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Director Quality - Sterility Assurance

Date: 26-Jul-2022

Location: Oxford, GB

Company: oxfordbiom

Director Quality – Sterility Assurance

 

Do you pride yourself on your integrity? We do what’s right for employees, patients and partners, and so can you.

 

Oxford Biomedica’s Quality Assurance (QA) team is responsible for the company’s quality processes and systems, in compliance with GMP, GLP and GCP guidelines.  The team are accountable for internal and external audits, quality compliance and control.

 

The Quality Director of Sterility Assurance will be responsible for championing Sterility Assurance principles and serve as the Quality technical leader in the areas of aseptic processing (via isolators) and microbiology, depyrogenation, irradiation and sterilisation. This role will be accountable for assuring quality assurance oversight of Sterility Assurance, Aseptic Processing Program, Environmental Monitoring and Microbial Control Policies. The Primary responsibility is to maintain sterility assurance of aseptically manufactured sterile drug products and viral vector products.  This position requires in-depth understanding of cGMP regulations and guidelines related to sterility assurance and proven applications in an aseptic/sterile production environment.

 

Your responsibilities in this role would be:

  • Responsible for defining company policy and developing company strategies with respect to aseptic processing, aseptic techniques, isolator best practices, controlled environments, aseptic training & cleanroom behaviours, cleaning, disinfection, sterilisation, sterility testing and related areas.
  • Establish and maintain the company contamination control strategies and oversee aseptic programs.
  • Generate and maintain the contamination control strategy documents.
  • Overseeing sporicidal processes (inc. VHP & BI activities), decisions on occluded surfaces, aseptic and media fills / process simulations for aseptically filled products.
  • Responsible for ensuring compliance to applicable Quality Regulations, standards, and other regional requirements.
  • Providing input in the design of manufacturing and sterility testing processes, controlled environments, and packaging from a microbiological standpoint.
  • Promoting the understanding of and compliance to Sterility Assurance related regulations.
  • Leading and/or supporting major investigations related to sterility assurance events (i.e. Adverse EM trends, media fill positives, sterility positives etc.)
  • Review & approve any major/critical deviation, change proposal or other quality records with Sterility Assurance impact.
  • Ensuring that suitable aseptic programs (including training, oversight, and monitoring) are in place and effective and that all sterilization processes are appropriately managed.
  • Maintain aseptic and sterility assurance practices in alignment with current and future regulatory requirements and expectations. Conduct risk assessments, as needed, to ensure ongoing compliance.
  • Audit (or support audits) of site sterility processes and suppliers providing sterile materials or microbiological services (as required).
  • Act as sterility assurance SME with external regulators, clients, company management in addition to acting as SME for new product introductions and applicable capital projects.
  • Generate technical reports, as required, to support business needs
  • Report status of, and promote, Sterility Assurance to Senior Leadership.

 

To be successful in this role, you will have the following skills and experience:

 

  • BS degree in Microbiology or related field (advanced degree preferred)
  • Experience in biopharmaceutical industry (prefer experiences in both large and small company environments)
  • Experience of working in an aseptic manufacturing production environment, isolators & cleanrooms.
  • Isolator experience, including VHP & BIs, aseptic processing, aseptic techniques, occluded surfaces aseptic and media fills / process simulation for aseptically filled products
  • Experience of working with Sterility test isolators
  • Experience in supplier quality and management of sterile processing suppliers.
  • Sterile supplier auditing experience, desired
  • Experience of developing and influencing business strategy, desired
  • Experience in Sterility Assurance validation and product validation using varying sterilization methods.
  • Must have a high technical knowledge of Sterility Assurance & Cleanroom standards, with demonstrated experience of implementation responsibility
  • Direct experience of QA oversight of sterility assurance programs, aseptic programs, and microbial monitoring of aseptic manufacturing areas (including isolators)
  • Strong working knowledge of worldwide regulations related to aseptic practices and sterility assurance and the ability to interpret these requirements into execution compliance
  • Solid understanding of the principles of sterile manufacturing and Quality Systems required for a sterile manufacturing facility
  • Experience interacting with regulatory authorities during regulatory inspections.
  • Ability to self-manage and work effectively with internal & external stakeholders and parties, including regulatory agencies, with minimal oversight
  • Ability to identify, prioritize, and implement actions to continuously improve operations and systems and manage risks
  • Must be a strong leader and cross functional team player with ability to work effectively in a fast-paced matrixed environment while managing multiple projects simultaneously
  • Must possess excellent verbal, written communication skill and good interpersonal skills

 

Do you want to feel inspired every day? We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.

 

Collaborate. Contribute. Change lives

 

No agencies please.