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Director Quality - Sterility Assurance

Employer
Oxford BioMedica (UK) Limited
Location
Oxfordshire
Salary
Competitive
Start date
4 Sep 2022
Closing date
4 Oct 2022

View more

Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Director/Executive

Job Details

Job description:
 

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.

 


Profile description:

 

 

 

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.

 


We offer:

 

 

 

We are a pioneering gene therapy business, and our mission is delivering life changing gene therapies to patients. We work together, motivated to make a difference, and so can you.

We are pioneers; no one else does what we do.

Gene therapy is the treatment of disease by the delivery of therapeutic DNA into a patient’s cells. It is transforming medicine as we know it, long term and potentially curative treatments for a wide range of diseases are now possible.

We are at the forefront of this exciting area. We have a strong reputation in gene therapy, with world leading expertise in lentiviral vectors. We have a leading, integrated platform of exclusive technologies to design, develop and bioprocess unique gene based medicines, both in house and with partners.

We drive credible science to realise incredible results.

Whether you’re motivated by the discovery and development of product candidates within Research, or by cutting edge tools and technologies including AI and automation of our contract development and manufacturing organisation, we can offer you a career like no other. We are excited about our future. Join us and change lives.

 

 

Company

Oxford Biomedica is a quality and innovation-led viral vector CDMO that enables its clients to deliver life-changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, Oxford Biomedica has more than 25 years of experience in viral vectors, the driving force behind the majority of gene therapies.  

Cell and gene therapy is the treatment of disease by the delivery of therapeutic genetic material (DNA or RNA), into a patient’s cells. One highly effective approach to delivering genetic information is to re-engineer existing viruses to be safe delivery vehicles (vectors) to insert the genetic material into patients’ cells. This can be achieved either by directly administering the vector to the patient (often referred to as in vivo gene therapy), or by first introducing the genetic material to cells or tissue outside of the body, before administering the cells or tissue into the patient (often referred to as ex vivo gene therapy or gene-modified cell therapy).  

Oxford Biomedica collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. Oxford Biomedica's world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise. 

Oxford Biomedica, a FTSE4Good constituent, is headquartered in Oxford, UK. It has locations across Oxfordshire, UK and near Boston, MA, US. Learn more at www.oxb.comwww.oxbsolutions.com, and follow us on LinkedInTwitter and YouTube

Life at Oxford Biomedica

We value everyone’s unique contribution, we appreciate everyone’s individuality, and every job matters.

Your contributions are recognised and appreciated. Your work-life balance matters. We recognise, develop and use your strengths. It’s a place where you are valued as a whole person, as an individual and as part of a team.

No matter who you are, or what you do, your work will make a significant difference.

We go the extra mile, every day, because we truly care. We work together as a team to achieve our life changing therapies. Our talented colleagues help to build other people’s futures, so can you. We empower each other to be our best.

We have access to like-minded scientists and engineers, working in the latest technologies.

Our community of experts create new life-saving cures. Shaping the business’ future through collaboration. Our people are on a continuous professional development journey aided by a thought-provoking environment. A place for experts to be stretched, and future experts to be nurtured. We inspire creativity and deliver great science, and so can you.

Our supportive culture invites talent, while creating future innovators.

We’ll give you a place where you can learn, grow and contribute to the future of cell and gene therapy. We create opportunities and invest in our people, promoting ongoing learning.  Our defined career pathways provide opportunities for everyone to achieve their career potential.  We make a difference, and so can you.

Company info
Website
Telephone
+44 (0) 1865 783 000
Location
Windrush Court
Transport Way
Oxford
OX4 6LT
United Kingdom

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