to GLP regulations and communicate changes to stakeholders
  • Collaborate with cross-functional teams to establish and enhance quality systems that support GLP compliance
  • Represent Cerevel in external industry groups, forums, conferences, and/or professional associations
  • Lead and/or participate in projects and/or departmental initiatives or other duties as assigned

Cerevel Therapeutics is dedicated to developing experimental neuroscience therapies for central nervous system disorders, focusing on understanding neurocircuitry deficits to unlock new treatment opportunities.

Company Stage

IPO

Total Funding

$1.8B

Headquarters

Cambridge, Massachusetts

Founded

2018

Growth & Insights
Headcount

6 month growth

7%

1 year growth

13%

2 year growth

54%