uniQure

Sr. Manager, Quality Control - Lexington

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Job

Active since 06-08-2018 Job category Quality / Health / Environment ...
Location Lexington Level -
Educational level Bachelor / Graduate Employment type -
Hours 40 Salary Competitive
Key Responsibilities:
  • Oversee and manage uniQure stability program for drug substance, drug product, and any other relevant uniQure products including-
  1. Establishing stability program strategy
  2. Stability Lot selection (Process Validation, Registration, Clinical, Pivotal lots, Ad-Hoc studies, annual commitments)
  3. Generation of study protocols and approvals
  4. Selecting temperature conditions and appropriate time-points
  5. Study and testing initiation(s) windows
  6. Generation, review, and approval of stability interim and final study report(s)
  7. Data review and trending
  • Support current shelf life of uniQure products as well as extension of shelf-life, based on stability data and trends. Manage changes to stability studies through Specification Review Board and Change Control programs.
  • Manage real-time trending of stability data to identify and actively manage Out of Trends (OOTs) and Out-of-Specification (OOS) investigations for lots on stability.
  • Manage stability-related quality systems including temperature excursions, Deviations/NCRs, Change Controls, CAPAs, and Quality Investigations.
  • Support uniQure regulatory filings, submissions, and annual product reviews by overseeing compilation of accurate real-time stability data and tables
  • Manage coordination of uniQure stability samples sent to external testing laboratory(s) for testing, including sample and shipping information, as necessary.
  • Author/revise uniQure stability policy documents and SOPs as needed.
  • Support uniQure continuous improvement and ongoing compliance initiatives
  • Management of uniQure Sample management program including but not limited to–
  1. Obtaining samples from manufacturing
  2. Aliquoting and preparing samples for QC testing
  3. Pulling and preparing samples for stability testing
  4. Maintenance and inspection of retain inventory
  5. Sample destruction

Education, Experience and Additional Requirements:

  • Bachelors or Masters degree in Chemistry/Biology or related field
  • 10+ experience within cGMP/QC testing laboratory with 5+ years of stability program management
  • Proficient knowledge in current regulations and guidance documents including cGMP, ICH, FDA, and EMA requirements.
  • Flexible and adaptable to changing and evolving priorities and needs
  • Excellent communication and written skills to successfully partner with collaborators
  • Previous experience with data trending and statistical programs (JMP, MiniTab, Excel, etc) preferred

 

More information
This listing is a full-time job

Job category Quality / Health / Environment / Safety
Industry / Industries Biotechnology
Region United States
Keywords Quality Control

Contact information

Name Jennifer Wagner

Location

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