Job Details

Quality Assurance Clinical Quality Auditor

Our 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) provides 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 work
• Contributes to the overall goals of the team by excelling at their individual role and taking initiative to improve their own skills
• Influences, partners and collaborates with other colleagues within and outside their team
• Prepares, 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 audits
• Activities 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 behaviors

Responsibilities relative to the Auditor Resourcer include:

• Support, advance, and drive the Clinical Quality capacity planning and assignment of GCP audits
• Lead our Research & Development Division QA Clinical Quality audit planning processes
• Implement annual audit programs into the Veeva Vault QMS system
• Perform routine QC checks and follow up with Clinical Quality and other QA functional groups on key parameters in the Veeva Vault QMS system
• Resolve scheduling conflicts for quarterly audit assignments to ensure Clinical Quality reaches its annual planned audits
• Collaborate across our Research & Development Division QA to continuously improve business processes as it relates to the new systems and tools
• Collaborate with our Research & Development Division IT organization on exploration of technologies to solve our Research & Development Division QA business needs
• Collaborate with our Research & Development Division Analytics & QA Analytics and Tech/System teams as needed on the continued evolution of data analytics and use of metrics
• Understand applicable regulations, technology, and processes to work effectively with our Research & Development Division QA functional areas and subject matter experts
• Support 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 management
• Develop and/or revise standard operating procedures as related to QA systems and supporting practices
• Participate in continuous process improvement initiatives as related to QA systems and supporting practices
• Analyzing and trending data from audits across our Research & Development Division
• Support the development of best practices and resources related to current industry initiatives

Education:

• 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:

• Accountability
• Adaptability
• Audits Compliance
• Business Processes
• Clinical Documentation
• Clinical Quality Management
• Clinical Systems Implementation
• Clinical Trials
• Continual Improvement Process
• Data Analysis
• Data Quality Control
• Detail-Oriented
• Deviation Management
• Documentations
• Employee Training Programs
• GMP Auditing
• Interpersonal Relationships
• Manufacturing Processes
• Manufacturing Quality Control
• Process Improvements
• Product Development
• Project Management
• Quality Assurance (QA)
• Quality Assurance Systems

U.S. Hybrid Work Model:

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

Salary:

The salary range for this role is $104,200.00 - $163,900.00. 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