PSG Global Solutions
Significant Quality Event Lead
PSG Global Solutions, Groton, Connecticut, us, 06349
At Real we're always looking for new and ambitious people to help deliver exceptional service levels, change the lives of the candidates we represent and partner with some of the world's best pharmaceutical, biotechnology and medical companies.As specialists in recognising talent we pride ourselves on not just finding the best people for our client partners but on our ability to spot the best and brightest talent to work for us. We are also renowned for providing training and long-term career opportunities to help our employees be the best they can be, so they can continue to deliver the expertise Real has become famous for.Relationships are at the heart of everything we do and ensure that our clients and candidates continue to work with us again and again. This ethos is also what shapes how we work as a business. We encourage and reward knowledge sharing and have various support networks and international forums to enable our employees to keep up-to-date with changes happening across their industries and share local insight to deliver true global perspectives.Job Description
Purpose:To work with and on behalf of Clinical Development Quality within DevOps, performing management of Significant Quality Events.Significant Quality Event Lead:The individual responsible for the formation and leading of the Significant Quality Event Team and coordinating all activities related to initiating immediate action, conducting Investigation/RCA, developing corrective and preventive actions, as needed, and documenting case activities within the appropriate database. Conduct broader impacts across the Pfizer portfolio to share learnings with other impacted study teams.This position will include:Interaction with a diverse range of stakeholders from varying internal linesAbility to be an effective project manager, lead Significant Quality Event Teams and/or Investigation/RCA Teams, and progress delivery of actionsUnderstanding/knowledge of GCP, clinical trial processes and systems, CAPA, quality issues, regulatory requirements, quality management, Root Cause Analysis, inspection readinessOrganizational Relationships:Reports to GCP Compliance ManagerPrimary Duties:Significant Quality Event managementForming Significant Quality Event TeamArranging meetings with Significant Quality Event Team, RCA Team, and/or BusinessProcess Owner within specified timelinesDocumenting meeting outcomes in meeting minutes or otherFacilitating Root Cause Analysis (or other types of investigation) and producing outputsEnsuring appropriate actions are assigned and progressed to completionUpdating the appropriate databaseEnsuring all documentation is filed appropriatelyQualifications
Training & Education:Degree in one of the disciplines related to drug development or business.Advanced/in-depth knowledge which may include quality audit, quality management, inspection readiness, quality and compliance assessments, CAPA Management, continuous improvement methodology, root cause analysis.Knowledge of clinical trials operational processes and systems which may include study management, data management, reporting, and project management.Prior Experience preferred:Understanding of clinical trialsAbility to work successfully with internal and external partners; strong interpersonal skills and ability to build and maintain excellent working relationships across lines in a matrix organizationExperience of leading global initiatives or project teams. Appreciation of diverse needs of different regulatory requirements of different sites and countries.Knowledge of quality requirements across a range of different countriesStrong influencing skills with ability to influence a broad range of global stakeholders.Excellent communication skills adaptable to meet the needs of diverse stakeholder groups, internal and external.Record of achievement and delivery for personal and team goals.Ability to balance and prioritize a diverse and demanding workload.Works independently and proactively sets own work agenda with minimum guidanceQuality related experience including familiarity with:ICH GCP, and Regulatory obligationsQuality and compliance management, QCProject/initiative coordination and management skillsAbility to translate quality/compliance strategic imperatives into executable tactical plansDetail/Comments Specific skills:Experienced in Quality areas: e.g. audit, inspection, compliance, CAPA management, and inspection readiness fieldsCI/RCA skill and experienceKnowledge of ICH GCP and regulations in order to assess GCP situations and appropriate actionsAbility to lead cross-line global initiatives or root cause analysis for quality related process improvementActs independently. Most projects are self-initiated. Leverages knowledge from others related to overall objectives, strategy, critical issues, and policy matters.Having the personal and organizational confidence to communicate difficult messages promptly and in a suitable manner so that appropriate actions can be taken.Encourages contributions by generating commitment to and achievement of business objectives; serves as an advocate for othersLobbies key internal and external stakeholders to ensure successLooks for opportunities for collaboration and acts upon themWork with others to ensure close collaboration and supportExercises foresight and judgment utilizing comprehensive breadth of knowledge and prior work experienceMakes strategic use of quality/compliance data to monitor & raise performanceRespectfully challenges practices, decisions or ideas to uphold integrity and ethical standardsResponds to changing situations and others’ ideas that differ from own positively and constructivelyExperience:3-5 years’ experienceAdditional Information
All your information will be kept confidential according to EEO guidelines.
