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Senior Manager
Global Product Quality, Late Phase/Commercial Operations
Confirmed live in the last 24 hours
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.

Company Stage


Total Funding





Cambridge, Massachusetts

Growth & Insights

6 month growth


1 year growth


2 year growth

Remote in USA
Experience Level
Desired Skills
Customer Service
Quality Assurance (QA)
Operations & Logistics
Customer Success & Support
  • 8+ years of relevant QA experience in pharmaceutical or biopharmaceutical industry in manufacturing, QA or QC role supporting GMP Activities for Investigational Medicinal Products and/or Commercial Products
  • In-depth knowledge of GMP/GLP QA principles and standards, as well as thorough understanding of FDA, EMA and ICH quality regulations necessary for day-to-day operations of commercial supply operations
  • Experience in working and managing CDMOs/CMOs to conduct GMP manufacture, testing, packaging/labeling, and/or distribution
  • Experience in authoring and implementing SOPs
  • Experience with Regulatory/Health Authority Inspections
  • Experience working in electronic quality management systems (Veeva or equivalent)
  • Experience with electronic Learning Management Systems
  • In depth knowledge of Validation Lifecycle requirements
  • Understanding of GAMP Validation Guidelines and Validation lifecycle requirements
  • Strong understanding of the Drug Development Process; ability to partner and build relationship with business function stakeholders and external vendors in order to enable high quality outcomes
  • Technical writing experience; writing investigations, performing root cause analysis, and identifying CAPAs
  • Analytical problem solving and decision-making skills
  • Highly motivated, flexible and able to respond quickly to shifting priorities and meet deadlines, with excellent organizational skills and keen attention to details
  • Strong verbal and written communication skills to effectively communicate with business functions and vendors
  • Ability to travel as needed, may be up to 30% domestic travel, occasional international travel may also be expected
  • Bachelor's degree in life science (or equivalent) or engineering field relevant to pharmaceutical development; significantly more work experience in the relevant areas may be required for candidates without a bachelor's degree
  • Provide Quality oversight for GMP/GLP activities at Cerevel and its global vendors, which includes Contract Research Organizations (CROs), Contract Development Manufacturing Organizations (CDMOs), and Contract Manufacturing Organizations (CMOs)
  • Apply cGMP principles and requirements in a phase-appropriate manner to support the development and manufacture of commercial products while ensuring quality and compliance with Cerevel's procedures and applicable health authority's regulations
  • Review and approve GMP documentation, including Master Batch Records, Specifications, Analytical Test Methods, Stability Protocols/Reports, Validation Protocols/Reports, Change Controls, and Label Proofs in support of manufacturing, testing, and packaging/labeling at various vendors
  • Review and approve vendors' executed batch records, analytical data, packaging and labeling records, to ensure timely disposition of drug substances, drug products and finished goods for use in commercial operations
  • Review, approve and track Cerevel's and/or vendors' product quality investigations, included but not limited to, deviations/nonconformances, CAPAs, out of trend (OOT), out of specification (OOS), product quality complaints, associated with manufacturing and analytical/stability testing
  • Work proactively and effectively with vendors and respective Cerevel business functions to identify and mitigate quality risks/issues that may arise to maintain compliance and preserve projects' timelines
  • Participate in and/or support Quality audits (internal and external) with the support of external quality consultants/auditors. Support vendor qualification activities, which may include auditing and approving of GMP/GLP vendors, providing recommendations, and following up on audit responses and resolution of CAPAs
  • Ensure Cerevel and vendors are in compliance with US and Global regulations, guidelines and industry standards in countries where Cerevel conducts GxP activities. Serve as a Person-in-Plant (PIP) at vendors, when needed
  • Lead preparation for CDMO/CMO inspection readiness when required
  • Review CMC regulatory filings and supporting documentation, as needed
  • Develop and oversee GPQ metrics/KPIs and report results to Senior Management
  • Serve as GPQ Representative in collaborating with Information Technologies and Quality Management in the selection, implementation, and maintenance of GxP electronic quality management systems and applications (e.g., Veeva Vault - QMS)
  • Support the development, implementation, and maintenance of Cerevel's procedures and electronic Quality Management Systems
  • Partner with stakeholders throughout lifecycle of quality systems implementation and continuous improvement - from defining business need, project planning, development, deployment, and end user adoption - and provide ongoing GMP functional oversight for all electronic quality management systems
  • Additional Quality projects and responsibilities may be assigned based on business needs of a growing organization
Desired Qualifications
  • 2+ years of supplier quality experience managing GMP/GLP Vendors
  • Previous experience working in a commercial Quality role
  • Desire to work in a fast-pace, dynamic environment
  • Strong team player with a solutions-oriented and customer-service mind-set
  • Excellent interpersonal, problem solving with high degree of autonomy
  • Organized and efficient; delivers high-quality work
  • Experienced at leading teams and developing talent
  • Ability to coordinate timelines with internal customers and vendors