- As a member of the R&D Quality Leadership Team, contribute to the development of risk-based quality strategy, processes and tools, and provide expertise and leadership in the areas of GCP/GVP/GLP compliance of clinical development activities & operations.
- Proactively identifying regulatory risks and process gaps through monitoring of available data and Key performance/Quality Indicators (KP(Q)Is) and development of risk-mitigation strategies/plans to mitigate risk.
- Participating in the review of study related metrics (i.e; protocol deviation, etc.) as part of the Quality Management Risk (QMR) approach to identify gaps, trends, and the need for process improvements
- Assessing Inspection Readiness of clinical development activities and operations and develop improvement strategies.
- Assisting R&D Quality GCP, GVP and GLP Inspection Management Teams and cross-functional compliance functions, in developing/adjusting adequate Inspection Readiness (IR) Plans and Strategies, based on review of available data/metrics.
- Assisting R&D Quality GCP/GVP/GLP audit functions in developing/adjusting the audit scope/strategy, based on review of data/metrics.
- Assisting R&D Quality GCP/GVP/GLP Internal Audit Team in selection of processes/system for audit and defining scope for selected system/process audits.
- Providing oversight, initiating, leading and participate in cross-functional clinical development Quality by Design initiatives and other quality improvement initiatives, in collaboration with cross functional compliance functions.
- Providing oversight and leading improvement initiatives for key R&D Quality systems, processes and procedures.
- Initiating/assisting/collaborating (in) the development of cross-functional Quality Improvement (QI) Quality, and Quality Management Risk plans.
- Initiating/assisting/collaborating (in) the development of Quality Improvement (QI) initiatives to ensure data integrity.
- Proactively involving/leading and collaborate with other Quality and cross-functional functions in the identification of training needs
- Promoting continuous improvement by partnering with key stakeholders to identify trends in quality events and ensure risk-based solutions are implemented in a timely manner and escalated to senior leadership.
- Defining metrics and measures for R&D Quality to drive assessment and continuous improvement.
- Participating and representing R&D Quality in meetings and discussions, as required.
- Overseeing Quality activities related to FDA, EMA and ROW regulations across therapeutic areas and provide GCP guidance for all phases of drug development
- Supporting regulatory intelligence impact assessments on BeiGene processes an procedures.
- Writing, reviewing, and approving Quality - documents (e.g., SOP's).
- Participate in budget forecasting, planning, and tracking; monitor and maintain activities to stay within budget (as required)
- Provide coaching and mentoring of junior staff with training / orientation / qualification of new Quality staff
- Identify and escalate potential serious GCP non-compliances within R&D Quality management and relevant cross functional management
- Implement existing Quality Strategy and divisional and department-specific guidelines in all areas for which the job holder is responsible.
- Expert knowledge of GCPs, particularly FDA, EMA and ICH requirements.
- Strong global knowledge and understanding of international regulations applicable to the conduct of clinical trials and pharmacovigilance and GLP operations
- Ability to resolve complex problems where analysis of situations or data requires an in-depth evaluation of various factors
- Superb attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment.
- Exercise sound and balanced judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, plans and protocols for compliance
- Proven ability in setting strategy for and driving quality process improvement initiatives
- Strong leadership experience and mentoring skills
- Other duties as assigned
- PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint, Project)
- History of working with Veeva QMS System is preferred
- Excellent verbal and written communication skills
- Ability to effectively collaborate in a dynamic environment
- Quality
- Clinical Operations
- Pharmacovigilance
- Clinical Business Operations
- Biometrics
- Medical Monitors
- Regulatory Affairs
- Interacts with all levels of BeiGene
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Director R&D Quality Excellence - Emeryville, United States - BeiGene
Description
General Description:
The Director GCP/GLP/GVP Systems & Data Integrity, is responsible for implementing and maintaining a balanced, proactive, and phase appropriate approach to GCP, GVP and GLP Quality Assurance.
This position will be primarily responsible for ensuring research and development, pharmacovigilance and GLP activities are conducted in accordance with applicable regulatory requirements, guidelines, laws and internally established standards and practices.
Essential Functions of the Job:
Manage and oversee R&D Quality activities which include, but are not limited to:
Additional Qualifications:
Supervisory Responsibilities:
This position will include close collaboration with R&D Quality Leadership Team, all R&D Quality staff and other Quality Functions.
Additionally, it will include managing staff:
coaching and mentoring of junior staff with training/orientation/qualification and development plan for new R&D Quality staff when required. Therefore, it is required to have strong leadership experience and mentoring skills.
Computer Skills
:
Other Qualifications:
Education Required:
10+ years' experience, bachelor's degree, preferably in science or combination of education and equivalent work experience. 7+ years with higher level education.
Communication & Interpersonal Skills
Significant Contacts
Travel:
May require up to 20% travel
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
