Manager, GCP QA

Radius Health

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Manager, GCP QA

US-PA-Wayne | US-MA-Waltham

Job ID: 2020-2112
Type: Regular Full-Time
# of Openings: 1
Category: Quality – Dept

Overview

Radius is a science-driven biopharmaceutical company focused on developing new therapeutics for patients with osteoporosis as well as other serious endocrine-mediated diseases.

This role provides Quality Assurance oversight of Radius-sponsored clinical trials to ensure compliance with study protocols, regulatory requirements, Radius SOPs, and industry best practices.

Responsibilities

Own the compliance and inspection-readiness of assigned clinical trials.

Proactively provide GCP QA support to assigned clinical study teams based on analysis and interpretation of GCP regulations/guidance documents to assure compliance of clinical studies with regulatory authority expectations.
Provide oversight of clinical studies and the vendors involved in execution of clinical studies.

Review, provide input to, and approve documents related to clinical studies, including Protocols, Informed Consent Forms, Pharmacy Manuals, IRT specifications, EDC/eCRF system documentation, Protocol Deviations.
Perform independent electronic Trial Master File (eTMF) reviews and audits against regulatory and Radius standards to evaluate inspection readiness of study eTMFs.
Determine the need for documentation of Deviations, Corrective Actions and Preventive Actions, (CAPAs), and Notes to File to ensure satisfactory documentation of the execution of clinical trials.
Identify, investigate, and document Deviations that occur during the execution of clinical studies.

Manage GCP Audits of CROs, vendors, investigator sites, systems, and processes related to clinical study execution.
Implement GCP compliant procedures and operations to ensure a robust quality management system for the conduct of clinical studies.
Provide training, mentoring, and direction to clinical study team members, GCP QA personnel, and GxP QA personnel.
Develop, measure and report quality metrics to drive consistent quality standards throughout the organization.

Assist with the organization, preparation, coordination, and documentation of regulatory inspections.

Qualifications

Bachelor’s degree in a scientific discipline required
5-8 years of experience in the pharmaceutical/biotechnology industry, with at least 3 years in a GCP Quality Assurance position
Advanced knowledge of ICH E6(R2) Good Clinical Practice
Experience auditing CROs, vendors, investigator sites, and Trial Master Files

Strong computer and organizational skills
Excellent communication (oral and written) and attention to detail
Ability to work independently and as part of a team, comfortable working in combination with individuals in other departments across the organization
Flexible and adaptable in a changing environment

Work Environment:
The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Approximately 10% travel required.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

PM18

PI125883917