Suvoda is a global clinical trial technology company shaping digital experiences that enable clinical trialsponsor and site professionals to take full command over the inherent logistical complexity behindmission-critical and time-sensitive patient interactions in life-sustaining studies for therapeutic areas suchas oncology, central nervous system, and rare disease.
Supporting clinical trials means supporting unique experiments that are inherently complex, high-stakes, and dynamic. It is imperative that Suvoda staff working with clients, end-users, or the systems that clientand end-users interact with understand the clinical trial industry, regulations, Suvoda’s software productsand processes, and especially the specificities of the unique trial in question before taking any actionsthey may alter the data of the system in question.
We are open to fully remote candidates across Romania for this role.
Responsibilities:
- Manages andfacilitatesall stages of the Quality Event Management process, including but not limited to,conducting investigations, assessing risk/impact, conducting trendanalyses, definingand tracking corrective and preventive actions and associated effectiveness checks.
- Conducts Quality Event Investigations by facilitating and completing root cause analyses: working internally with cross-functional teams to collect and analyze relevant data, utilizing and applying RCA tools (such as flowcharts, fish bone diagrams, 5-Why's analysis, etc.) and ensuring that investigations are conducted in accordance with a GCP-regulated environment. Applies CAPA disciplines to develop effective corrective and preventive action plans.
- Performs quality event trend reviews andfacilitatesanalyses, escalating observations whendeemedwarranted byQMSprocess.
- Produces client-facing documents/communications, such as Quality Event Investigation Reports; adapting highly technical investigation details for a non-technical audience and communicating investigation progress updates to stakeholders when needed.
- Conducts risk assessments andfacilitatesimpact analyses in response to Quality Event Investigations.
- Attendsweekly Issue Management Team meetings. Prepares slides for the meetings, takes notes during meetings, and follows up on actions from the meeting, asrequired.
- Prepares and evaluates datapertaining toquality eventsinpreparation of audits and inresponse to audit findings, workingcross functionally with teams to implement process improvementsas needed.
- Develops andmaintainskey performance indicators (KPIs) and calculates performance based on data from available sources to support the continuous improvement of the quality management system.
- Assiststeams to develop new processes in the form of SOPs, Work Instructions, Guidelines, Forms,Templatesand knowledgebase articles. Likewise, performs reviews and revisions of current processes in the form of SOPs, Work Instructions, Guidelines, Forms,Templatesand knowledgebase articles to ensure continuous improvement of the Quality Management System.
- Creates internal reports for stakeholders that provide insight and valueregardingproduct and process performanceand/or the status of Quality Event Investigation activitiesusing a combination of Excel and PowerPoint.
Requirements:
- Bachelor’s degree in science-related field preferred
- At least 3 years ofrelevantexperiencein aGxPcompliance and/or quality-related rolepreferred
- High-achieving personality
- Desire to learn, grow, and develop
- Strong work ethic and sense of ownership
- Highly analytical with fine attention to detail
- Proactive attitude
- Strong time management and organization skills
- Ability to practice risk-based judgement
- Excellent oral and written communication skills and technical writing capabilities; Proficient in English.
- Knowledge of Process Improvement techniques preferred
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As set forth in Suvoda’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.
If you are based in California, we encourage you to read this important information for California residents linked here.
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