Responsible for establishing and maintaining quality assurance standards and measures across WCG technology services organizations (Information Technology, Software Development) and ensuring such standards comply with regulatory requirements and best practice. This position is responsible for working alongside WCG leadership to achieve corporate and departmental compliance goals as well as ensuring the CSO organization remains compliant with WCG's Quality Management System and technology processes.

EDUCATION REQUIREMENTS:

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

QUALIFICATIONS/EXPERIENCE:

• Three (3) to five seven (75) years' experience in a quality/regulatory compliance position, with a proven track record of increasing responsibility in leading/managing quality assurance projects/assignments.




• Two years' experience in establishing and monitoring compliance standards across a business unit including analysis and tracking.




• A satisfactory progression of auditing experience from support to execution and hosting, in a pharmaceutical company or Clinical Research Organization (CRO).




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




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




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




• Strong organizational and planning skills.




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




• 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.




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




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




• Ability to multitask and to work efficiently and independently.

ESSENTIAL DUTIES/RESPONSIBILITIES:

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


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


• Establish and enforce CSO quality department standards.


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



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




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




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




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




• Manage the implementation, development, and change management of systems to ensure same is performed in line with regulatory agency regulations and guidance, including but not limited to, GxP, 21 CFR Part 11/Annex 11, GDPR, and HIPAA.




• Serve as the subject matter expert with respect to the development of Computer System Validation strategy and management of its execution/implementation. This may include the review of Validation deliverables, related to the implementation, and/or development, of WCG systems.




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




• Ensure proper investigation of such events is performed, and documentation maintained.




• Manage/lead the conduct internal audits to ensure internal standards and staff performance are in compliance with applicable WCG process, regulatory agency regulation and guidance.




• Identify compliance gaps and provide support and suggestions for remediation. Report status of the quality levels of staff, systems and production activities to the VP, IT Compliance.




• Manage/lead the conduct internal audits/periodic review of WCG systems.




• Manage/lead the conduct internal audits/periodic review of company policies and procedures.




• Conduct external vendor qualification audits to ensure that vendor standards and performance are in compliance with applicable WCG process, regulatory agency regulation and guidance.




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




• 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.




• Maintain current knowledge with respect to quality legislation and regulatory compliance best practice.




• Provide training and guidance to staff regarding compliance and interpretation of regulations.

TRAVEL REQUIREMENTS:10-15%