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1+ months

Manager, Technology Quality Assurance

WIRB-Copernicus Group (WCG)
Hamilton, NJ 08609

General Information

Location: Hamilton Township, NJ

Organization: WIRB-Copernicus Group Inc

Job Type: Full Time

Description and Requirements

The Manager, Technology Quality Assurance will be responsible for managing quality assurance resources and establishing team goals and objectives in alignment with corporate quality goals.  The person in this role will also help establish and maintain quality assurance standards and measurements across WCGs technology services organizations.  This position is responsible for working alongside WCG leadership to achieve corporate and departmental compliance goals as well as ensuring the WCG organization (all businesses) remain compliant with the Quality Management System and technology processes.  This position can be located at either our Plymouth Meeting PA or Hamilton NJ location.

ESSENTIAL DUTIES/RESPONSIBILITIES: 

  • Engage in the continued development, maintenance, and enforcement of the Quality Management System throughout the organization.

  • Engage with Company staff to author and revise internal technology standards (i.e. IT and/or Software Development Policies, SOPs, et al). 

  • Manage the integration, implementation, and/or development, of new WCG businesses and/or systems.

  • Manage/lead the investigation of Quality Events/Corrective Actions Preventative Actions (CAPA), deviations, and notes to file (NTF).

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

  • Maintain the compliance schedule of external vendor qualification to ensure that vendors remain in compliance with applicable WCG process.

  • Host external audits and inspections including communication with sponsor/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.

EDUCATION REQUIREMENTS:

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

CERTIFICATIONS:

  • Certifications for quality professionals through the Society for Quality Assurance and the 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, audits, and resources as well as monitoring and tracking compliance standards.

  • Three  (3) years experience in a management/leadership position responsible for hiring, developing and training  a team of direct reports including establishing team goals and objectives.

  • 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.

  • Experience in leading Computerized System Validation efforts of systems used in Clinical Trials.

  • In-depth knowledge and understanding of drug development and the clinical trial process.

  • Strong management skills with a proven record to influence and negotiation.

  • Highly developed problem solving skills and the ability to resolve difficult conflicts.

SUPERVISORY RESPONSIBILITIES: Responsibility for the management of quality assurance team members including direction, coordination, and evaluation of the assigned team and staff. 

TRAVEL REQUIREMENTS: 20%

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.


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Posted: 2019-08-27 Expires: 2019-10-31

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Manager, Technology Quality Assurance

WIRB-Copernicus Group (WCG)
Hamilton, NJ 08609

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