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19 days old

Quality Auditor & Technology Compliance Lead

WIRB-Copernicus Group (WCG)
Plymouth Meeting, PA 19462

General Information

Location: Plymouth Meeting, PA

Organization: ePharmaSolutions LLC

Job Type: Full Time - Regular

Description and Requirements

The Technology QA & Compliance Lead will be 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 WCGs Quality Management System and technology processes. 

Essential Duties/Responsibilities: 

  • Manage efforts to identify, develop and maintain quality goals, objectives, and process improvements.

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

  • Lead the transition of processes for WCG acquisition companies into the WCG framework.

  • 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.

  • 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).

  • Manage/lead the conduct internal audits to ensure internal standards and staff performance are in compliance with applicable process, regulatory agency regulation and guidance.

  • 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.

Education Requirements:

  • Bachelors degree or local equivalent in medicine, science, technology or equivalent degree and years of experience.

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, 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.

  • Strong organizational and planning skills.

  • 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.

Supervisory Responsibilities:  None 

Travel Requirements: 5% - 10%

About us:

The pioneer of independent ethical review, WIRB-Copernicus Group (WCG), continues to drive ingenuity in the clinical research space. Today, WCGs solutions are built upon the foundation of ethical review, but have grown to include a suite of complementary services and technologies that expand the capabilities of the modern research professional. WCG delivers transformational solutions that stimulate growth, foster compliance, and maximize efficiency for those who perform clinical trials.

Categories

Posted: 2020-09-08 Expires: 2020-10-17

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Quality Auditor & Technology Compliance Lead

WIRB-Copernicus Group (WCG)
Plymouth Meeting, PA 19462

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