Manager, GCS Risk Management Lead
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
The GCS Quality Management Group instills concepts of Risk Management and Inspection Readiness through Global Clinical Supply to ensure that clinical trial project work is conducted to internal and external standards and can withstand Regulatory Inspection.
The GCS Risk Management role works as a close liaison with Clinical Supply Teams (CST) and PharmSci Quality Assurance colleagues to facilitate line discussions and ensure quality state of identification, mitigation and maintenance of risks. The position includes interaction with a diverse range of internal stakeholders, potentially including representatives from across the Global Product Development (GPD) organization and Medicinal Sciences.
This includes close liaison with Clinical Supply Teams (CST) and PharmSci Quality Assurance colleagues to trigger and facilitate line discussions to ensure state of program inspection readiness at all times.
The role requires understanding of GCP and GMP to support robust risk management relevant to Investigational product, including clinical trial processes and systems within GCS. Strong organization and communication skills, both written and oral, are critical.
The role requires understanding of GCS functional lines and interdependencies to identify and estimate the appropriate risks to clinical trials. It is also important to understand the different internal and external factors that can affect its performance.
Risk Management Role: Proactively ensure GCS risk tools are triggered, deployed, maintained and prioritized for the entirety of a clinical program, example GCS risk register and Formal/Informal Quality Risk Management (QRM) risk assessment.
- Develop and utilize improved risk and predictive analysis to identify and manage risk to prevent occurrence of repeat issues.
- Use of systems and visualization tools (i.e., Spotfire), to evaluate quality information, identify common risks, trends and communicate findings.
- Generate trends, share appropriately and drive to understand to mitigate frequent risks across programs
- Review and share common Therapeutic Area risks including those surfaced by study team in study team risk log
- Ensuring compliance with applicable SOPs and Business processes spanning Medicinal Sciences and Global Product Development (GPD) as required.
- May periodically review/evaluate and propose process or training enhancements
- Appropriately escalate concerns to Head of GCS Quality Management and PharmSci QA related to timelines, engagement, and quality.
- Work across GCS functional lines and QA to manage and deliver responsibilities
- Use of data applications to surface, highlight, manage and share information to improve quality across GCS
- Support technological enhancements
- Support GCS Quality Governance boards or teams as needed
- Support trending and monitoring in efforts to ensure that the conduct of clinical trials complies with stringent scientific and ethical standards.
- May be required to support product quality investigations and Provide oversight to the timely closeout and effective investigation of clinical supplies, CAPA effectiveness, change control, trending and metrics
- A minimum of a BA or BS is required, advanced degree in relevant field desirable.
- Minimum 5 years of pharmaceutical experience with solid experience in clinical studies, investigational supplies, supply chain, GMP/GCP Quality, risk and issue management
- Technical proficiency, including skills in use of common desktop tools (MS Word, MS Excel, MS Project, Visio); Office365 and SharePoint; tools for analysis and graphing and reporting (Spotfire).
- Ability to progress work activities with oversight
- Knowledge of clinical trial processes and relationships GCP requirements and applicable SOPs and regulations are required
- Risk management skills including defining risks and mitigation efforts
- Project management, administrative, and technical capabilities
- Strong and effective verbal and written communication skills
- Attention to detail
- Risk, quality or compliance experience preferred
- Background in Life Sciences or higher degree preferred
- Strong organizational skills and ability to prioritize multiple projects and meet targeted deliverables and deadlines
- Ability to adapt to changing situations and work well under pressure
- Experience in supporting continuous improvement projects
- Proven ability to function autonomously in a matrix model and in a team environment.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Travel will be minimal.
May include domestic and international travel to GCS sites.
May periodically require working across US, EU, Asia hours to support activity and/or engagement with global colleagues.
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