Lead Quality Assurance, Technology (Remote)

About the position The Quality Assurance Manager at WCG is responsible for establishing and maintaining quality assurance standards and measures across the technology services organizations, which include Information Technology and Software Development. This role is crucial in ensuring that these standards comply with regulatory requirements and best practices. The Quality Assurance Manager will work closely with WCG leadership to achieve corporate and departmental compliance goals, ensuring that the Clinical Services Organization (CSO) remains compliant with WCG's Quality Management System and technology processes. In this position, the individual will engage in the continued development, maintenance, and enforcement of the CSO Quality Management System. They will manage and lead efforts regarding the identification, development, and maintenance of CSO quality goals, objectives, and process improvements. The Quality Assurance Manager will establish and enforce quality department standards, coach and train WCG staff on these standards, and engage with staff to author and revise internal technology standards, including IT and Software Development Policies and Standard Operating Procedures (SOPs). Additionally, the role involves leading the development of new processes or updates to existing processes, managing the acquisition and implementation of WCG systems, and serving as the subject matter expert in Computer System Validation strategy. The Quality Assurance Manager will also be responsible for managing investigations of Quality Events, conducting internal audits, and ensuring compliance with applicable regulations. This position requires a proactive approach to maintaining current knowledge of quality legislation and regulatory compliance best practices, as well as providing training and guidance to staff regarding compliance and interpretation of regulations.

Responsibilities

• Engage in the continued development, maintenance, and enforcement of the CSO Quality Management System.

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• Manage/lead efforts with regard to the identification, development and maintenance of CSO quality goals, objectives, and process improvements.

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• Establish and enforce CSO quality department standards.

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• Coach and train WCG staff on CSO quality department standards and best practices.

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• Engage with WCG staff to author and revise internal technology standards (i.e. IT and/or Software Development Policies, SOPs, et al).

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• Lead the development of new processes, or updates to existing, processes.

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• Lead the transition of processes for WCG acquisition companies into the WCG framework.

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• Ensure such standards are in conformity with applicable regulatory agency regulations and guidance.

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• Ensure such standards are made available to employees for training.

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• Manage the acquisition, implementation, and/or development, of WCG systems.

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• Serve as the subject matter expert with respect to the development of Computer System Validation strategy and management of its execution/implementation.

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• Manage the implementation, development, and change management of systems to ensure compliance with regulatory agency regulations and guidance.

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• Manage/lead the investigation of Quality Events/Corrective Actions Preventative Actions (CAPA), deviations, and notes to file (NTF).

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• Conduct internal audits to ensure compliance with applicable WCG processes and regulatory agency regulations.

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• Develop vendor audit plans, reports, collection of responses, and follow up.

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• Host external audits and inspections including communication with sponsor/agency, internal audit preparation activities, review of audit report, collection of responses, and follow-up on findings resolution.

Requirements

• Bachelor's degree or local equivalent in medicine, science, technology or equivalent degree/experience.

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• Minimum of seven (7) years' experience in a quality/regulatory compliance position, with a proven track record of success in leading/managing quality assurance projects/assignments, audits and resources.

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• A minimum of three (3) years' experience in establishing and monitoring compliance standards across a business unit including analysis and tracking.

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• A minimum of two (2) years supervising the work of others to complete key initiatives, projects.

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• Thorough knowledge of current regulatory (FDA & ICH) & GCP guidelines as they apply to clinical studies.

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• Demonstrated knowledge of 21 CFR Part 11 requirements and Computerized System Validation processes including SDLC.

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• Experience in leading Computerized System Validation efforts of systems used in Clinical Trials.

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• Strong organizational and planning skills.

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• Strong management skills with a proven record to influence and negotiate.

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• Effective communication (written and oral) skills, organization and interpersonal skills as well as the ability to interact with WCG staff, sponsors, and regulatory agencies as needed.

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• In-depth knowledge and understanding of drug development and the clinical trial process.

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• Highly developed problem solving skills and the ability to resolve difficult conflicts.

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• Ability to multitask and to work efficiently and independently.

Nice-to-haves

Benefits

• Comprehensive Benefits package - Health, Dental, Vision, Life Disability, 401k with match, and flexible spending accounts

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• Employee Assistance Programs and additional work/life resources

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• Referral Bonuses and Tuition Reimbursement

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• Paid time off including holidays, vacation, and sick time

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• Opportunities for career development with on-the-job training, certification assistance and continuing education reimbursement

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