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Manager, Quality Systems
Job ID: 2020-2088
Type: Regular Full-Time
# of Openings: 1
Category: Quality - Dept
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
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
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
Supports the management of documents and records in the Quality
Vault, in collaboration with members of the Quality Assurance
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
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)
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.