General Information

Location: Princeton, NJ, Remote

Organization: Research Solutions

Job Type: Full Time - Regular

Description and Requirements

ABOUT WCG: WCG’s clinical solutions are built on a foundation of best-in-class clinical services companies. We deliver transformational solutions that stimulate growth, foster compliance, and maximize efficiency for those performing clinical trials. WCG is proud to serve individuals on the frontlines of science and medicine, and the organizations striving to develop new products and therapies to improve the quality of human health. It is our role to empower them to accelerate advancement, while ensuring the risks of progress never outweigh the value of human life.

WHY WE LOVE WCG: At WCG, our employees are our most valuable asset and as with all our assets, we invest in them with an eye toward future success. We provide each eligible employee with a comprehensive set of benefits designed to protect their personal and financial health and to help them make the most of their future.
  • Comprehensive Benefits package - Health, Dental, Vision, Life Disability, 401k with match, and flexible spending accounts
  • Employee Assistance Programs and additional work/life resources
  • Referral Bonuses and Tuition Reimbursement
  • Paid time off including holidays, vacation, and sick time
  • Opportunities for career development with on-the-job training, certification assistance and continuing education reimbursement

Expected annual base salary range: $78,210 to $120,000 (range is expected, specific compensation offered may vary based on factors including, but not limited to, the candidate's relevant knowledge, training, skills, work location, and/or experience
GPS Level: P4

SUMMARY OF POSITION: 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:
  • 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.
  • A minimum of three (3) years’ experience in establishing and monitoring compliance standards across a business unit including analysis and tracking.
  • A minimum of two (2) years supervising the work of others to complete key initiatives, projects.
  • 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: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required.
  • Engage in the continued development, maintenance, and enforcement of the CSO Quality Management System.
  • Manage/lead efforts with regard to the identification, 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).
  • Lead the development of new processes, or updates to existing, processes.
  • Lead the transition of processes for WCG acquisition companies into the WCG framework.
  • Ensure such standards are in conformity with applicable regulatory agency regulations and guidance.
  • Ensure such standards are made available to employees for training.
  • Manage the acquisition, implementation, and/or development, of WCG systems.
  • 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 development and review of Validation deliverables related to the implementation, and/or development, of WCG systems.
  • Lead the transition of computerized systems for WCG acquisition companies into the WCG framework, as applicable.
  • 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.
  • 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.
  • Manage/lead the conduct internal audits/periodic review of company policies and procedures.
  • Manage/lead the conduct internal audits/periodic review of WCG systems.
  • 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.
  • 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.
  • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
  • Attendance and punctuality are essential functions of the position.
SUPERVISORY RESPONSIBILITIES: None

TRAVEL REQUIREMENTS: 10-15%

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