Location: Princeton, NJ
Organization: WCG
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 who perform clinical trials. WCG is proud to serve the individuals on the frontlines of science and medicine, and the organizations that strive 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 that 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: $86,900 to $100,000
Your Role: The Lead, Operations Quality and Assurance is Responsible for establishing and maintaining quality assurance standards and measures across WCG services organizations 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 the Quality Management System and business processes.
What We Are Looking For in a Successful Lead, Operations Quality and Assurance:
- Bachelor’s degree in a relevant discipline required, or equivalent combination of education and experience
- Certifications for quality professionals through the Society for Quality Assurance, American Society for Quality or comparable certifications are desirable
- Minimum of five (5) 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 in the Pharmaceutical/Biotech industry
- 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 and GCP guidelines as they apply to clinical studies and WCG services/products
- Minimum of one (1) year experience in ISO certification is desired
- 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, clients, 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 work efficiently and independently
What You Will Be Doing:
- Engage in the continued development, maintenance, and enforcement of the CSO Quality Management System
- Manage/lead efforts regarding 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, revise and implement internal standards and associated documents
- Lead the development of new processes, or updates to existing, processes
- 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 integration, implementation, and/or development, of WCG businesses
- Serve as the subject matter expert with respect to the harmonization of processes and procedures
- Lead the transition of computerized systems for WCG acquisition companies into the WCG framework, as applicable
- Manage the implementation, development, and release of controlled documents to ensure same is performed in line with industry standards, and regulatory agency regulations and guidance, including but not limited to, GxP, 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 follow applicable WCG process, industry standards and 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 processes and procedures
- 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, Operations Compliance
- Conduct external vendor qualification audits to ensure that vendor standards and performance follow 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 client/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
Travel: 20%
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