Gcp Operational Quality Senior Manager (Contract)

• Serves as the Quality Lead for assigned clinical programs providing GCP compliance interpretation, consultation, and other support services necessary to maintain and/or improve the quality of Vertex research to ensure the protection of subjects' safety, rights, and well-being as well as the integrity and credibility of data generated.
• Engages with study teams and functions for proactive inspection readiness across assigned programs.
• Liaise with Vertex clinical functions and external parties including CROs, Vendors and investigator sites to promote high level of quality and consistency across and within programs.
• Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to Good Clinical Practice (GCP).
• Contributes to the development and implementation of continuous quality improvement initiatives.
• Develops risk-based audit plans for assigned programs, ensures audits are conducted in accordance with the plan, reviews audit reports, evaluates responses and CAPA plans in accordance with company standards and policies.
• Provides QA review of protocols and participates on Operational Review Boards to identify operational risks and collaborates with study team in development of risk mitigation strategies.
• Manages and/or leads domestic and international audits for Clinical Investigators, to ensure compliance to ICH GCP, applicable regulations, and company standards.
• May serve as GCP Quality Management System representative
• For assigned programs/ studies, leads quality issue investigations, root cause analysis and CAPA development and assist study teams in implementing corrective and preventive actions in support of sustainable compliance.
• Provides inspection support as necessary for Regulatory Agency inspections held at Vertex facilities or Clinical Investigator sites.

• Participates in collaborative review of impacted SOP/WI

• May participate on process improvement initiatives

• Develop and maintain QA to QA relationships with GCP Vendors to conform to quality agreements, and participates in applicable Vendor Joint Operating Committees, as needed.

• Proficient in managing complex projects, achieving goals and deadlines.
• Typically requires 6 years of experience or the equivalent combination of education and experience
• In-depth knowledge of ICH GCP R2 and applicable global regulations and guidance for clinical development (e.g., FDA regulations, EU Regulations and Directives, MHRA Statutory Instruments, etc.)
• Ability to understand and translate customer needs, bringing a new perspective to existing quality management solutions
• Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers.
• In-depth knowledge of Event Management processes and requirements, including investigation, root cause analysis, CAPA plan development and Effectiveness Checks.
• Proficient in using Microsoft Office applications is an asset (MS Word, MS Excel, MS PowerPoint, Visio)
• Ability to work independently with minimal guidance, organizing and prioritizing work effectively for timeliness, accuracy and quality
• Strong experience with key performance indicators, metrics analysis, and monitoring/trending of quality and compliance metrics
• Strong experience with all phases of clinical trial development involving drugs.

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at [email protected]. Please include the job title in the subject of your email.