Manager, Quality Systems at Radius Health in Waltham, MA

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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.

US-MA-Waltham

Job ID 2019-1978
# of Openings 1
Category Quality - Dept

Overview

The Manager, Quality Systems is responsible for managing the overall technology applications that help support a quality compliance environment across Radius Health's GXP (Good Clinical / Manufacturing / Laboratory / Pharmacovigilance / Distribution, etc. Practices) regulated activities.

Responsibilities

  • Serves as the business owner for Quality Vault, Radius's application for managing controlled documents related to manufacturing, pharmacovigilance, QA procedural documents, QA oversight documents, and Quality Management System (QMS) records, which includes the following responsibilities:
    • Gather business requirements for changes and enhancements to the Veeva QualityDocs EDMS (Electronic Document Management System) and Veeva QMS, which includes Deviations, Audits, GMP Change Controls, Product Complaints, CAPAs, and Supplier/Vendor Qualification records management.
    • Develop, review, and approve change controls and implementation of changes in collaboration with Information Technology (IT), QA Validation and the software vendor
    • Facilitate appropriate Validation documentation and User Acceptance Testing in collaboration with Information Technology (IT) and QA Validation
    • Align document management practices, system changes and enhancements across Vaults in collaboration with other Radius Vault EDMS business owners (eTMF Vault, RIM/Submissions Vault and PromoMats Vault) where appropriate
    • Plan and develop instructor-led, computer-based, and self-paced training for the Quality Vault Docs and QMS applications, including overseeing and/or executing on the development of materials, delivery of topics and facilitation of sessions
    • Supervises administrative staff in scheduling training sessions, preparation of materials and equipment.
  • Supports the management of documents and records in the Quality Systems, including migration of legacy documents and records, in collaboration with members of the Quality Assurance team and stakeholders in Technical Operations, Clinical and Pharmacovigilance fucntions
  • Generates quality metrics related to training and controlled procedures for management review and continuous improvement initiatives.
  • Supports health authority inspections, as needed.


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.

Qualifications

  • Bachelor's degree and 5-10 years' relevant pharmaceutical industry experience with 5+ years' experience directly supporting GxP Quality Management Systems.
  • Experience with Veeva QualityVault (QualityDocs and QMS applications) preferred.
  • Strong administrative skills, including Microsoft Office Suite (PowerPoint, Word, Excel, and Visio).
  • Ability to work independently to solve problems.

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