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.
The Senior Manager, Global Product Quality will be responsible for both operational and compliance management of GMP and GLP QA activities at Cerevel to support the manufacture, packaging, testing, and supply of materials for use in toxicology studies, clinical trials, and commercial operations. This individual will provide technical quality expertise and phase-appropriate compliance guidance to cross-functional teams internally and externally, in the development and implementation of cGMP compliant quality systems, to ensure product quality, data integrity, and most importantly, patient safety at Cerevel.
In addition, this role will be responsible for overseeing a network of global vendors (e.g. CROs/CDMOs/CMOs), and will work closely with the GxP Quality Management functions to support the development and inspection readiness of Global Quality Management Systems, which may include but not limited to, GxP document management and training, deviation and CAPA management, change management, product quality complaints, risk management, vendor management, internal/external audits and inspection readiness, etc.
- 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 clinical products and 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 clinical trials and 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. Responsible for 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 compliant 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
- 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 clinical and/or 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
- 2+ years of supplier quality experience managing GMP/GLP Vendors
- Previous experience working in a clinical and/or 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
- 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
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.
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