- Partner with Safety Assessment & Research Operations to understand development programs and related risk factors to drive audit planning & scheduling. Attend project-team meetings and provide quality input as needed
- Develop risk-based audit strategy to support pre-clinical programs
- Plan and conduct internal, external, routine and for-cause GLP audits worldwide, including audits in preparation for regulatory inspections. Ensure timely responses to audit findings and implement corrective actions as necessary
- Guide functional teams through the deviation/CAPA process to ensure robust investigation, timely action, and meaningful improvements to process
- Perform Quality Control of documents and data as requested by project teams
- Using quality management system tools, analyze audit findings and deviation trends to drive continuous improvement
- Liaise with external contractors conducting audits on behalf of Cerevel. This may include providing information about company processes, known quality issues, audit scoping expectations, and/or guidance on use of the audit system
- Train staff on regulatory requirements, quality management processes and procedures, and inspection readiness
- Prepare for and participate in regulatory inspections and compliance audits related to GLP activities
- Conduct risk assessments to identify potential areas of non-compliance and implement risk mitigation strategies
- Collaborate with teams to establish and maintain a culture of continuous improvement in quality assurance
- Stay current with updates to GLP regulations and communicate changes to stakeholders
- Collaborate with cross-functional teams to establish and enhance quality systems that support GLP compliance
- Represent Cerevel in external industry groups, forums, conferences, and/or professional associations
- Lead and/or participate in projects and/or departmental initiatives or other duties as assigned
- Proven experience in quality assurance role within the pharmaceutical or biotechnology industry
- 5 + years of Quality experience required, including direct GLP audit experience across various audit types
- Knowledge of GLP regulations, guidelines, and industry best practices
- Strong analytical and problem-solving skills
- Detail-oriented with a high-level of accuracy and integrity
- Strong project management, interpersonal, and communication skills
- Skilled user of Microsoft Office applications such as with Word, Excel, PowerPoint, and Outlook
- Ability to travel as needed to support quality and inspection activities
- Experience with the principles of risk analysis and issue management (corrective and preventive action processes). Experience performing risk assessments and successfully implementing quality plans
- Excellent judgment and interpersonal skills, consensus and relationship building
- Excellent communication and presentation skills
- A high degree of autonomy; takes accountability for work
- Very organized and efficient; delivers high-quality work
- B.S/B.A degree in science, nursing, or related field
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Senior Specialist, Global Quality Management, Good Laboratory Practices - Boston, United States - Cerevel Therapeutics
Description
Company OverviewCerevel 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.
The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions.
Role Summary:
The Sr.
Specialist, Quality Management (GLP) applies working knowledge in pharmaceutical research and quality assurance to provide consultation to pre-clinical development teams and performs independent quality audits of pre-clinical vendors and internal processes and systems.
In addition, this role is important in ensuring effective corrective and preventive actions are in place to ensure continuing quality of development programs.
Key Responsibilities
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.
