Senior Specialist, Clinical Quality Assurance

Job PostingOur Research & Development Division Quality Assurance (QA) is an independent organization that provides quality focus at each critical stage of the product development life cycle, including post approval marketing, to ensure high-quality, safe, and effective products, contributing to the company mission of improving and saving lives around the world. Our Research & Development Division QA Clinical Quality (CQ) provide independent assurance that our Company ensures the safety, rights, and well-being of participants, while complying with applicable global regulatory requirements through sound processes, procedures, and strategies for ensuring data integrity in our clinical trials.Primary Responsibilities:Leads their own specific tasks and responsibilities within a team, prioritizing time and effort towards important deliverables and producing high-quality workContributes to the overall goals of the team by excelling at their individual role and taking initiative to improve their own skillsInfluences, partners and collaborates with other colleagues within and outside their teamPrepares, conducts QA audits, generates audit reports, communicates results to the relevant QA management and external relevant stakeholders (e.g. Clinical Operations), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.Be able to analyze and leverage critical to quality factors to identify potential risks to prepare and perform risked-based auditsActivities may include GCP audits of investigator sites, suppliers, third party collaborations and due diligence activities.In alignment with risk assessments, supports the QAL in the identification of audit substrate for scheduling, as appropriate.Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL and TA Head.Interfaces and provides day-to-day support to applicable QA functional line to ensure appropriate quality oversight of assigned studies.Assesses compliance of clinical investigator sites, vendors, study activities, clinical study reports and submission documents, and Country Offices (COs) processes against ICH (International Conference of Harmonization), applicable government agency regulations/guidelines, as well as our Company's policies, procedures and industry standards.The QAS should have a comprehensive working knowledge of Quality Assurance, regulations and auditing. Develops and delivers awareness sessions with minimal supervision on various GCP and PV topics internally and externally.Promotes standardization of auditing approach within QA.Routinely suggests new audit techniques/aids in areas of technical expertise.Ensures the work climate/culture within QA, exemplifies our Company's Leadership behaviorsResponsibilities relative to the Auditor Resourcer include:Support, advance, and drive the Clinical Quality capacity planning and assignment of GCP auditsLead our Research & Development Division QA Clinical Quality audit planning processesImplement annual audit programs into the Veeva Vault QMS systemPerform routine QC checks and follow up with Clinical Quality and other QA functional groups on key parameters in the Veeva Vault QMS systemResolve scheduling conflicts for quarterly audit assignments to ensure Clinical Quality reaches its annual planned auditsCollaborate across our Research & Development Division QA to continuously improve business processes as it relates to the new systems and toolsCollaborate with our Research & Development Division IT organization on exploration of technologies to solve our Research & Development Division QA business needsCollaborate with our Research & Development Division Analytics & QA Analytics and Tech/System teams as needed on the continued evolution of data analytics and use of metricsUnderstand applicable regulations, technology, and processes to work effectively with our Research & Development Division QA functional areas and subject matter expertsSupport the project lead/project manager for activities, which may include (but are not limited to) the following:Drive the development and/or improvement of technology solutions related to document, audit, and quality issues managementDevelop and/or revise standard operating procedures as related to QA systems and supporting practicesParticipate in continuous process improvement initiatives as related to QA systems and supporting practicesAnalyzing and trending data from audits across our Research & Development DivisionSupport the development of best practices and resources related to current industry initiativesEducation:BS/BA degree or equivalent and/or experience in a relevant field, along with proficiency in the primary activities and essential skills required for this role.Requirements:Good Clinical Practice (GCP) experience required.3 years of GCP experience preferred.Good oral and communication skills.Good time management skills.Ability to work independently.Ability to travel up to 50% of time.Enterprise Leadership Skills:Ownership and Accountability - Taking ownership; setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks; self-imposing standards of excellence rather than having standards imposed.Execution Excellence - Taking prompt action to accomplish work goals, per compliance standards; taking action to achieve results beyond what is required; being proactive.Emotional Intelligence - Meeting the personal needs of individuals to build trust, encourage two-way communication, build allyship and strengthen relationships.Networking and Partnerships - Building partnerships; developing and leveraging relationships within and across work groups to achieve results.Coaching and Development- Building self-insight; demonstrating an awareness of own strengths and development needs as well as the impact of own behavior on others; modifying behavior based on self-awareness to improve impact.Talent Growth - Embracing continuous learning; actively identifying new areas for growth; regularly creating and taking advantage of learning opportunities; using newly gained knowledge and skills on the job and learning through their application.Diversity and Inclusion Valuing differences; working effectively with individuals of diverse cultures, interpersonal styles, perspectives, motivations or backgrounds; seeking out and including unique abilities, insights and ideas from a diverse mix of individuals.Required Skills:AccountabilityAdaptabilityAudits ComplianceBusiness ProcessesClinical DocumentationClinical Quality ManagementClinical Systems ImplementationClinical TrialsContinual Improvement ProcessData AnalysisData Quality ControlDetail-OrientedDeviation ManagementDocumentationsEmployee Training ProgramsGMP AuditingInterpersonal RelationshipsManufacturing ProcessesManufacturing Quality ControlProcess ImprovementsProduct DevelopmentProject ManagementQuality Assurance (QA)Quality Assurance SystemsPreferred Skills:The salary range for this role is $104,200.00 - $163,900.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits.