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Manager, Quality Systems

Company: Radius Health
Location: Waltham
Posted on: October 12, 2020

Job Description:

Radius Health

Radius Health is an equal opportunity employer. EEO/Disabled Individuals/Veterans. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HRconnect@radiuspharm.com. Click here to navigate to the EEO is the Law poster. Click here to navigate Radius Health's Pay Transparency Policy.

Manager, Quality Systems

US-MA-Waltham

Job ID: 2020-2088

Type: Regular Full-Time

# of Openings: 1

Category: Quality - Dept

Overview

The Manager, Quality Systems is responsible for developing and maintaining Radius Health Quality Systems in compliance with GxP regulatory requirements. This individual partners cross-functionally to identify and implement improvements to Quality Systems and associated Veeva applications to meet business needs.

Responsibilities

Plans and supports continuous improvement initiatives for Quality Systems and associated Veeva applications for Document Control, Training, Deviations, CAPA, Change Control, Product Complaint, Audit, and Supplier/Vendor Qualification processes.

Serves as the Business Owner and subject matter expert for the Veeva Quality Vault (QualityDocs and QMS applications) and AdobeSign, which includes the following responsibilities: Gathers business requirements for changes and enhancements from users.

Evaluates new features in system updates/releases and discusses recommendations with users.

Assesses priority and risk of potential changes and enhancements, and develops implementation strategy in collaboration with Information Technology (IT), QA Validation and the software vendor.

Develops IT change controls, reviews and approves associated validation documentation, and supports change implementation as required by plans and procedures.

Maintains Quality System procedures, work instructions, and training materials in compliance with GxP regulations.

Develops training materials and facilitates training for Quality System procedures and associated QualityDocs and QMS applications.

Supports the management of documents and records in the Quality Vault, in collaboration with members of the Quality Assurance team.

Establishes quality metrics and develops reporting tools within Veeva for trending and reporting metrics.

Participates in internal and external audits related to Quality Systems, as needed.

Supports regulatory inspection readiness activities, as needed.

Qualifications

Bachelor’s degree and 5-10 years’ relevant pharmaceutical industry experience with 5+ years’ experience directly supporting GxP Quality Management Systems.

Experience implementing and maintaining electronic Quality Management System; experience with Veeva QualityVault (QualityDocs and QMS applications) and Compliance Wire preferred.

Strong administrative skills, including Microsoft Office Suite (PowerPoint, Word, Excel, and Visio).

Ability to work independently to solve problems.

Excellent communication, teamwork, and collaboration skills.

Thorough understanding of US, European, and International (ICH) regulatory requirements.

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. Frequent 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. While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

PM18

PI124640679

Keywords: Radius Health, Waltham , Manager, Quality Systems, Other , Waltham, Massachusetts

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