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Purpose:To work with and on behalf of Clinical Development Quality within DevOps, performing management of Significant Quality Events.Significant Quality Event Lead:The individual responsible for the formation and leading of the Significant Quality Event Team and coordinating all activities related to initiating immediate action, conducting Investigation/RCA, developing corrective and preventive actions, as needed, and documenting case activities within the appropriate database. Conduct broader impacts across the Pfizer portfolio to share learnings with other impacted study teams.This position will include:Interaction with a diverse range of stakeholders from varying internal linesAbility to be an effective project manager, lead Significant Quality Event Teams and/or Investigation/RCA Teams, and progress delivery of actionsUnderstanding/knowledge of GCP, clinical trial processes and systems, CAPA, quality issues, regulatory requirements, quality management, Root Cause Analysis, inspection readinessOrganizational Relationships:Reports to GCP Compliance ManagerPrimary Duties:Significant Quality Event managementForming Significant Quality Event TeamArranging meetings with Significant Quality Event Team, RCA Team, and/or BusinessProcess Owner within specified timelinesDocumenting meeting outcomes in meeting minutes or otherFacilitating Root Cause Analysis (or other types of investigation) and producing outputsEnsuring appropriate actions are assigned and progressed to completionUpdating the appropriate databaseEnsuring all documentation is filed appropriatelyQualifications
Training & Education:Degree in one of the disciplines related to drug development or business.Advanced/in-depth knowledge which may include quality audit, quality management, inspection readiness, quality and compliance assessments, CAPA Management, continuous improvement methodology, root cause analysis.Knowledge of clinical trials operational processes and systems which may include study management, data management, reporting, and project management.Prior Experience preferred:Understanding of clinical trialsAbility to work successfully with internal and external partners; strong interpersonal skills and ability to build and maintain excellent working relationships across lines in a matrix organizationExperience of leading global initiatives or project teams. Appreciation of diverse needs of different regulatory requirements of different sites and countries.Knowledge of quality requirements across a range of different countriesStrong influencing skills with ability to influence a broad range of global stakeholders.Excellent communication skills adaptable to meet the needs of diverse stakeholder groups, internal and external.Record of achievement and delivery for personal and team goals.Ability to balance and prioritize a diverse and demanding workload.Works independently and proactively sets own work agenda with minimum guidanceQuality related experience including familiarity with:ICH GCP, and Regulatory obligationsQuality and compliance management, QCProject/initiative coordination and management skillsAbility to translate quality/compliance strategic imperatives into executable tactical plansDetail/Comments Specific skills:Experienced in Quality areas: e.g. audit, inspection, compliance, CAPA management, and inspection readiness fieldsCI/RCA skill and experienceKnowledge of ICH GCP and regulations in order to assess GCP situations and appropriate actionsAbility to lead cross-line global initiatives or root cause analysis for quality related process improvementActs independently. Most projects are self-initiated. Leverages knowledge from others related to overall objectives, strategy, critical issues, and policy matters.Having the personal and organizational confidence to communicate difficult messages promptly and in a suitable manner so that appropriate actions can be taken.Encourages contributions by generating commitment to and achievement of business objectives; serves as an advocate for othersLobbies key internal and external stakeholders to ensure successLooks for opportunities for collaboration and acts upon themWork with others to ensure close collaboration and supportExercises foresight and judgment utilizing comprehensive breadth of knowledge and prior work experienceMakes strategic use of quality/compliance data to monitor & raise performanceRespectfully challenges practices, decisions or ideas to uphold integrity and ethical standardsResponds to changing situations and others’ ideas that differ from own positively and constructivelyExperience:3-5 years’ experienceAdditional Information
All your information will be kept confidential according to EEO guidelines.
#J-18808-Ljbffr