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1+ months

Lead, Operations QA & Compliance - Remote

WIRB-Copernicus Group (WCG)
Work Remotely

General Information

Location: Princeton, NJ

Organization: WCG

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:
  • Bachelors 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:
  • 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, and resources.
  • A minimum of three (3) years experience in establishing and monitoring compliance standards across a business unit including analysis and tracking.
  • Prefer a minimum of two (2) years supervising the work of others to complete key initiatives and projects.
  • A satisfactory progression of auditing experience from support to execution an hosting, in a pharmaceutical company or Client Research Organization (CRO).
  • Thorough knowledge of current regulatory and GCP guidelines as they apply to document management practices in clinical trials and WCG services/products.
  • Minimum of one (1) year experience in ISO certification is desired.
  • Will conduct presentations on behalf of WCG. Strong presentation skills required.
  • Strong MS Office skills required.
  • 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 personnel, clients, and regulatory agencies as needed.
  • In-depth knowledge and understanding of the clinical trial process.
  • Highly developed problem-solving skills and the ability to resolve difficult 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 CSO Quality Management System.
  • Manage/lead efforts in the identification, development and maintenance of CSO quality goals, objectives, and process improvements.
  • Establish and enforce CSO quality department objectives.
  • 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 applicants' 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 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 HIPPA.
  • 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/troubleshoot issues reported by personnel.
  • Manage, lead and 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 of 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 QA & 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 response and follow up on findings resolution.
  • Maintain current knowledge with respect to quality legislation and regulatory compliance best practice.
  • Provide training and guidance regarding compliance and interpretation of regulations.
  • Ability to work independently across functional resources with minimal oversight.
  • 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.
  • Must be able to work additional hours as needed for special projects and audits.


TRAVEL REQUIREMENTS: 20%

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Categories

Posted: 2022-05-20 Expires: 2022-07-07

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Lead, Operations QA & Compliance - Remote

WIRB-Copernicus Group (WCG)

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