General Information

Location: Washington, DC

Organization: Statistics Collaborative

Job Type: Full Time - Regular

Description and Requirements

JOB SUMMARY: 

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.


VACCINATION REQUIREMENT:

To be considered for U.S.-based positions unless currently employed by WCG, where permitted by applicable law (including any applicable reasonable accommodation, medical or religious exemption), candidates must have received or be willing to receive the COVID-19 vaccine by start date.


EDUCATON REQUIREMENTS:

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

CERTIFICATIONS/LICENSE/REGISTRATION REQUIREMENTS:

  • Certifications for quality professionals through the Society for Quality Assurance, American Society for Quality or comparable certifications are desirable.

QUALIFICATIONS/EXPERIENCE:

  • Ability to work efficiently and independently.
  • Highly developed problem-solving skills and the ability to resolve difficult conflicts.
  • In-depth knowledge and understanding of drug development and the clinical trial process.
  • 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.
  • Strong management skills with a proven record to influence and negotiate.
  • Strong organizational and planning skills.
  • Minimum of one (1) year experience in ISO certification is required.
  • Thorough knowledge of current regulatory and GCP guidelines as they apply to clinical studies and WCG services/products.
  • A satisfactory progression of auditing experience from support to execution and hosting, in a pharmaceutical company or Clinical Research Organization (CRO).
  • A minimum of two (2) years supervising the work of others to complete key initiatives, projects.
  • A minimum of three (3) years’ experience in establishing and monitoring compliance standards across a business unit including analysis and tracking.
  • 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.

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 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 REQUIREMENTS: 20%

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