Senior Manager
Global Product Quality
Posted on 2/3/2024
INACTIVE
Cerevel Therapeutics

201-500 employees

Develops therapies for central nervous system disorders
Company Overview
Cerevel Therapeutics stands out as a leading biopharmaceutical company with a concentrated focus on developing therapies for central nervous system disorders, a field that impacts hundreds of millions globally. Their competitive edge lies in their robust portfolio of experimental neuroscience therapies, including three clinical-stage compounds and several pre-clinical compounds, targeting a wide range of disorders such as Parkinson’s, Alzheimer’s, and epilepsy. The company's culture is driven by a commitment to understanding neurocircuitry deficits, which fuels their research and development efforts towards addressing these underserved areas and communities.
Biotechnology

Company Stage

N/A

Total Funding

$1.8B

Founded

2018

Headquarters

Cambridge, Massachusetts

Growth & Insights
Headcount

6 month growth

7%

1 year growth

15%

2 year growth

57%
Locations
Remote in USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Quality Assurance (QA)
CategoriesNew
Medical, Clinical & Veterinary
Diagnostics & Laboratory Professionals
Healthcare Administration & Support
Requirements
  • 8+ years of relevant QA experience in pharmaceutical or biopharmaceutical industry
  • In-depth knowledge of GMP/GLP QA principles and standards
  • Experience working and managing CDMOs/CMOs
  • Strong understanding of the Drug Development Process
  • Ability to travel as needed, may be up to 30% domestic travel, occasional international travel may also be expected
Responsibilities
  • Provide Quality oversight for GMP/GLP activities at Cerevel and its global vendors
  • Apply cGMP principles and requirements in a phase-appropriate manner
  • Review and approve GMP documentation, including Master Batch Records, Specifications, Analytical Test Methods
  • Review, approve and track Cerevel’s and/or vendors’ product quality investigations
  • Participate in and/or support Quality audits (internal and external)
  • Support vendor qualification activities
  • Lead preparation for CDMO/CMO inspection readiness when required