QC Senior Manager Microbiology
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Hobson Prior are currently working with a gene therapy organisation who are determined to develop possible curative treatments for patients who are living with serious illnesses. This ground-breaking company is looking for a QC Senior Manager Microbiology to manage the Microbiological QC team and, Sterility Assurance across the network and sites.
- Ensure day-to-day leadership of the QC Micro laboratory ensuring the laboratory is inspection ready and that any data generated is valid an in compliance with applicable internal and external cGMP requirements.
- Manage and lead the QC Micro teams and all aspects of the people process including hiring, on-boarding, mentoring, coaching, annual objective setting, performance management and employee development.
- Accountable for resource management and for initiating timely resource planning for the QC Micro teams based on production forecasts and business needs.
- Ensure enough capacity (people, materials, equipment) for QC Micro is available to meet business needs and manufacturing schedule.
- Ensure QC Micro analysis are planned, effectively tracked, monitored and achieved in accordance with agreed timelines.
- Prepare, plan and execute Internalisation of QC Micro analysis in accordance with business strategy.
- Ensure that QC Micro methods and assays are qualified and validated in accordance with the product lifecycle (e.g. phase I, II, III and commercial).
- You will act as the QC Micro representative during Regulatory Inspections and audits.
- Ensure timely escalation and resolution of issues to site leadership team.
- Authorize, review, approve and/or prepare quality documents and technical documentation as required.
- Review & approve GMP documentation e.g. deviation and any change proposals related to QC Micro.
- Staying up to date with best practice, regulatory intelligence and sharing that knowledge.
- Any other assigned duties.
- Demonstrable audit and client facing experience.
- Good Collaboration, Communication and Conflict resolution skills.
- Good technical writing skills.
- Ability to work in a fast-paced environment essential.
- Science based Degree e.g. MSc or PhD.
- A strong background within a similar environment where you have successfully led a QC Microbiology department at this level.
- Substantial experience minimum 10 years' working in a Pharmaceutical/Biotech QC function within a sterile manufacturing site.
- Substantial experience minimum 5 years' leadership experience in the Pharmaceutical/Biotech industry.
- Substantial experience minimum 5 years' and 'hands-on' knowledge of QC Microbiological analytical technologies and methods.
- Has extensive knowledge of sterile processing at a supervisory/management level, ideally will have managed one or more sterile production lines.
- Experience with validation of sterile processes.
- Involvement in capital projects (new build/refurbishment of sterile lines) would be advantageous.
- Intimate working knowledge and application of Annex 1 and similar guidance.
- Proficiency in a body of information required for the job e.g. legislation, guidelines and requirements related to QC microbiology method qualification and validation, QC processes, equipment and systems, including Computer System e.g. of EU GMP requirements for Advanced Therapy Medicinal Products, EU/FDA GMP guidelines, EU Annex 1, EU Annex 11 & CFR Part 11 and ICH guidelines Q1-Q10.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
£40000 - £42000 per annum
Hobson Prior are looking for a Microbiology Team Coordinator to join a world-wide pharmaceutical organisation on a permanent basis.