Job Summary:

• Providing support to the DMS to identify, define and implement the Ochre Health Clinical Quality Improvement Plan.
• Defining, documenting and implementing Ochre Health’s core Nursing workflows
• Undertaking risk and capability assessments for new clinical Nursing services
• Define the Nurse Leadership Model.
• Support the Operations team to ensure relevant commercial outcomes are achieved.
• Define the National CDM Service Delivery Model
• Identify appropriate clinical and commercial outcomes.
• Define the Nurse Education Plan and implement a training calendar, including associated communications and Nursing engagement strategy.
• Ensure that all Medical Centres meet the RACGP and AGPAL accreditation standards.
• Work closely with the Operations team to directly support Nurse engagement, conflict resolution and performance plans.

Skills on Resume:

• Quality Improvement (Hard Skills)
• Process Documentation (Hard Skills)
• Risk Assessment (Hard Skills)
• Leadership Development (Soft Skills)
• Operations Support (Soft Skills)
• Service Modeling (Hard Skills)
• Educational Design (Hard Skills)
• Conflict Resolution (Soft Skills)

Job Summary:

• Be responsible for Installation Quality Management
• Manage a team of Quality Auditors
• Implement Quality Management System related to the project in accordance with Operators Quality Management System, business processes, and project requirements
• Monitor site deployment Quality Key Performance Indicators (KPIs) in consultation with Project Management Team
• Ensure that all stakeholders installation vendors / Quality engineers, compile the correct Quality Guidelines/Practices
• Guide/Train installation vendors/Quality engineers on quality requirements & ensure compliance throughout the project
• Identify Quality issues/deviations & guide the teams for correction
• Identify installation vendors Quality performance/Quality issues, guide vendors on Quality improvement & monitor the same for closure
• Monitor critical operations during system tests about quality
• Identify Quality lessons learned from the mistakes & guide the teams not to repeat the same in the future.

Skills on Resume:

• Quality Management (Hard Skills)
• Team Leadership (Soft Skills)
• System Implementation (Hard Skills)
• KPI Monitoring (Hard Skills)
• Stakeholder Coordination (Soft Skills)
• Training Compliance (Soft Skills)
• Issue Identification (Hard Skills)
• Performance Monitoring (Hard Skills)

Job Summary:

• Creation, review and updating of all Clinical Department Standard Operating Procedures (SOPs) in accordance with Sanaria Quality Systems.
• Lead, conduct and/or assist in all internal clinical quality audits, including internal adherence to SOPs, computer system validation, etc.
• Conduct, assist and/or oversee external audits (e.g. audits of external vendors or clinical sites, etc.)
• Work with the Clinical Department and contract auditors as necessary and assist in the drafting of audit plans, confirmation letters and agendas, etc.
• Ensure adherence to the applicable US CFR, ICH-GCP and EU Directive quality standards
• Identify potential systemic gaps and non-compliance, and coordinate the response with the appropriate stakeholder to ensure timely remediation.
• Facilitate and review the Clinical Department’s response process tointernal and external audits and inspections. 
• Review the responses and actions performed to address findings through the CAPA process. 
• Perform program specific root cause analysis of compliance issues and provide the appropriate metrics for tracking and trending.
• Work closely with the Clinical Department and Quality Systems to ensure/coordinate appropriate and complete resolution of findings/non-compliant issues, quality investigations, etc. in a timely manner, including approval of corrective action and preventative action (CAPA) plans
• Ensure adequate and up-to-date training and oversight of the Clinical Department members as it relates to GCP and SOP training, etc.
• Provide Quality Assurance (QA) of trial master files (TMFs) prior to TMF closeout and archiving.
• Provide QA review of clinical trial related documents as necessary, including clinical Protocols, Amendments, Informed Consent Forms, Clinical Study Reports, etc.

