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Qualified Person

OxfordPermanent
Experience Dependent
Job Reference: J5634756
Updated On: 14/04/2021
Status: Now Interviewing
Hyper Recruitment Solutions
Sectors: Pharmaceutical, Biotechnology, Clinical Research Organisation, MHRA QP License Holder, Cell & Gene Therapy

Skills: Quality Assurance - Qualified Person - Permanent, Quality Assurance - Permanent, Quality Assurance - GMP, Quality Assurance - GCP, Quality Assurance - Compliance, Quality Assurance - Auditing, Quality Assurance - Quality Manager, Quality Assurance - Quality Director / Head Of Quality, Quality Assurance - Clinical Supplies, Quality Assurance - Biologics, Quality Assurance - IMP, Quality Assurance - ATMPs

Job Information

Role Overview

Hyper Recruitment Solutions have exclusively partnered with the University of Oxford & Nuffield Department of Medicine, Clinical BioManufacturing Facility to hire a Qualified Person and strategically focussed Quality Assurance professional.

As the Qualified Person, you will work with the Department Head to help define the Quality standards and strategy to ensure compliance against regulations. As the department starts to develop it's portfolio of products and develops into areas such as Gene Therapy (ATMP), you, as the Qualified Person, will play a pivotal role in developing Quality systems, culture and standards.

The University of Oxford Clinical BioManufacturing Facility have been instrumental in the development and commercialisation of products that have helped fight against: Malaria, Ebola, Covid-19, Influenza and many more. This is an opportunity for a Qualified Person to be extremely close to life saving products and breakthroughs.

Key Duties and Responsibilities

Your duties as the Qualified Person will be varied however the key duties and responsibilities are as follows:

1. You will work alongside the Department Head and the Head of Quality to help define and shape the Quality strategies moving forward. As the site develops in various areas such as Biologics, ATMPS, you will be instrumental in updating Quality standards and introducing these internally.

2. Given the nature of the work involved, As the Qualified Person at the Clinical BioManufacturing Facility, you will have direct interactions with various, global regulatory agencies. These will include the MHRA, EMA and FDA.

3. You will perform the legal duties and responsibilities conducted under the MIA, including QP certification to clinical trial of internally and externally manufactured products. Alongside the QP activities, you will work closely with the Head of Quality to help maintain and develop the Quality Management Systems.

4. You will be the main point of contact for both internal and external contacts, advising on the interpretation and application of current legislations and guidance for novel manufacturing processes, QC testing, ensuring that MHRA and EU requirements are met.

5. As an integral member of the Clinical BioManufacturing Facility team, you will be involved with training and developing future scientists and professionals both internally and externally, representing the Clinical BioManufacturing Facility at domestic and international conferences, industry bodies and various committees.

Role Requirements

To be successful in your application to this exciting opportunity as the Qualified Person we are looking to identify the following on your profile and past history:

1. You will be an eligible Qualified Person (QP) as recognised by the MHRA. Experience can be with either investigational or commercial products.

2. Experience working within a sterile, cleanroom, environment is essential. Biologics experience is desirable.

3. As an experienced Qualified Person within the life sciences, you will be experienced managing and developing Quality Systems. This will include having oversight of audit programmes, regulatory body interactions, working with various GxP's.

Key Words: Qualified Person | QP | IMP | Bio | Sterile | ATMP | Oxford | COVID | Ebola | Life Science | Quality Assurance | Quality Manager | Head of Quality | GxP | GMP | Manufacturing | Regulatory | MHRA | Gene Therapy
Chris Carey
Your Recruitment ConsultantChris Careychris.carey@hyperec.com
DisclaimerHyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.