Radius Health, Inc.

Associate Director, Quality Management Systems

US-MA-Waltham
1 month ago
Job ID
2017-1640
# of Openings
1
Category
Quality

Overview

 

We are Radius Health! A science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases.

 

The Associate Director, Quality Management Systems is responsible for managing the overall system of controlled procedures, training and supporting technology applications to maintain a quality compliance environment across Radius Health’s GXP (Good Manufacturing/Clinical/Pharmacovigilance/Distribution/etc. Practices) regulated activities.

Responsibilities

  • Serves as the business owner for Quality Vault, Radius’s application for managing controlled documents and the Quality Management System (QMS) records including:
    • Working with stakeholders to gather business requirements for changes and enhancements to the Veeva QualityDocs EDMS and Veeva QMS (i.e. Deviations, CAPAs, Audits, GMP Change Control, Product Complaints, etc.) applications
    • Working with other Vault business owners (eTMF, RIM/Submissions, PromoMats) to align document management practices, system changes and enhancements across Vaultswhere appropriate
    • Interfacing with Information Technology (IT), QA Validation and vendors to develop, review, and approve change controls
    • Working with Systems Quality Assuranceto facilitate appropriate Validation documentation and User Acceptance Testing
    • Implementation of changes

 

  • Leads lifecycle management of controlled procedures, including development, content review, revision, finalization, periodic review, and retirement; supervises staff who perform administrative oversight of process.
  • Oversees regular quality control checks of the controlled process lifecycle.
  • Leads and facilitates the development of appropriate Standard Operating Procedures, forms, templates, and job aids for GXP regulated activities.,
  • Serves as a Subject Matter Expert (SME) from Quality Assurance for ComplianceWire, Radius’s Learning Management System, including
    • Working with the Business Owner and other stakeholders to gather business requirements for change controls
    • Reviewing and approving change controls
    • Participating in and/or providing appropriate resources for conducting User Acceptance Testing
    • Working with the Learning and Development team to align processes for use of LMS across organizations providing training

 

  • Works with functional leads across the organization to plan role-based training curricula for Quality Assurance topics and oversees implementation and changes to curricula in LMS.
  • Works with Quality Assurance Leads to plan and develop instructor-led, computer-based, and self-paced training, including project management of development of materials, delivery of topics, related to training and controlled procedures, and facilitation of sessions; supervises administrative staff in scheduling sessions and preparation of materials and equipment.
  • Generates quality metrics related to training and controlled procedures for management review and continuous improvement initiatives.
  • Supports health authority inspections, as needed.

Qualifications

  • Bachelor’s degree and 10+ years’  pharmaceutical industry experience with 5+ years’ experience directly supporting GxP Quality Management Systems.
  • Experience with e-learning and electronic Quality Management Systems is a plus, particularly ComplianceWire LMS and Veeva QualityVault.
  • Strong administrative skills, including Microsoft Office Suite (PowerPoint, Word, Excel, and Visio).
  • Ability to work independently to solve problems.

Radius Health, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Radius Health, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.

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