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Director, Quality Assurance

Company: Michael Page
Location: Providence
Posted on: September 24, 2022

Job Description:

The Quality Assurance Director supports and provides leadership to the Quality Assurance organization in areas of cGMP Operations, Quality Systems, Validation, Inspection Readiness, Supplier Management, Compliance, Auditing, Documentation, and Training. This individual will provide leadership and support in the development, design, and implementation of cross funtional GMP processes, associated procedures, systems, and policies.Client DetailsThis client is an innovative biopharmaceutical company with a focus on the use of proprietary orphan drug biological drug device combination technology to deliver CGT factors for the treatment of chronic eye disease of the retina.Description

  • Lead Quality Assurance team member direct reports, inclusive of Associates, Specialists, and Managers
  • Coaches / mentors staff as a means to ensure performance towards goals and provide professional development
  • Serve as a member of the Quality Leadership and / or Quality Management Teams and advise management on Quality practices, issues of concern and resolution strategies and tactics with partners
  • Cross functional partner with management and associates in Manufacturing, Quality, Operations and Development
  • Providing advice and expertise to employees and colleagues to ensure the development, management, and implementation of Quality policies
  • Advocating an employee quality culture of meeting company's values of working hard and sharing the enjoyment of contributing successfully at delivering for company's patients; support attracting, retaining, and developing our people for the health of others
  • Lead Quality Operations and Quality Management System processes (Lot Disposition, Deviation, Change Control, CAPA, OOS, Complaints, etc.).
  • Deliver training activities sharing expertise in GMP operations and compliance
  • Developing strategies to ensure best practices and processes are incorporated into procedures and specified required training
  • Adminster Quality oversight of company's GxP document lifecycle states in the DMS
  • Support and manage Management Reviews, Annual Product Reports, and Material Review Board Investigations
  • Lead metric and trend reporting with communicating periodic assessment of the health of company's quality systems to drive anticipating and preventing issues and a continuos improvement quality cultureProfile
    • Bachelor's Degree or higher in Science or Engineering or equivalent combination of education and experience (BS degree w/ minimum of 15 years; MS degree w/ minimum of 10 years, PhD w/ minimum of 7 years)
    • Minimum of 10 years of Quality Assurance work experience within the cGMP biopharmaceuticals or pharmaceuticals industry
    • Previous managerial and leadership experience in Quality Assurance commensurate with position responsibilities and requirements
    • Biologic or Drug Device Combination Product QA Operations or QA Systems or External QA / Compliance experience is a plus
    • Phase III Clinical Development to Commercial QA experience is a plus
    • Experience in administration and / or management of GMP documentation, training and quality event / process systems; Trackwise QMS a plus
    • Well organized, detail-oriented, and advocate for right the first time principles, ethical decision making, quality partner on the production floor; must be able to effectively prioritize and accomplish work with guaranteed time principles
    • Strong project management skills, intelligence and ability to be influential and "wear multiple hats" in a small organization to accomplish quality objectives
    • Experience in pharmaceutical operations, supply chain management, Quality on the manufacturing floor, and global environment a plus
    • Knowledge in external supplier auditing and qualification as well as GMP internal auditing
    • Extensive knowledge of GMPs, strong understanding of FDA / ICH regulations, Barr Decision and Quality Systems; Strong background in Quality Assurance / Systems
    • Proven ability to lead, partner, and document product investigations to the true root cause effectively, employing techniques such as Kepner Tregoe PSDM Job Offer
      • Competitive compensation + benefits
      • Leadership opportunity
      • Opportunity for career advancement and developmentMPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Keywords: Michael Page, Providence , Director, Quality Assurance, Executive , Providence, Rhode Island

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