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Senior Associate, Operations QA & Compliance (Remote)

General Information

Location: Princeton, NJ, Remote

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 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 to help 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

• Flexible PTO

• Volunteer Time Off to benefit the community

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

Expected annual base salary range: $62,460 to $97,000

GPS level: P3

JOB SUMMARY : The Senior Associate, Operations QA & Compliance 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 CTS organization remains compliant with WCG’s Quality Management System and business processes.

EDUCATION REQUIREMENTS : Bachelor’s degree in a relevant discipline required, or equivalent combination of education and experience.

QUALIFICATIONS/EXPERIENCE :

• Three to five (3-5) years’ experience in a quality/regulatory compliance position, with a proven track record of increasing responsibility in leading/managing quality assurance projects/assignments.

• Two (2) 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 and GCP guidelines as they apply to clinical studies and WCG services/products.

• 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, and clients as needed.

• Knowledge and understanding of drug development and the clinical trial process.

• Ability to problem solve and engage in the resolution of conflicts.

• Ability 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 CTS Quality Management System.

• Manage/lead efforts regarding the development and maintenance of CTS quality goals, objectives, and process improvements.

• Establish and enforce CTS quality department standards.

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

• Engage with WCG staff to author, revise and implement internal standards and associated documents.

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

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

• Assist in the integration, implementation, and/or development of WCG businesses.

• Assist in the harmonization of processes and procedures.

• Assist in the development, implementation and release of controlled documents to ensure same is performed in line with industry standards, and regulatory agency regulations and guidances, including but not limited to, GxP, GDPR, and HIPAA.

• Complete all internal training assignments in a timely manner.

• Manage 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.

• Lead in the conduct of internal audits to ensure internal standards and staff performance follow applicable WCG process, regulatory agency regulations and guidances.

• Lead/assist in the conduct internal audits/periodic review of WCG policies, processes and procedures.

• Identify compliance gaps and provide support and suggestions for remediation.

• Draft audit reports as applicable.

• 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.

• Support the hosting of external audits and assist inspections including internal audit preparation activities, audit 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 REQUIREMENTS :

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PHYSICAL DEMANDS : The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to perform sedentary work which includes sitting for long periods of time and occasionally required to lift 25lbs (11.3 kg). Further guidance on physical activities, requirements, visual acuity, and working conditions is available in HCM.

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WCG is proud to be an equal opportunity employer – Qualified applicants will receive consideration for employment without regard to race, color, national origin or ancestry, religion or creed, sex, sexual orientation, gender identity, age, marital status, disability, genetic information, citizenship, veteran status, reprisal or any other legally recognized basis or status protected by federal, state or local law.