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Senior Manager, Quality Control

Chicago, IL

Posted: 09/24/2020 Employment Type: Direct Hire Job Category: Clinical: Quality Job Number: 2634

Job Description


The Senior Manager of Quality Control position is a hands-on role providing support for all aspects of Quality Control for clinical and commercial products. The position will provide expertise in drug substance (API), drug product and device analytical testing. Specifically, the role will provide support to release and stability testing of products, including providing support to investigations related to OOS/OOT results, nonconformances, deviations and other product associated incidents. The role will also oversee or support stability programs related to mid-stage clinical to commercial programs. The position will ensure timely and appropriate analytics activities to meet project target profiles and ICH, USP, FDA, and EMA standards. The Senior Manager will effectively communicate results and issues to peers and management with excellent professional standards. 

Duties and Responsibilities:

Manage Quality Control operations at contract sites (CDMO, CMO, Laboratories, etc.). Responsibilities include, but may not be limited to:
  • Managing contract relationships
  • Managing Contract Approval Forms, Purchase Orders and updates when required
  • Participating in vetting and selecting appropriate contract testing labs through the supplier management process
  • Supporting material qualification processes
  • Supporting the coordination of testing of raw, intermediate and final product through the global supply chain
  • Managing analytical methods validation and transfer to/from contract testing labs
  • Overseeing release and stability testing operations at contract sites
  • Ensuring timely and appropriate analytics activities to meet project target profiles and ICH, USP, FDA, and EMA standards 
  • Manage/validate SLIMstat software and trend manufacturing/stability data
  • Participating in the preparation of analytical, testing, and specification sections of regulatory submissions and communications
  • Adhering to CMC/QC budgets

Support Mid/late Stage clinical and commercial stability programs. Responsibilities include, but may not be limited to:
  • Supporting the clinical stability programs for mid-to-late stage products
  • Supporting the commercial stability programs for commercial products
  • Managing stability sample storage and testing at contract sites
  • Managing API retain and reference standard storage
  • Participating in the preparation of stability sections for drug substance and drug product sections of regulatory submissions

Qualifications:
  • Bachelor’ s/Master’ s degree in biology, chemistry, or similar discipline and 10+ years of experience working with pharmaceuticals/biopharmaceuticals, or Ph.D. and 5 to 10years experience
  • A minimum of 5 years in a supervisor or manager role in a GMP pharmaceutical/biopharmaceutical environment, including knowledge of analytical requirements for clinical-phase and commercial products
  • Experience in Quality Controls and analytical method validation operations
  • Solid understanding of Quality Systems in support of investigations and quality events
  • Ability to effectively work with R&D scientists, CMC engineers, Supply Chain, Regulatory Affairs, and Quality Assurance functions
  • Must be results oriented and have demonstrated interpersonal and communication skills
  • Strong organization, prioritization, and time-management skills
  • Proficient with Microsoft Word, PowerPoint, Outlook, and Excel, as well as web-based software for various applications
  • Experience in the use and application of statistical software. For example, SLIM, JMP, etc.

Meet Your Recruiter

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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