Skills on Resume:

• SOP Management (Hard Skills)
• Quality Audits (Hard Skills)
• External Auditing (Hard Skills)
• Audit Coordination (Soft Skills)
• Compliance Assurance (Hard Skills)
• Gap Identification (Hard Skills)
• CAPA Management (Hard Skills)
• Document QA (Hard Skills)

Job Summary:

• Provide QA review of clinical data including clinical immunology data and clinical reports in compliance with Sanaria SOPs.
• Draft Quality Management Plans and Risk Management Plans for individual clinical trials per ICH GCP Section 5.0.
• Evaluate clinical trial adherence according to each individual Quality Management Plan and Risk Management Plan.
• Assist with inspection readiness, and regulatory inspections 
• Assist with developing training presentations on quality assurance for investigational sites and for the Sanaria clinical team.
• Assist with clinical site quality management as needed, may include review of site CAPAs, deviation reporting compliance, etc.
• Assist with clinical site qualifications, particularly in respect to the quality systems in place.
• Participate in departmental and cross-departmental meetings and provide guidance to Clinical Department staff based on interpretation of current regulations to ensure best practices including risk-based management.
• Perform a global review of study data individually and across trials
• Investigate inconsistencies within and across individual databases and reconcile any inconsistent findings.

Skills on Resume:

• Clinical QA Review (Hard Skills)
• Plan Drafting (Hard Skills)
• Trial Evaluation (Hard Skills)
• Inspection Readiness (Hard Skills)
• Training Development (Soft Skills)
• Site Quality Management (Hard Skills)
• Site Qualifications (Hard Skills)
• Data Reconciliation (Hard Skills)

Job Summary:

• Provides Quality oversight and support for clinical development programs.
• Supports Clinical Quality Management System through the development, implementation and management of Quality Assurance procedures, processes and systems in accordance with E6 (R2).
• Executes on and/or provides oversight of quality monitoring and assurance of clinical trial execution of sponsored protocols.
• Executes on and/or provides oversight of clinical investigator audits, documentation audits and other study-specific or process audits.
• Engages with study teams and functions for proactive inspection readiness across all clinical programs.
• Conducts external and internal audits to assess compliance with GCP requirements, investigational plans and company standards for clinical trial-related activities.
• Communicates audit findings to audit stakeholders ensuring understanding as well as collaborating with auditees to develop Corrective and Preventive Action Plans (CAPAs), addressing root causes.
• Tracks, reviews, approves, and assesses the efficiency of CAPAs.
• Reviews and approves package insert labeling for generic and proprietary products in consultation with Clinical Development and Regulatory.
• Develops relevant training materials and conducts training.
• Assists with the preparation, coordination, and management of regulatory agency inspections.
• Monitors regulatory and industry trends/actions and reports regularly to Quality Assurance management.
• Interfaces with Clinical Development and Regulatory colleagues
• Collaborates with additional internal departments and external Contract Research Organizations.

Skills on Resume:

• Quality Oversight (Hard Skills)
• QA System Support (Hard Skills)
• Clinical Auditing (Hard Skills)
• Inspection Readiness (Hard Skills)
• CAPA Management (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Training Development (Soft Skills)
• Stakeholder Collaboration (Soft Skills)

Job Summary:

• Contribute to the development of local QMS (including GCP compliant process development) for managing local Clinical trial quality assurance in accordance with internal procedures
• Coordinate and contribute to the development of risk based GCP supplier audit and compliance strategy
• Develop, maintain and lead the supplier audit management plan in accordance with internal procedures
• Lead supplier and individual clinical study audit(s) (internal and external including clinical site(s)) in accordance with internal procedures
• Support the clinical operations team in supplier governance and oversight procedure
• Provide independent quality and compliance oversight for GCP suppliers, including but not limited to coordinating the development and execution of Quality Agreements, attending Governance meetings etc
• Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to senior management
• Ensure audit reports (both external and internal process audits) and corrective actions are developed and completed, escalated when required, within timelines mandated in internal procedures
• Assisting root cause identification, conducting gap analysis and implementation of corrective action plan (CAPA)
• Generate metrics and develop reports on GCP supplier quality performance
• Liaise with internal Takeda stakeholders, including the clinical supplies and regulatory teams, and external business partners to provide guidance and support pertaining to compliance with GCP and supplier quality oversight initiatives
• Collaborate with Quality Compliance and Systems team to identify and mitigate supplier related quality and compliance issues
• Escalate critical problems and recommend appropriate solutions to management for immediate and long-term resolution
• Ensure compliance with internal training and documentation procedures
• Participate in GCP health authority inspections 

