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Director of Quality Control

Chicago, IL

Posted: 09/24/2020 Employment Type: Direct Hire Job Category: Clinical: Quality Job Number: 2633

Job Description


The Director of Quality Control provides strategic and tactical support for all aspects of Quality Control for clinical and commercial products. The Director of Quality Control provides expertise in Drug Substance (API), Drug Product and Device analytical testing and release of products. The Director of Quality Control also provides oversight of all stability programs related to mid/stage clinical and commercial programs, including shelf-life recommendations. The Director of Quality Control additionally provides principle support to investigations related to OOS, NCs, Deviations and Incidents.

Responsibilities:
  • Oversee Quality Control operations at Contract sites (CDMO, CMO, Laboratories, etc.). Responsibilities include, but may not be limited to:
  • Establishing Contract relationships
  • Vetting and selecting appropriate Contract testing through client’ s Supplier Management process
  • Overseeing the material qualification processes
  • Managing coordination of testing of raw, intermediate and final product thought the global supply chain
  • Overseeing analytical methods transfer and qualification at contract sites
  • Manage testing operations at contract sites
  • Mange and Adhere to CMC/QC budgets
  • Author analytical sections for Drug Substance and Drug Product sections of the eCDT for INDs and NDAs
  • Oversee the Mid/late Stage clinical and commercial stability programs. Responsibilities include, but may not be limited to:
  • Overseeing the clinical stability program for mid to late stage products
  • Overseeing the commercial stability program for commercial products
  • Manage stability storage and testing at contract sites
  • Recommend appropriate product shelf-life
  • Manage/validate SLIMstat software and trend manufacturing/stability data
  • Mange and Adhere to QC budgets
  • Author stability sections for Drug Substance and Drug Product sections of the eCDT for INDs and NDAs
  • Oversee Analytical/Method related Reponses to all Regulatory Submissions related to:
  • INDs/IMPDs
  • NDAs/BLAs
  • MAAs/Etc.

Qualifications:
  • Bachelor’ s degree(Master’ s/PhD preferred) in biotechnology, chemistry or related field with 15+ years of experience in the pharmaceutical industry
  • Start-up company experience a plus
  • Seasoned veteran in Quality Controls and Validation Operations
  • Deep understanding of Quality Systems in support of investigations and quality events
  • Ability to effectively work with R&D scientists, CMC engineers, Regulatory, and QA
  • Must be results oriented and have demonstrated leadership, interpersonal, and communication skills
  • Strong organization, prioritization, and time-management skills.
  • Proficient with use of Microsoft Word, PowerPoint, Outlook, and Excel and web-based software for various applications

Working Conditions:
  • Position may require travel and periodic evening and weekend work, as necessary to meet corporate goals.

 

Meet Your Recruiter

Tracey Goldthwaite
Senior Vice President

Tracey spearheads the firm’s Commercial practice and focuses on identifying and placing individuals in leadership roles within Global Marketing, Medical Affairs, New Product Planning, and Patient Advocacy and Engagement, to name a few. With 25 years of experience, she also plays a key role in the Clinical Staffing practice, recruiting top talent of all levels for positions in our core areas including Clinical Operations and Development, Regulatory Affairs, Pharmacovigilance and Program Management.

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