Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Associate Director, Quality Assurance

Expired Job

Elixir Recruitment Solutions Nashville , TN 37201

Posted 2 months ago

Job Description

Reporting to the Director of Quality, the Associate Director of Quality Assurance will be responsible for oversight of department activities, development of personnel, and ensuring quality of deliverables within his/her purview. This individual will be recognized as an expert in the principles and application of quality assurance and compliance and will be responsible for development of strategic group goals and projects ensuring alignment with corporate goals and compliance with all regulatory requirements.


  • Support and maintain the client's Quality Management System (QMS)
  • Oversight of client's vendor management program
  • Development of Quality Assurance team and individual development
  • Execution, coordination, and tracking of any assigned QMS procedures and related activities which may include internal audits, external audits, change management, document management, training management, batch review/release, deviation investigations, CAPAs, complaints, recalls, regulatory inspection management, quality risk management and management review coordination
  • Assembly, monitoring and/or presentation of QMS metrics updates and status reports
  • Develop and maintain compliant quality processes to support GMP activities
  • Participate in inspection readiness activities
  • Represent Quality Assurance during audits and perform internal and external audits


  • M.S (or equivalent degree) and 4-6 years of relevant work experience, or a BS or BA in a scientific or related field (or equivalent degree) and 8+ years of biotech/pharma industry experience
  • Demonstrated success as a team leader with a focus of team and individual development
  • Experience providing QA support and oversight of GMP manufacturing for development programs including batch release of drug product
  • Experience with multiple regulatory agencies across applicable GxPs during inspections
  • Experience with investigations, root cause analysis, and CAPA
  • Contract Manufacturing Organization (CMO) or Contract Development and Manufacturing Organization (CDMO) experience desirable
  • Requires a minimum of 6 years of experience in Quality Assurance or Regulatory Compliance Management
  • Experience in pharmaceutical manufacturing environment; excellent knowledge of cGMP, ICH, USP, and global compendial regulations and regulatory guidance
  • Excellent verbal and written communication skills, experience with scientific technical writing including authoring and revising SOPs or technical reports


Comprehensive benefits package with client paying 100% of healthcare premium. Eligible for profit sharing. Start-up company with room for growth.

See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Quality Assurance Engineer


Posted 3 days ago

VIEW JOBS 11/16/2018 12:00:00 AM 2019-02-14T00:00 Why HealthTrust? HealthTrust is the industry's leading group purchasing organization (GPO), providing sustainable savings for supplies and expert sourcing for medical device and purchased services. With an annual purchasing volume by our members of over $18 billion, membership includes over 1,400 not-for-profit and for-profit acute care facilities and 10,600 surgery centers, alternative sites and physician practices. Founded in 1999, HealthTrust is organized as a limited partnership. A wholly-owned, indirect subsidiary of HCA Holdings, Inc. is the general partner and operates the partnership, controlling the majority of voting interest of the GPO. All other GPO equity holders are all healthcare providers or are owned by healthcare providers. HealthTrust is the only GPO with a truly committed model—with member-driven decision making, compliant purchasing, and a national portfolio of unparalleled value. JOB DUTIES AND RESPONSIBILITIES * Adherence to the Defined QA Workflow and Quality Principles * Become the Product SME for owned applications * Manage iteration capacity requirements within the team * Define and perform iteration and regression testing * Track testing progress during the course of an iteration * Manage software defects tracking, reporting, follow-up, using a bug tracking system, and report defects to Development team and management * Collaborate with the team Developers and Business Analysts to evaluate or diagnose problems and recommend possible solutions * Help develop and manage quality practices within assigned team * Develop testing strategies that address areas such as database impacts, functional software use cases, regression testing, negative testing, error or bug retests, or usability * Follow established automation and performance tests practices * Build new automation test scripts * Maintain and debug existing automated test scripts * Plan test schedules or strategies with development team and sync around project scope or delivery dates * Provide feedback and recommendations to developers on software usability and functionality * Pair with developers to define and create Unit Tests assist in Unit Test Peer Reviews * Attend team Code Review sessions to gain technical insight for the application being built * Engage the BA prior to the start of each iteration to review User Story documentation with the purpose of identifying potential gaps in requirement or test scenarios * Maintain historical data of test results and QA artifacts EDUCATION Bachelor's Degree Preferred EXPERIENCE 1 year of relevant work experience required * Understanding of cross-functional impact of changes in relationship to software updates, bug fixes, new releases of software internally or externally developed * Beginner to Intermediate knowledge of creating SQL queries through SQL Server 2008 * Intermediate knowledge of at least one of the following C#, C , or JAVA * Intermediate understanding of Object Oriented Programming Principals * Experience using an IDE (Ex. Visual Studio) HCA Nashville TN

Associate Director, Quality Assurance

Expired Job

Elixir Recruitment Solutions