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PDQA Senior Manager (South San Francisco hybrid-role)

Employer
AbbVie
Location
South San Francisco, California
Start date
Sep 20, 2022
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Job Details

Primarily responsible for ensuring the successful and timely release of GMP clinical supplies by providing direction and oversight of the overall manufacturing, testing and release processes of cell and gene therapy products, including critical raw material, in-process material, drug substance to drug product to finished product.

  • Serve as the QA point of contact in CMC and Supply Chain meetings and direct QA functional areas to facilitate the approval of therapeutics product to clinical trials to meet project timelines
  • Support in-licensing, out-sourcing, and external collaboration activities
  • Support the preparation of regulatory inspections and internal audits, and represents GMP Quality in inspections and audits.
  • Ensure establishment of material and product specifications including QC analytics and risk identifications.
  • Interact and influence decisions of the various R&D Directors and Vice Presidents as well as external customers and mentor Quality Engineers
  • Serve as a subject matter expert and provide consultation & training on QA specific items to internal and cross-functional groups
  • Lead complex global cross-functional process improvement along with SME.
  • Work on unusually complex technical problems and provide solutions that are highly innovative and ingenious; resolve project team issues with minimal oversight
  • Review and approve manufacturing batch records, analytical data/reports, and other GMP batch documents. Conduct batch release of cell and gene therapy products.
  • Participate and manage investigations and support OOS, deviations, CAPA and Change Management/Change Controls.
  • Ensure suitable quality agreements or quality aspects of contracts are in place between R&D and third-party manufacturers, third party laboratories, other service providers and other sites
  • Provide management of clinical supply product actions and recalls

 

  • Bachelor's degree or equivalent experience is required, typically in life sciences, engineering
  • Minimum 6+ years of biopharma industry experience in Quality Assurance, drug development or other healthcare related field; less experienced considered with advanced degree (such as in Molecular or Cell Biology, Genetics, or Biochemistry, etc) 
  • Experience with recombinant AAV vectors, lentiviral vectors, and cell therapy products is strongly preferred
  • Strong working knowledge of cGMP, FDA and EMA GMP regulation and ICH guidance documents.
  • Prior working experience in a GMP environment and/or with CDMO(s) is preferred.
  • Broad understanding of pharmaceutical manufacturing processes including manufacturing process for viral and non-viral based gene therapy products, their release assays, analytical sciences, and worldwide quality requirements for GMP is required.
  • Knowledge of regulatory compliance requirements should include historical perspectives and current trends of the regulatory agencies, especially for cell and gene therapies as they apply to the clinical manufacturing processes.
  • Good communications skills
  • Must have leadership skills and have been seen to take a position on quality issues and standards, and must be capable of clearly and logically justifying such positions.
  • Other competencies are required, e.g., making difficult decisions, relationship-building, influencing, fostering teamwork, knowledge of the business and sound judgment

*Relocation available 

Company

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Find Us
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
North Chicago
Illinois
60064
United States
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