United States onlyThe Sr. Manager, Quality Management (GLP) is an important liaison with the Safety Assessment, Clinical Pharmacology, and DMPK teams. Specifically, the Sr. Manager, 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
- 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
- Provide guidance to employees, external contractors, and development partners on tropics related to GLP compliance and to facilitate identification and resolution of GLP-related issues and concerns
- Manage 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
- Play a key role in the coordination of GLP 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
Required Qualifications
- Proven experience in quality assurance role within the pharmaceutical or biotechnology industry
- Direct GLP audit experience across various audit types (5-10 years)
- Thorough knowledge of GLP regulations, guidelines, and industry best practices
- Experience with the principles of risk analysis and issue management (corrective and preventive action processes). Ability to perform risk assessments and successfully implement quality plans
- Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams and vendors
- Excellent analytical, problem-solving, and time management skills
- Detail-oriented with a high-level of accuracy and integrity
- Ability to work independently toward effective solutions
- 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
Desired Qualifications
- 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
Education
- B.S/B.A degree in science, nursing, or related field
