The T echnology 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.
Manage efforts to identify, develop and maintain quality goals,
objectives, and process improvements.
Coach and train staff on CSO quality department standards and
Lead the transition of processes for WCG acquisition companies
into the WCG framework.
Manage the acquisition, implementation, and/or development, of
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
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.
Bachelors degree or local equivalent in medicine, science,
technology or equivalent degree and years of 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
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%
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.
WCG is proud to be an equal opportunity employer Qualified
applicants will receive consideration for employment without regard
to race, color, national origin, religion, sex, sexual orientation,
gender identity, age, marital status, disability, veteran status or
any other status protected by law.
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