Senior Manager Product Complaints & Quality Systems bei Cerevel Therapeutics

Company Overview

Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders, including schizophrenia, epilepsy, Parkinson’s disease and substance use disorder.  

Headquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people’s lives.

Cerevel aspires to develop and nurture a culture characterized by trust, respect, courage, curiosity, and compassion, with a relentless focus on mission and results.  Our patient-centricity guides our purpose, how we treat each other and what we work on every day.  The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions.

Role Summary

The Senior Manager, Product Complaints & Quality Systems will be responsible for the design, development, implementation, and maintenance of the product quality complaints management system for R&D and commercial products in a manner that is compliant with regulatory requirements and business needs in terms of receiving, documenting, investigating, resolving, and responding to product quality complaints and other post-market feedback.

This role is also responsible for the oversight and monitoring of GMP quality systems and partnering with Global Quality team members and cross-functional partners to develop/enhance KPIs, enhance Veeva QMS Modules, ensure robust Veeva QMS records, and support inspection readiness. 

• Provide oversight of quality systems for R&D and Late Phase/Commercial GMP activities including Change Control, Quality Events, Deviations, Investigations, CAPA, and Product Quality Complaints
• Design, implement, and maintain product quality complaint handling (documentation, coordination, investigation, resolution, closeout) and investigation processes and procedures for R&D and commercial products in compliance with regulatory requirements (21 CFR 210, 211) and internal procedures
• Partner with Global Drug Safety to ensure that complaints associated with an Adverse Event (AE) or Serious Adverse Event (SAE) are reported timely to GDS in accordance with internal procedures
• Write/review internal/vendor Change Controls, Quality Events, Deviations, Investigations, CAPA, and Product Quality Complaints and ensure they are properly documented in Veeva and inspection ready
• Partner with internal stakeholders and vendors to drive on-time closure of complaint and QMS records  
• Support validation, implementation, and maintenance activities for the Veeva QMS & Complaint Modules
• Develop, implement, and maintain GMP Quality System and complaint metrics/KPIs to monitor performance and drive continuous improvement activities. Report metrics and trends to Senior Management for Management Review, QE & CAPA Board Meetings, internal audits, and other ad hoc meetings, as required. Escalate issues requiring immediate attention per procedure
• Escalate critical complaints, quality events, trends to senior management timely per procedure
• Gather complaint and QMS data to assist with Annual Product Reviews. Also support any potential stock recovery/recall, and/or field alert/field correction activities, if needed
• Participate in the qualification, onboarding, and product training of call center for handling of commercial product quality complaints
• Work with internal stakeholders to establish and maintain feedback systems and other post-market surveillance processes
• Participate in internal/vendor audits and health authority inspections as needed
• Support GMP quality systems by driving regulatory compliance in accordance with applicable regulations and business objectives
• Establish and maintain SOPs, work instructions, forms, templates, and other documents associated with Quality Systems and Product Quality Complaints
• Additional Quality projects and responsibilities may be assigned based on business needs of a growing organization

• 8+ years of relevant QA experience in pharmaceutical industry in QA or QC role supporting GMP Activities for Investigational Medicinal Products and/or Marketed Products
• Experience in the design, development, implementation, and maintenance of a product complaints management program for marketed products
• Technical writing experience; writing SOPs, investigations, performing root cause analysis, and identifying CAPAs
• Strong analytical problem solving and decision-making skills
• Experience participating in Health Authority Inspections
• Experience working in electronic quality management systems (Veeva or equivalent)
• 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
• 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 up to 20% domestic travel, occasional international travel may also be expected

• 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
• Ability to coordinate timelines with internal customers and vendors

• Bachelor’s degree in life science or engineering field

Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.