Skills on Resume:

• QMS Development (Hard Skills)
• Audit Coordination (Hard Skills)
• Supplier Oversight (Hard Skills)
• Compliance Oversight (Hard Skills)
• Risk Assessment (Hard Skills)
• CAPA Implementation (Hard Skills)
• Stakeholder Liaison (Soft Skills)
• Quality Collaboration (Soft Skills)

Job Summary:

• Partners with peers and business stakeholders to develop strategic roadmap for electronic application platforms supporting the Clinical and Quality business functions.
• Deploys, Manages and Configures Clinical and Quality applications, as needed, to meet business needs.
• Provides leadership and subject matter expertise on Clinical and Quality application projects to ensure successful delivery outcomes.
• Identifies and partners with external service providers to deliver solutions and services.
• Responsible for developing, interpreting, reviewing, validating, documenting and maintaining functional requirements.
• Recruits, supervises and trains staff. 
• Plans, schedules, allocates and prioritizes workload to meet operating requirements and evaluates performance ensuring requirements are met.
• Ensures team members understand departmental objectives, specifications, deliverables, timelines and tasks.
• Monitor, assess, and ensure compliance of Clinical and Quality Applications with internal IT general controls and external regulatory requirements.
• Develops and implements policies, procedures and guidelines to ensure the quality of data and effective use of Quality and Clinical applications.
• Coordinates GXP system validation, where applicable, and maintains requisite documentation.
• Maintains an awareness of new technologies, trends and developments in order to improve service and create efficiencies within the department. 
• Keeps up-to-date with relevant professional literature and participates in seminars and training workshops 

Skills on Resume:

• Strategic Roadmapping (Hard Skills)
• Application Deployment (Hard Skills)
• Project Leadership (Soft Skills)
• Vendor Partnership (Soft Skills)
• Requirements Management (Hard Skills)
• Team Supervision (Soft Skills)
• Compliance Monitoring (Hard Skills)
• Technology Awareness (Hard Skills)

Job Summary:

• Provide overall governance for quality management systems, policies, and procedures, linking the organization together and providing the backbone for continual improvement.
• Lead the development of a dynamic quality management team that is fully integrated into all aspects of the manufacturing value chain (design, industrialization, customer delivery and satisfaction). 
• Set targets, nurture, coach, and develop skills and performance.
• Collect, organize and manage data from the manufacturing scope, developing systems and procedures that are agile and effective in protecting the company’s top priority – customer satisfaction.
• Drive product and operating compliance.
• Lead the company through ISO9001 and ISO14001 certifications, and cultural acceptance of working according to the quality manual.
• Work closely with finance teams to secure investment in quality management capabilities, and understand and continually reduce the costs of non-quality.
• Support the Collaborative Contracting Team by providing professional advice on clinical quality standards and services that impact the provision of services to patients.
• Support the team in the delivery of a diverse range of quality assurance measures that will include chairing meetings, producing notes, and taking actions on key quality measures.
• Assist in the development of robust incident reporting processes and investigations.
• Provide clinical guidance and support the development of local policies and guidance to be reflected in providers' contracts.
• Act as the NHS Arden and GEM CSU's Quality lead in negotiations and on-going monitoring of Quality Requirements and Commissioning for Quality and Innovation (CQUIN) inclusions in the NHS Standard Contracts for provider services commissioned by customer CCG's.

Skills on Resume:

• Quality Governance (Hard Skills)
• Team Development (Soft Skills)
• Data Management (Hard Skills)
• Compliance Leadership (Hard Skills)
• ISO Certifications (Hard Skills)
• Financial Collaboration (Soft Skills)
• Quality Assurance Support (Hard Skills)
• Clinical Guidance (Hard Skills)