Skip to main content

This job has expired

You will need to login before you can apply for a job.

Quality Manager, R&D Material Batch Disposition

Employer
CSL Behring
Location
Holly Springs, North Carolina
Start date
Sep 29, 2021

View more

Job Details

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

Job Summary:

This position in Chemistry, Manufacturing and Controls (CMC) and Reseach Quality Assurance (CRQA) is responsible for release of raw materials and intermediates for the production of clinical trial material and provides strategic support globally as an expert in assuring quality during R&D, arranging audits of third party suppliers/venders/CROs/CMOs for supplier qualification, deviations and changes involving R&D activities, and product technical complaints. Provides strategic and technical expertise to R&D in all GMP and procedural compliance-related matters.

Major Responsibilities:

Provides quality oversight of R&D activities

  • Ensures material for clinical batches being released complies with applicable Investigational New Drug (IND)/ Investigational Medicinal Product Dossier (IMPD) requirements, current clinical trial protocol registered with the applicable health authority and phase-appropriate cGMP.
  • Ensures that batch production records, SOPs for manufacturing and testing, specifications, justifications of specifications, etc. comply with site and global SOPs/Policies and applicable regulatory requirements for the phase of development.
  • Reviews and approves executed batch records, certificates of analysis, analytical data, development/validation/qualification protocols and reports, product specification file (PSF) for compliance and completeness.
  • Coordinates batch release activities with R&D and commercial QA/Qualified Person (QP) as required, including the sponsor release for the clinical trial; establishes phase appropriate batch release procedures and as required serves as Release-Responsible Person delgate
  • Provides QA oversight as needed to the manufacture, distribution and testing of products under development in R&D, either in-house or at third party suppliers, including sterile manufacturing and liasing with global sterility assurance as required
  • May provide direct line management for the day to day activities of a small team of 1-2 QA specialists, managing their performance and development

Establishes relationships with R&D QA and other global Quality functions:

  • Acquires and maintains knowledge of Seqirus SOPs and Policies, regulatory requirements and guidance, as well as upcoming industry trends, to ensure that expert advice and appropriate QA technical support on all quality/compliance-related matters are provided to R&D and applicable sites for relevant markets
  • Provides QA support and assists R&D in use of existing systems to manage documentation, changes, deviation investigation, CAPAs, internal audit processes, commitments to Health Authorities
  • Ensures proper knowledge transfer to Site Quality during Technical Transfer to manufacturing sites
  • Reviews and approves SOPs, Work Instructions and other procedures for R&D activities within area of oversight, ensuring compliance with site and global SOPs/Policies and applicable regulatory requirements for the phase of development.

In collaboration with R&D QA and other global Quality functions:

  • Ensures risks to compliance are escalated to senior management and supports identification of mitigations and backup options with cross-functional colleagues
  • Supports internal audits, helps prepare for regulatory inspections and serves as subject matter expert for applicable area of oversight
  • Supports inspection finding responses related to production, distribution, testing and release of material for clinical trials
  • Supports the provision of accurate and timely reports on metrics, findings, risks and trends stemming from audits, inspections and deviations for management review and proposes and/or implements improvement initiatives.

Minimum Qualifications:
  • Bachelor’s degree in a scientific discipline / Life Sciences required (e.g., Biology, Microbiology, Chemistry or Pharmacy). Masters or PhD preferred.
  • 5+ years in Quality Assurance and/or in a GMP regulated environment within the pharmaceutical industry.
  • Sterile product manufacturing knowledge and experience in aseptic processing in Biologics required.
  • Experience working directly within or directly supporting a clinical or commercial manufacturing environment is required.
  • Raw Material, Drug Substance and Drug Product expertise in vaccines preferred (cell-based and/or Advanced Therapeutic Medicinal Products)
  • Experience working across different phases of R&D preferred (Product Development/GLP Toxicology, Clinical Phase 1, 2 and 3 and commercialization)
  • Experience applying GMP principles in different market areas (e.g., US and EU) preferred

Company

As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research. 


CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential. 


CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.


CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries. 
For more information visit www.cslbehring.com. Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!

Stock Symbol: CSL

Stock Exchange: Australian Securities Exchange

Company info
Phone
610-878-4000
Location
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert