Quality Management Director (GCP)
Quality Management Director (GCP)
Full-time Boston-based position responsible for the development and execution of the Cerevel GCP Audit Plan, including preparing for and managing regulatory inspections related to GCP and GVP. In addition, this role is responsible for leading the Global Quality operations, which are inclusive of GxP SOP Management, CAPA and Deviation Management, Quality Event/Serious compliance breach issue support, SOP and Quality-related training and Document Management. Provide guidance and quality expertise to the business in the interpretation of clinical development regulations, Good Clinical Practice (GCPs) guidelines, regulatory actions, and other regulatory developments. Responsible for overseeing a pool of experienced contract auditors in the GCP, GPV and CSV space. Will host any 3rd party audits and health-authority inspections.
This role will work closely with the GMP Quality function to ensure seamless Quality support to the Cerevel business. Reports to the Vice President of Quality Management.
- Develops the GCP/GVP risk-based Global Audit Plan as per Cerevel process
- Oversees the conduct of internal, external, routine and for-cause GCP and GVP audits worldwide, including audits in preparation for regulatory inspections. Assesses whether audit and response are acceptable, identifies critical issues, moves expeditiously to act when appropriate.
- Responsible for CAPA and Deviation Management: Ensures that audit and/or regulatory authority inspection findings/observations are assessed and understood by the responsible business function in a timely manner, and when applicable result in a meaningful improvement in process
- Interfaces with regulatory/compliance government officials as necessary and hosts any GCP/GVP on-site inspections pursuant to company policy
- Responsible for global SOP Management: Ensures that the business has a Quality Management System which supports access to effective standard operating procedures.
- Oversees the compliance of the Quality Management System in collaboration with GMP colleagues
- Responsible for providing effective SOP and GCP related training to employees and external contractors, inclusive of clinical site staff when applicable
- Responsible for managing assigned aspects of the budget and supporting risk-mitigation efforts led by the business
- Ensures that the QM function supports employees, external contractors, investigators, clinical development partners, and regulatory inspectors in addressing all aspects related to clinical trial development, to identify and resolve GCP related issues or concerns
- Directs the establishment and maintenance of Global Quality Management operating procedures, auditing tools, and auditing techniques. Ensures that external contractors are adhering to the regulations and protocols that are established for Cerevel QM
- Supports regulation and guideline interpretation for clinical development and GCP issues to Cerevel multi-functional study teams
- Ensures the onboarding and ongoing training of Quality Management personnel (employees and contractors)
- Effectively presents information to clinical teams and business functions, so mistakes are not repeated.
- Contributes to Global Quality goals, projects and initiatives
- Responsible for developing and delivering GCP training, personally and/or through a 3rd party, to clinical trial sites and investigators
- Lead and/or participate in departmental initiatives as assigned
- Performs other duties as assigned
- Requires strong knowledge of regulatory inspections with experience hosting
- Solid understanding of the regulatory climate related to GCP (inclusive of Pharmacovigilance/GVP and CSV)
- Expertise of scientific and clinical concepts within global clinical programs
- Excellent knowledge of GCP/regulatory compliance activities necessary for day-to-day operations of clinical trial management and study site management
- Strong understanding of the R&D business; ability to partner with the business functions in order to enable high quality outcomes
- Strong project management, interpersonal, and communication skills
- Experience in managing contract service providers
- 5 years of managerial and supervisory experience
- Strong computer skills with Word, Excel, PowerPoint, and Outlook
- 10 years in the pharmaceutical industry, with exposure to multiple therapeutic areas and different phases of clinical trials; CNS strongly preferred
- Desire to work in a fast-pace, dynamic environment
- Excellent communication and presentation skills
- Team player; experienced at developing talent
- A high degree of autonomy; takes accountability for work
- Very organized and efficient; delivers high-quality work
Bachelor of Science in a life science major required; Master’s and/or Ph.D. preferred
An attractive compensation package commensurate with this management role will be provided.
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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