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, GLP/GMP Vendor Quality Management develops, implements, and maintains processes, quality systems, and tools required to manage and monitor outsourced GLP/GMP activities and GMP Vendors that are utilized in the manufacturing, packaging, labeling, testing, warehousing, and distributing of finished pharmaceutical products and investigational medicinal products.

Key Responsibilities

Lead development, implementation, and maintenance of the Cerevel GLP/GMP Vendor Management Program

Write, in partnership with Global Quality Management, the cross-functional/Global Quality departmental policy, procedures and supporting documents used to perform GLP/GMP Vendor selection, qualification, management, monitoring, and performance

Create Quality Agreement templates. Ensure that Quality Agreements are written, approved and in-place for external GMP vendors

Ensure that all GLP/GMP vendors are appropriately qualified

Develop annual GLP/GMP audit plans, ensure all required audits are scheduled and conducted, audit documentation is accurate and complete, observations are sent to vendors, audit responses are received from vendors and are acceptable, and audits are closed out in a timely manner in Veeva

Create, review, and/or approve GLP/GMP Vendor Organization and Audit Records in Veeva

Supervise Cerevel contract auditors who lead and conduct audits of GLP/GMP vendors on behalf of Cerevel to ensure compliance with Cerevel requirements as well as applicable regulatory requirements

Lead and conduct audits of GLP/GMP vendors; ensure compliance with Cerevel requirements as well as applicable regulatory requirements

Develop and report key performance indicators, metrics, and compliance status of GLP/GMP Vendors to Global Quality senior management

Present vendor management data at Management Reviews, Internal Audits and Regulatory Inspections

Additional Quality projects and responsibilities may be assigned based on business needs of a growing organization

Required Qualifications

8+ years of relevant Supplier Quality experience (managing/auditing of suppliers) in pharmaceutical industry

Experience in the development, implementation, and maintenance of a GLP/GMP Vendor Management Program

Experience participating in Health Authority Inspections

Experience working in electronic quality management systems (Veeva or equivalent)

Ability to partner and build relationships 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

Desired Qualifications

ASQ Certified Quality Auditor certification, or equivalent.

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

Education

Bachelor’s degree in life science or engineering field

Company COVID-19 Vaccination Policy

The Company requires all employees to be vaccinated against COVID-19, including to have received a booster dose of a COVID-19 vaccine if eligible to receive one. In connection with your onboarding process, all new employees will need to provide documentary evidence of vaccination. The Company is an equal opportunity employer and will provide reasonable accommodations to those individuals who are unable to be vaccinated consistent with federal, state and local law

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.